Abstract

Objectives

Chronic pain management typically consists of prescription medications or provider-based, behavioral, or interventional procedures which are often ineffective, may be costly, and can be associated with undesirable side effects. Because chronic pain affects the whole person (body, mind, and spirit), patient-centered complementary and integrative medicine (CIM) therapies that acknowledge the patients' roles in their own healing processes have the potential to provide more efficient and comprehensive chronic pain management. Active self-care complementary and integrative medicine (ACT-CIM) therapies allow for a more diverse, patient-centered treatment of complex symptoms, promote self-management, and are relatively safe and cost-effective. To date, there are no systematic reviews examining the full range of ACT-CIM used for chronic pain symptom management.

Methods

A systematic review was conducted, using Samueli Institute's rapid evidence assessment of the literature (REAL©) methodology, to rigorously assess both the quality of the research on ACT-CIM modalities and the evidence for their efficacy and effectiveness in treating chronic pain symptoms. A panel of subject matter experts was also convened to evaluate the overall literature pool and develop recommendations for the use and implementation of these modalities.

Results

Following key database searches, 146 randomized controlled trials were included in the review, 54 of which investigated mind–body therapies, as defined by the authors.

Conclusions

This article summarizes the current evidence, quality, efficacy, and safety of these modalities. Recommendations and next steps to move this field of research forward are also discussed. The entire scope of the review is detailed throughout the current Pain Medicine supplement.

Introduction

Chronic pain has been described as a disease state with profound dysregulating effects on critical homeostatic systems, including endocrine, immune, sympathoadrenal, as well as peripheral and central nervous system processing [1]. A decade of war in Iraq and Afghanistan has resulted in large numbers of wounded warriors with complex chronic pain, often associated with traumatic brain injury, posttraumatic stress syndrome, and other pain-related comorbidities [2]. In 2005 alone, the United States paid $23.4 billion in annual disability to veterans, and in 2008, 14% of total Medicare expenditures were for pain. A recent examination and review of injury and chronic pain outcomes in the military, Veteran's Administration (VA), and civilian sectors has resulted in a change of perspective regarding how best to reduce the significant risks and poor outcomes associated with current treatment approaches such as overreliance on opioid medications, polypharmacy, and passive coping. These approaches often fail to address the disruption of multiple cognitive, emotional, and physical systems and additional effects of pain, which negatively impact quality of life, autonomy, function, and mood [3–6]. Accumulating evidence reports that these factors, along with low self-efficacy and poor self-regulation, are associated with increased disability and the transition from acute to chronic pain (i.e., chronification) [7–9]. Research supports the integration of active self-care complementary and integrative medicine (ACT-CIM) therapies, such as mind–body therapies, to the current biomedical model of care to assist in either the reduction or prevention of chronic pain [10–12].

ACT-CIM therapies are defined as those which 1) incorporate complementary and integrative medicine (CIM) with conventional medicine as a collaborative and integral part of the health care system, 2) involve shared patient care, practices, guidelines, and common goals to treat the well-being of the whole person [13], and 3) can be performed by individuals on their own after they have become fully trained in the practice of the therapy. These patient-centered practices acknowledge the patient's role in their own healing, allow for a more diverse treatment of complex symptoms, promote self-management, seem to be relatively safe and cost-effective, and, as a result, have the potential to provide efficient and comprehensive pain management. Because there have been no systematic reviews conducted to date that examine the full range of ACT-CIM used for chronic pain symptom management, a systematic review was conducted to evaluate the evidence base for these therapies. The full scope of ACT-CIM approaches are detailed by the authors throughout this Pain Medicine supplement, which provides evidence for the following five broad categories of modalities identified in the review: mind–body therapies, movement therapies [14], physically oriented therapies [15], sensory art therapies [16], and multimodal integrative approaches [17].

This article focuses on the current literature available on randomized controlled trials (RCTs) of mind–body therapies, defined by their focus on “interactions among the brain, the rest of the body, the mind, and behavior, and examination of the ways in which emotional, mental, social, spiritual, experiential, and behavioral factors can directly affect health” [18]. The authors consulted subject matter experts (SMEs), the Army Surgeon General's Pain Management Task Force (PMTF), as well as the National Library of Medicine Medical Subject Heading (MeSH) terminology when identifying mind–body therapies [19]. Specifically, mindfulness and meditation, relaxation (including breathing exercises), biofeedback, guided imagery and hypnosis, autogenic training, laughter therapy, and spiritual therapies (i.e., therapeutic touch, reiki, faith healing, prayer, mental healing) are considered mind–body therapies in this review (see Figure 0001); though many other modalities (e.g., tai chi, Qigong, yoga, aromatherapy) could also be categorized as such, they are instead, at the authors' discretion, described in other subsections of this supplement [14,16].

Figure 1

Mind–body therapies.

Figure 1

Mind–body therapies.

Mind–body therapies emphasize engaging both the mind and body to promote stress reduction and well-being by changing the manner in which individuals respond to their environmental or internal stressors. They can be used to treat and/or prevent a variety of conditions, including both widespread (e.g., fibromyalgia) and localized (e.g., headache, osteoarthritis, low back pain) pain disorders, but are typically used for chronic rather than acute pain; in fact, in 2007, approximately 38% of American adults and 12% of children were using some form of CIM, most commonly for musculoskeletal conditions (e.g., back, neck, joint pain), with deep breathing and meditation use showing significant increases since 2002 [20]. As such, the authors are specifically interested in comprehensively and rigorously assessing the mind–body therapies subset of literature gathered through this full systematic review in order to examine the quantity and quality of research on self-care mind–body therapies, and determine the evidence for their efficacy and safety in treating chronic pain symptoms (i.e., pain severity/intensity).

Methods

A systematic review was conducted, using Samueli Institute's rapid evidence assessment of the literature (REAL©) methodology to comprehensively and rigorously assess both the quality of the research on active, self-care complementary and integrative therapies, and the evidence for their effectiveness in treating chronic pain symptoms. All articles meeting the review's predefined inclusion criteria were assessed for methodological bias and quality using the Scottish Intercollegiate Guidelines Network (SIGN) 50 Checklist [21]. A group of SMEs (N = 9) were assembled to assess the overall literature pool of each ACT-CIM modality in pairs using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) methodology [22]. All SMEs were then convened as a working group at a 1-day meeting during which they discussed the review results and GRADE analyses for all modalities, developed overall recommendations for the use and implementation of these modalities, and outlined the next steps for moving this research field forward. The review's full methodology is detailed in another article within this supplement [19].

Study Selection

A total of 2,771 articles were yielded from the database searches. Of the 146 studies that met the systematic review's inclusion criteria (see Figure 0002 for Flow Chart), 54 RCTs were categorized as mind–body therapies[19] and investigated modalities such as meditation/mindfulness, relaxation, biofeedback, guided imagery/self-hypnosis, and autogenic training. No articles on laughter therapy, or spiritual therapies (i.e., self-therapeutic touch, self-reiki, faith healing, prayer, mental healing), as defined by the authors, met the review's inclusion criteria.

Figure 2

Flow chart of included mind–body therapy studies and eligibility criteria.

Figure 2

Flow chart of included mind–body therapy studies and eligibility criteria.

Overall Quality Assessment

According to the SIGN 50 criteria used to assess methodological bias and quality, the majority (N = 37) of studies within this category of practices were considered to be poor-quality (−), with only 17 high-quality (+) studies. Most articles addressed an appropriate and clearly focused question, dropout rates, baseline similarities between treatment groups, and outcome reliability and validity either adequately or well. Criteria surrounding randomization, allocation concealment, and intention-to-treat analyses were mostly poorly addressed, indicating that the authors of these reports failed either to successfully carry out, or to describe these processes at all. Similarly, of the two multisite studies reported [23,24], both poorly addressed similarities between study sites (see Table 0001).

Table 1

SIGN 50 [21] quality assessment of mind–body therapy studies

 Percentage (N)
 
 Poor Adequate Well 
Appropriate and clearly focused question – 57.4% (31) 42.6% (23) 
Percentage of dropouts  33.3% (18) 22.3% (12) 44.4% (24) 
Randomization  63.0% (34) 22.2% (12) 14.8% (8) 
Allocation concealment  92.6% (50)  5.5% (3)  1.9% (1) 
Baseline similarities  27.8% (15)  33.3%(18) 38.9% (21) 
Outcome reliability/validity  20.4% (11) 29.6% (16) 50.0% (27) 
Intention-to-treat analyses  74.1% (40)  3.7% (2) 22.2% (12) 
Multisite similarities 100.0% (2) – – 
 Percentage (N)
 
 Poor Adequate Well 
Appropriate and clearly focused question – 57.4% (31) 42.6% (23) 
Percentage of dropouts  33.3% (18) 22.3% (12) 44.4% (24) 
Randomization  63.0% (34) 22.2% (12) 14.8% (8) 
Allocation concealment  92.6% (50)  5.5% (3)  1.9% (1) 
Baseline similarities  27.8% (15)  33.3%(18) 38.9% (21) 
Outcome reliability/validity  20.4% (11) 29.6% (16) 50.0% (27) 
Intention-to-treat analyses  74.1% (40)  3.7% (2) 22.2% (12) 
Multisite similarities 100.0% (2) – – 

Meditation and Mindfulness

Meditation refers to a group of techniques, including mantra meditation and mindfulness meditation, that involve training the mind or inducing some mode of consciousness using a variety of techniques to induce a state of impartial, present moment awareness of sensory, emotional, and cognitive events. Meditation can be used to treat several conditions, particularly chronic pain [25,26] and stress [27,28]. Meditation is one of the more commonly used mind–body modalities, as it can be easily self-administered. In fact, its usage seems to be increasing over the past several years; according to a 2007 survey, 9.4% of respondents reported using meditation in the past year, compared with 7.6% of respondents in 2002 [20].

Similar to meditation, mindfulness refers to being aware of one's bodily functions, sensations, feelings, thoughts, perceptions, and surrounding environment, so that individuals can prioritize their feelings and thoughts, differentiating between those that are ineffective and destructive, and those that are more purposeful, and choosing which to focus on. One of the most popular mindfulness-based programs is mindfulness-based stress reduction (MBSR), first established by Jon Kabat-Zinn at the University of Massachusetts Medical School. MBSR focuses on alleviating pain and improving both physical and emotional well-being through moment-to-moment nonjudgmental awareness and other various techniques (e.g., sitting and walking meditation, body scan, Hatha yoga, loving kindness meditation). Individuals can practice MBSR on their own, with most programs generally requiring daily 45-minute meditation practices after a standard training, usually consisting of a 2.5-hour weekly group session for 8 weeks, plus an all-day retreat (30 hours), though a shorter version is now being offered and other variations of the program can be found [29].

For purposes of this review, the authors have combined mindfulness and meditation into one group of modalities and report the evidence base for the usage of these modalities for the self-management of chronic pain symptoms below.

Results

Eleven studies, involving a total of 1,209 participants, investigated the use of mindfulness/meditation for management of several pain conditions including chronic low back pain [30–33], fibromyalgia [34], failed back surgery syndrome [35], chronic pain [36], musculoskeletal pain [37], and diabetic neuropathy [38] (see Table 0002 for full description of studies). Mindfulness-meditation duration and frequency of participation (i.e., dosages) were fairly consistent, with most studies reporting 12 hours of practice over 8 weeks; 3 studies [32,33,36] did not provide full dosaging details.

It is important to note that 7 [30,31,34–37,39] of the 11 mindfulness/meditation studies reported using an MBSR program as their tool for self-management of pain. The remaining four studies did not include MBSR but included similar interventions (i.e., affective self-awareness, a loving-kindness meditation, Alexander technique, and a mindfulness meditation) instead [32,33,38,40]. These 11 studies were combined into this mindfulness and meditation category. As such, a small degree of heterogeneity exists for this modality and, as such, caution should be exercised when assessing this group of studies together.

Three of the five high-quality (+) studies found favorable effects for meditation/mindfulness. One study [40] reported affective self-awareness was more effective than a wait list control (WLC) for reducing pain and number of painful body regions associated with fibromyalgia. Another study found that MBSR and a multidisciplinary pain intervention program [39] were equally effective in treating chronic pain, while a third study [30] cited that a form of meditation modeled after MBSR and an education program were equally effective in improving chronic low back pain. The remaining two high-quality studies reported that neither MBSR nor a form of meditation similar to MBSR had any significant benefits for treating fibromyalgia [34] and chronic low back pain [31], respectively; control groups for these studies, moreover, also did not have any significant benefits. Within this subset of studies, most studies included dosages of either 12 [30,31] or 27 hours [34,39] over 8 weeks, with one study reporting 7.5 hours over 3 weeks [40]. Only two studies [30,31] mentioned adverse events, with both reporting no adverse events occurred.

Six studies were scored as poor quality (−). Of these, one study showed that MBSR was more effective than a WLC in alleviating pain associated with failed back surgery syndrome [35], while a second study reported that MBSR and an education program were equally effective in treating chronic pain [36]. Similarly, another study [32] demonstrated that although all groups (i.e., massage, six Alexander technique lessons, 24 Alexander technique lessons, exercise, normal care) were found to effectively treat chronic low back pain, 24 Alexander technique lessons were more effective than the other groups. A Loving Kindness Meditation Program, moreover, showed reductions in chronic low back pain; between-group differences comparing this program with usual care were not reported [33]. The remaining two poor-quality studies showed that neither MBSR, compared with standard care and massage, nor mindfulness meditation, compared with an attention-placebo, were effective treatments for musculoskeletal pain [37] and diabetic neuropathy [38], respectively. Dosages were a little more inconsistent regarding this subset of studies; 2 studies recommended 12 hours over 8 weeks [33,35], 1 recommended 20 hours over 8 weeks [37], and the remaining 3 studies [32,36,38] did not provide adequate dosaging detail. Only two studies [32,37] reported on adverse events, citing that no such events occurred.

GRADE Analysis

Even as studies document the positive health benefits of meditation, the issue of safety is often neither examined nor reported. While a 2008 review concluded no known adverse effects of MBSR have been documented [41], there have been claims, although largely anecdotal, that some forms of meditation can be harmful for those with psychiatric conditions or certain physical conditions, particularly if movement is a requirement of the meditative practice [42]. Based on the four studies [30–32,37] that reported on adverse events, stating that none occurred, meditation/mindfulness appears to be relatively safe, with frequent but not serious adverse events. Because the majority of studies, however, did not report on such events, the overall safety of meditation/mindfulness, based on all 11 studies, is not well understood.

The majority of the studies showed favorable effects for mindfulness/meditation, with five studies reporting overall small effect sizes (d = 0.2–0.5). A little over half of the studies, however, were of poor quality, suffering from methodological flaws surrounding randomization, dropout rates, and safety reporting. Based on the high-quality studies reported, the SMEs agreed that further research is likely to have an important impact on the confidence in the estimate of an effect, which may change should a more highly powered, high-quality study be introduced into the literature. Given this information, paired with the lack of safety reporting, the SMEs agreed that based on the current evidence, no recommendation could be made for meditation/mindfulness as a treatment for chronic pain symptoms at this time (see Table 0003).

Relaxation

Relaxation training follows a specific method, process, procedure, or activity with the intent to release physical tension and refocus the mind away from anxious, angry, or disturbing thoughts in order to reduce stress and/or pain and achieve a sense of well-being and calmness [43]. Such trainings have been shown to slow the heart rate [44], lower blood pressure [45], decrease muscle tension [46], and decrease oxygen consumption and levels of stress hormones [47] by increasing the relaxation response and counteracting the adverse effects of the “fight or flight” response characterized by signs and symptoms such as raised cholesterol levels, disturbed intestinal activities, a depressed immune system, and a feeling of being “stressed out” [43]. To achieve the most benefit, relaxation trainings are often combined with other modalities [48] and can be self-administered once an individual has been properly trained in relaxation techniques. Multimodal integrative relaxation therapies included in this review are detailed in another article within this supplement [17].

Results

Nine high-quality (+) [49–57] and 13 poor-quality (−) studies [24,58–69], consisting of a total of 1,603 participants, investigated relaxation as a treatment for a variety of chronic pain conditions such as rheumatic conditions [24,54,59,63], chronic low back pain [51,52], chronic headaches [49,55,62,64–67,69], cancer pain [57], irritable bowel syndrome [56], fibromyalgia [50], neck pain [53], temporomandibular disorders [60,68], and other chronic pain conditions [58,61] (see Table 0002 for full description of studies). Relaxation dosages were fairly inconsistent, ranging from 0.75 hours over 1 day to 10 hours over 10 weeks.

Table 2

Characteristics of mind–body therapy studies

Citation Total Participants, Condition Interventions # Assigned (Dropout %) Dosage (Total Hours/Time Period) Relevant Pain Outcomes Conclusions Quality 
Meditation/Mindfulness (N = 11) 
 Hsu et al. [40] 45, Fibromyalgia ASA 24 (13%) 7.5 hours/3 weeks BPI (pain severity): P = 0.03 at PT; P < 0.01 at FU; ES: d = 1.14 at PT, d = 1.46 at FU ASA is more effective than WLC for reducing pain and number of painful body regions post intervention and at 6 months follow-up. 
WLC 21 (0%) ND BPI (number of painful body regions): P < 0.001 at PT; P = 0.001 at FU 
 Wong [39] 100, Chronic pain MBSR 51 (20%) 19 hours/8 weeks NRS (pain): p < 0.05** (both groups); P = NS Both MBSR and MIP programs are equally effective in reducing chronic pain intensity. 
MIP 49 (8%) 12 hours/ND 
 Morone [30] 40, Chronic low back pain Meditation 20 (20%) 12 hours/8 weeks SF-MPQ (pain): P = Sig** (both groups) over time; P = NS Both the meditation and the education program are equally effective in improving chronic low back pain. 
Education 20 (5%) 12 hours/8 weeks SF-36 Pain Subscale (pain intensity): P = Sig** (meditation) over time; P = NS at FU 
 Schmidt [34] 177, Fibromyalgia MBSR 59 (10%) 19 hours/8 wks PPS (sensory and affective pain): P = NS** None of the groups (MBSR, active control, WLC) were effective in treating fibromyalgia pain. 
WLC 59 (0%) ND 
Active control 59 (5%) 12 hours/8 weeks 
 Morone [31] 37, Chronic low back pain Meditation 19 (32%) 12 hours/8 weeks SF-MPQ (pain intensity): P = NS; ES: d = 0.32 Neither meditation nor WLC was effective in improving chronic low back pain. 
WLC 18 (5%) ND SF-36 Pain Subscale (pain): P = NS; ES: d = 0.16 
 Esmer [35] 40, Failed back surgery syndrome MBSR 19 (21%) 12 hours/8 weeks VAS (pain): P < 0.021 at wk 12; P = Sig at FU; ES: d = 1.02 MBSR is more effective than WLC in reducing pain associated with failed back surgery syndrome.  
WLC 21 (24%) ND 
 Ehrlich [32]* 579, Chronic low back pain Alexander technique (6 tx) 579 (20%) ND Von Korff Scale (pain): P = Sig (Alexander technique 24, exercise/control) at month 12 Both 6 lessons and 24 lessons with Alexander Technique, followed by exercise, are equally effective in treating chronic back pain.  
Alexander technique (24 tx) ND 
Massage ND 
Exercise ND 
Normal care ND 
 Wong [36] 100, Chronic pain MBSR 100 (ND) ND NRS (pain intensity): P = Sig** (both groups) at mo 6; P = NS Both MBSR and the education program are equally effective in improving chronic pain intensity.  
Education ND 
 Carson [33] 43, Chronic low back pain Loving-kindness meditation 43 (ND) 12 hours/8 weeks MPQ (pain intensity): P = Sig** (meditation); P = NS** (UC); ES: d = 0.42 A meditation program is effective in lowering chronic low back pain scores.  
UC ND/8 weeks 
BPI (usual pain, worst pain): P < 0.01** (meditation, usual pain); P = 0.05** (meditation, worst pain); P = ND; ES: d = 0.42 
 Plews-Ogan [37] 30, Musculoskeletal pain MBSR 10 (30%) 12 hours/8 weeks NRS (pain sensation and unpleasantness): P = Sig (massage, unpleasantness) at FU; P = NS** (MBSR, SC); P = NS MBSR is not effective for reducing musculoskeletal pain; however, massage is more effective than SC for reducing musculoskeletal pain.  
Massage 10 (10%) 8 hours/8 weeks 
SC 10 (20%) ND 
 Teixeira [38] 22, Diabetic neuropathy Meditation 11 (9%) 1 hour/1 day NPS (pain intensity): P = NS** at PT ES: d = 0.16 Neither mindfulness meditation nor attention-placebo effectively reduced pain associated with diabetic neuropathy.  
Attention-placebo 11 (9%) 1 hour/1 day 
Relaxation (N = 22) 
 Stenstrom [54] 54, Inflammatory rheumatic disease PMR 27 (0%) ND/12 months Nottingham Health Profile Pain Subscale (pain): P = NS at PT PMR shows minor improvements in the reduction of pain; no differences between groups noted. 
DMT 27 (0%) ND/12 months 
AIMS2 Pain Impact Subscale (pain): P < 0.05** (relaxation), P = NS at PT 
 Mehling [52] 36, Chronic low back pain Breathing 18 (11%) 9 hours/6 weeks VAS (pain intensity): P < 0.005** (both groups) at PT; P < 0.005** (both groups), P = NS at FU Both breath therapy and physical therapy were equally effective in reducing pain and disability associated with low back pain. 
PT 18 (33%) 9 hours/6 weeks 
SF-36 (bodily pain): P < 0.005** (both groups) at PT; P < 0.005** (both groups), P = NS at FU 
 Larsson [55] 41, Chronic headaches TAR 14 (14%) 8.25 hours/ND Headache Activity (headache activity): P < 0.05e (TAR/SM), P < 0.05e (SHR/SM) at PT and post-booster; P < 0.01d (SHR) over time; P < 0.01d (TAR) at FU; P = NSe (TAR/SHR) Both therapist and self-help relaxation are equally more effective than no treatment for reducing chronic headache pain. 
SHR 16 (13%) ND/ND 
Self-monitoring (SM) 11 (9%) ND 
 Poole [51] 234, Chronic low back pain Relaxation 82 (30%) 6 hours/6 weeks SF-36 Pain Subscale (pain): P < .0005** (all groups) over time; P = NS Relaxation, usual care, and reflexology are all equally effective in reducing chronic low back pain. 
UC 75 (43%) ND 
Reflexology 77 (16%) 6 hours/6 weeks 
VAS (pain): P = NS** 
 Anderson [57] 59, Cancer pain Relaxation 16 (63%) 3.3 hours/2 weeks BPI (pain): P < 0.05 (WLC/all groups, worst pain) at wk 7; P < 0.05** (PMD, WLC, pain severity) at PT; P < 0.05** (positive mood, WLC, average pain) at PT Distraction and WLC were equally effective in improving pain severity, while positive mood and WLC were equally effective in improving average pain scores. Furthermore, both relaxation and distraction groups reported immediate posttreatment pain reduction. 
PMD 16 (44%) 3.3 hours/2 weeks 
Distraction 13 (46%) 3.3 hours/2 weeks 
WLC 14 (43%) ND 
Pain Intensity Rating (pain): P < 0.03** (relaxation, PMD) at PT 
 Boyce [56] 105, Irritable bowel syndrome Relaxation 36 (64%) 4 hours/8 weeks SF-36 (bodily pain): P < 0.01** (all groups) over time; P < 0.05 (UC) over time All groups were equally effective in treating pain associated with irritable bowel syndrome. 
CBT 35 (49%) 8 hours/8 weeks 
UC 34 (38%) 0.75 hours + 190.4 g psyllium hus/ND 
 Trautmann [49] 65, Migraine, tension headache or combined migraine/tension headache Applied relaxation 22 (14%) ND/6 weeks Headache Diary (headache intensity): P = NS**; ES: d = 0.0 (CBT), d = −0.27 (AR), d = −0.11 (EDU) None of the groups (applied relaxation, education, cognitive behavioral therapy) are effective for reducing intensity of recurrent headache pain. 
Education 19 (47%) ND/6 weeks 
CBT 24 (54%) ND/6 weeks 
 Hammond [50] 183, Fibromyalgia Relaxation 86 (28%) 10 hours/10 weeks FIQ (pain): P = NS** Neither the relaxation nor the patient education are effective in reducing fibromyalgia pain. 
Education 97 (27%) 20 hours/10 weeks 
 Gustavsson [53] 37, Long-lasting neck pain Applied relaxation 18 (11%) 10.5 hours/7 weeks Ordinal Scale of Pain (pain intensity): P = NS** Neither the relaxation group nor treatment as usual group effectively reduced neck pain. 
UC 19 (11%) ND 
 Wahlund [60] 122, Temporo-mandibular disorders Relaxation 41 (17%) ND/ND VAS (pain): P < 0.01 (occlusal appliance/ brief information); P = NS (relaxation/occlusal appliance); P = ND** (relaxation/brief information) Occlusal appliance is more effective than brief information training in the reduction of pain intensity associated with temporomandibular disorders; no significant differences between the occlusal appliance and the relaxation training group or relaxation and brief information groups.  
Occlusal appliance 42 (12%) ND 
Brief information 39 (0%) 0.5 hours/1 day 
 Larsson [65] 48, Tension headache Relaxation 31 (0%) ND/5 weeks Headache Index (headache parameters): P < 0.05(peak intensity, headache frequency, headache free days), P = NS (headache duration) at PT Relaxation training program is more effective than WLC in reducing tension headache pain.  
WLC 17 (0%) ND 
 Loew [64] 54, Tension headache EFR 27 (11%) 0.75 hours/1 day Standardized Pain Diary (pain intensity): P = 0.003(intense pain), P = 0.03(medium pain) at PT EFR is more effective than an unspecified intervention in reducing tension headache pain intensity.  
Unspecified intervention 27 (56%) 0.75 hours/1 day 
 Larsson [67] 26, Chronic tension-type headache Relaxation 13 (0%) 4.2 hours/5 weeks Headache Activity (headache): P < 0.05 School-based, nurse-administered relaxation training program is more effective than no treatment in reducing chronic tension-type headaches in school children.  
NT 13 (0%) ND 
 Larsson [66] 32, Chronic headaches Relaxation training 12 (9%) 4.2 hours/5 weeks Headache Activity (headache parameters): P = NS (all groups, headache intensity); P = Sig (relaxation/information contact, headache sum); P = Sig (relaxation/NT, headache sum) at PT; P = NS (headache sum score) at FU Relaxation is more effective than information contact and no treatment in reducing weekly headache intensity at end of treatment; however, no differences were noted at follow up.  
Information contact 13 (0%) ND/ND 
NT 7 (0%) ND 
 Thorsell [61] 115, Chronic pain Applied relaxation 61 (46%) 3 hours/2 days OMPQ (pain intensity): P = NS** (applied relaxation) at PT, months 6, 12; P < 0.05** (ACT) at PT, month 6; P = ND; ES: d = −0.37 (ACT at PT), d = −0.47 (ACT at month 12) Applied relaxation is not as effective as ACT in treating chronic pain symptoms.  
ACT 54 (43%) 3 hours/2 days 
 McGrath [62] 99, Migraine Relaxation training 32 (38%) 6 hours/6 weeks Headache Diary (headache): P < 0.05** (all groups) over time; P = NS Both relaxation and placebo treatments are equally effective in reducing migraine pain.  
Placebo 37 (43%) 6 hours/6 weeks 
Own best efforts 30 (30%) ND 
 Blanchard [69] 39, Tension headache PMR + home practice (PMR+) 39 (15%) ND/8 weeks Headache Diary (headache): P = 0.005** (PMR+), P = 0.04** (PMR), P = Sig (PMR+, PMR/WLC), P = NS (PMR+/PMR) at PT Both PMR + home practice and PMR are equally more effective than WLC in reducing headache intensity.  
PMR ND/8 weeks 
WLC ND 
 Barsky [59] 168, Rheumatoid arthritis Relaxation response 44 (27%) 6.7 hours/ND Rheumatoid Arthritis Symptom Questionnaire (pain): P < 0.001** (all groups) over time, month 6; P = Sig** (education), P = NS** (CBT, relaxation), P = NS (all groups) at month 12 ES: d = 0.26–0.35 (at PT) Relaxation, arthritis education, and CBT are all equally effective in reducing pain.  
Arthritis education 56 (21%) 6.7 hours/ND 
CBT 68 (16%) 12 hours/ND 
 Linton [58] 15, Chronic pain Applied relaxation 15 (0%) 6 hours/4 weeks 5-Point Likert Scale (pain intensity): P = Sig (applied relaxation/WLC) at PT; P = Sig** (all groups) over time Although all groups were effective in reducing pain, applied relaxation seems to be more effective than applied relaxation + operant conditioning and WLC.  
Applied relaxation + operant conditioning ND/4 weeks 
WLC ND 
 Funch [68] 57, Chronic temporomandibular joint pain Relaxation 30 (0%) 1 hour/ND 6-Point Likert Scale (pain rating): P = NS** Neither relaxation nor biofeedback is effective in reducing chronic temporomandibular joint pain.  
Biofeedback 27 (0%) 0.2 hours/1 day 
 Lundgren [63] 68, Rheumatoid arthritis Relaxation training 37 (11%) 10 hours/10 weeks VAS (pain): P = NS** Neither muscle relaxation training nor a no-treatment control group are effective in reducing pain associated with rheumatoid arthritis.  
NT 31 (13%) ND 
 Gay [24] 41, Osteoarthritis pain Relaxation 14 (7%) 4 hours/8 weeks VAS (pain): P < 0.0004 (hypnosis/relaxation, hypnosis/WLC), P = NS (relaxation/WLC) at week 4; P < 0.003 (hypnosis/WLC, relaxation/WLC), P = NS (hypnosis/relaxation) at PT; P < 0.004 (hypnosis/WLC), P = NS (hypnosis/relaxation, relaxation/WLC) at month 3, P = NS (all groups) at month 6 Hypnosis is more effective than both relaxation and WLC in reducing osteoarthritis pain at 4 weeks; however, both hypnosis and relaxation are equally more effective than WLC at 8 weeks. None of the groups were effective at 6 months.  
Hypnosis 14 (7%) 4 hours/8 weeks 
WLC 13 (23%) ND 
Biofeedback (N = 13) 
 Kapitza [76] 42, Chronic low back pain Respiratory feedback 21 (0%) 7.5 hours/15 days Pain Diary (pain): P < 0.02** (respiratory biofeedback, pain at rest/during activity), P = 0.014** (placebo biofeedback, pain during activity) at month 3; P = NS** (placebo biofeedback, pain at rest), P = NS Respiratory biofeedback is more effective than placebo biofeedback in reducing pain 3 months post intervention. 
Placebo biofeedback 21 (0%) 7.5 hours/15 days 
 Scharff [80] 36, Migraine in children Handwarming biofeedback 13 (0%) 4.5 hours/6 weeks Headache Index (headache intensity): P = Sig** (all groups), P = NS (all groups) at month 12 Both handwarming biofeedback and handcooling biofeedback seem to be equally effective in reducing headache intensity over time. 
Handcooling biofeedback 11 (9%) 4.5 hours/6 weeks 
WLC 12 (8%) ND 
 Bruhn [82] 28, Chronic muscle contraction headache EMG biofeedback 14 (7%) 5.3 hours/8 weeks Headache Diary (headache intensity): P < 0.01** (biofeedback) at last 2 weeks of therapy; P = ND** (UC); P = ND EMG biofeedback therapy is effective in reducing severe muscle contraction headaches at posttest; no between group differences were reported.  
UC 14 (29%) ND 
 Kayiran [83] 40, Fibromyalgia Neurofeedback sensory motor training 20 (10%) 10 hours/4 weeks VAS (pain intensity): P < 0.05 at every PT visit Neurofeedback Sensory Motor Training is more effective than escitalopram in reducing pain associated with fibromyalgia.  
Escitalopram 20 (10%) 560 mg/8 weeks 
 Babu [84] 30, Fibromyalgia EMG biofeedback 15 (0%) 4.5 hours/6 days VAS (pain): P = 0.000 EMG biofeedback is more effective than sham biofeedback in reducing fibromyalgia pain.  
Sham biofeedback 15 (0%) 4.5 hours/6 days 
 Nelson [85] 42, Fibromyalgia LENS 21 (24%) ND/ND NRS (pain intensity): P < 0.001** (LENS, pain intensity of past 24 h); P = NS** (placebo, pain intensity of past 24 h); P = ND** (both groups, current pain intensity); P = ND LENS treatment is more effective than placebo biofeedback at alleviating fibromyalgia pain.  
Placebo biofeedback 21 (24%) ND/ND 
 Ma [86] 60, Neck and/or shoulder pain Biofeedback 15 (33%) 24 hours/6 weeks VAS (pain): P < 0.04** (biofeedback, active exercise, PassTx), P = NS** (education), P = Sig (education/other groups), P = NS (active exercise/ PassTx) at PT; P = 0.00 (biofeedback/other groups) at PT, month 6; Biofeedback was more effective than active exercise, passive treatment, and an education group in reducing neck and shoulder pain.  
P < 0.02 (active exercise/ PassTx, education), P = NS (PassTx /education) at month 6 
Active exercise ND 57.3 hours/6 weeks 
PassTx ND 7 hours/6 weeks 
Education book 15 (40%) ND/6 weeks 
 Simon [87] 30, Chronic constipation EMG biofeedback 15 (0%) 6 hours/1 month 10-Point Likert Scale (pain): P < 0.01** (biofeedback) at FU; P = NS** (counseling); P = Sig EMG biofeedback is more effective than counseling for reducing pain associated with chronic constipation in elderly patients.  
Counseling 15 (0%) 6 hours/1 month 
 Newton-John [78] 44, Chronic low back pain EMG biofeedback 16 (38%) 8 hours/4 wks Pain Diary (pain severity): P < 0.007 (biofeedback/WLC, CBT/WLC); P = NS (biofeedback/CBT) Both CBT and EMG biofeedback were equally more effective than WLC in reducing self-monitored chronic low back pain.  
CBT 16 (19%) 8 hours/4 weeks 
WLC 12 (ND) ND 
 Bohm-Starke [88] 35, Provoked vestibulodynia Surface EMG biofeedback 17 (0%) 40 hours/4 months VAS (pain intensity): P = NS** Both surface EMG biofeedback and topical lidocaine were equally effective in decreasing gastrointestinal tract, shoulder, joint, and back pain symptoms at 6 months post intervention.  
SF-36 Pain Subscale (bodily pain): P = NS** 
Topical lidocaine 18 (0%) ND/4 months 
Subjective Outcome and Bodily Pain (pain): P < 0.01**(gastrointestinal tract, joint, shoulder, back pain), P = NS at FU 
 Holroyd [81] 43, Tension headache Decrease/High 43 (12%) 5 hours/12 weeks Headache Recordings (headache intensity): P < 0.05** (Decrease/High, Increase/High, Increase/Moderate); P = NS All EMG biofeedback groups were equally more effective than the decrease/moderate group in improving tension headache pain scores.  
Decrease/Moderate 5 hours/12 weeks 
Increase/High 5 hours/12 weeks 
Increase/Moderate 5 hours/12 weeks 
 Nouwen [77] 20, Chronic low back pain EMG biofeedback 10 (0%) 10 hours/3 weeks Back Pain Log (pain): P = NS** Neither EMG biofeedback nor WLC are effective in alleviating low back pain.  
WLC 10 (0%) MD 
 Bush [79] 72, Chronic low back pain Biofeedback 23 (9%) 4 hours/ND Daily Low Back Pain Record (pain severity): P = NS (all groups) Neither EMG biofeedback nor placebo is effective in treating chronic low back pain in a nonhospitalized population.  
Placebo 24 (4%) 4 hours/ND 
WLC 25 (0%) ND 
MPQ—PPI (present pain severity): P = NS (all groups) at PT 
Guided Imagery/Self-Hypnosis (N = 6) 
 Menzies [95] 48, Fibromyalgia GI 24 (0%) ND/10 weeks SF-MPQ PPI Subscale (present pain intensity): P = NS** Neither guided imagery nor usual care were effective in reducing fibromyalgia pain. 
UC 24 (0%) ND/10 weeks 
SF- MPQ VAS Subscale (pain): P = NS** 
 Fors [96] 58, Fibromyalgia GI 17 (0%) 0.5 hours/1 day VAS (pain): P < 0.001** (GI and patient education) at PT; P < 0.05 (GI/pain-related talk, patient education/pain-related talk); P = NS (GI/patient education); P = NS** (pain-related talk) Both guided imagery and patient education are equally more effective than a pain-related talk group in reducing short-term fibromyalgia pain.  
Pain-related talk 19 (0%) 0.5 hours/1 day 
Patient education 22 (0%) 0.5 hours/1 day 
 van Tilburg [97] 34, Abdominal pain GI + SMC 19 (16%) ND/8 weeks Abdominal Pain Index (parent report of pain intensity and pain severity): P < 0.05** (GI + SMC), P = ND at PT, FU Guided imagery plus standard medical care is effective in reducing pain associated with the abdomen.  
SMC 15 (0%) ND 
 Patterson [98] 21, Physical trauma injuries VRH 21 (22%) 8 hours/1 day GRS (pain): P < 0.05** (VRH, NT, pain intensity, pain unpleasantness), P < 0.05** (VRH, least pain intensity in past 8h), P < 0.05** (NT, least pain intensity in past 8h), P = NS at PT VRH is effective in reducing pain intensity and unpleasantness associated with physical trauma injuries, whereas the control group reported increases in these areas; no significant between group differences were noted.  
Virtual reality/NT ND 
 Carrico [99] 30, Insterstitial cystitis GI 15 (27%) 46.7 hours/8 weeks VAS (pain): P = 0.027** (GI), P = NS** (WLC), P = NS at PT Guided imagery is effective in reducing insterstitial cystitis pain, whereas the control group indicated no changes; no significant difference between groups were noted.  
WLC 15 (7%) 46.7 hours/8 weeks 
 Lewandowski [100] 44, Chronic pain GI 22 (5%) 21 minutes/3 days VAS (pain intensity): P < 0.05 at day 4, 5; P = NS at day 2, 3 Guided imagery is effective in reducing chronic pain.  
WLC 22 (5%) ND 
Autogenic Training (N = 2) 
 Asbury [23] 53, Cardiac syndrome x AT 27 (15%) 12 hours/8 weeks Symptom Monitoring Diary (symptom severity): P < 0.001** (AT), P = NS at PT Autogenic training is effective in reducing cardiac symptom pain symptom severity; no between group differences noted.  
Symptom monitoring 26 (4%) ND 
 VanDyck [107] 71, Chronic tension headaches AT 71 (23%) 10 hours/7 weeks Headache Index (pain intensity): P < 0.05** (AT, hypnotic imagery) over time; ES: d = 0.45 Both autogenic training and future-oriented hypnotic imagery were equally effective in reducing chronic pain.  
Future-oriented hypnotic imagery 10 hours/7 weeks 
Citation Total Participants, Condition Interventions # Assigned (Dropout %) Dosage (Total Hours/Time Period) Relevant Pain Outcomes Conclusions Quality 
Meditation/Mindfulness (N = 11) 
 Hsu et al. [40] 45, Fibromyalgia ASA 24 (13%) 7.5 hours/3 weeks BPI (pain severity): P = 0.03 at PT; P < 0.01 at FU; ES: d = 1.14 at PT, d = 1.46 at FU ASA is more effective than WLC for reducing pain and number of painful body regions post intervention and at 6 months follow-up. 
WLC 21 (0%) ND BPI (number of painful body regions): P < 0.001 at PT; P = 0.001 at FU 
 Wong [39] 100, Chronic pain MBSR 51 (20%) 19 hours/8 weeks NRS (pain): p < 0.05** (both groups); P = NS Both MBSR and MIP programs are equally effective in reducing chronic pain intensity. 
MIP 49 (8%) 12 hours/ND 
 Morone [30] 40, Chronic low back pain Meditation 20 (20%) 12 hours/8 weeks SF-MPQ (pain): P = Sig** (both groups) over time; P = NS Both the meditation and the education program are equally effective in improving chronic low back pain. 
Education 20 (5%) 12 hours/8 weeks SF-36 Pain Subscale (pain intensity): P = Sig** (meditation) over time; P = NS at FU 
 Schmidt [34] 177, Fibromyalgia MBSR 59 (10%) 19 hours/8 wks PPS (sensory and affective pain): P = NS** None of the groups (MBSR, active control, WLC) were effective in treating fibromyalgia pain. 
WLC 59 (0%) ND 
Active control 59 (5%) 12 hours/8 weeks 
 Morone [31] 37, Chronic low back pain Meditation 19 (32%) 12 hours/8 weeks SF-MPQ (pain intensity): P = NS; ES: d = 0.32 Neither meditation nor WLC was effective in improving chronic low back pain. 
WLC 18 (5%) ND SF-36 Pain Subscale (pain): P = NS; ES: d = 0.16 
 Esmer [35] 40, Failed back surgery syndrome MBSR 19 (21%) 12 hours/8 weeks VAS (pain): P < 0.021 at wk 12; P = Sig at FU; ES: d = 1.02 MBSR is more effective than WLC in reducing pain associated with failed back surgery syndrome.  
WLC 21 (24%) ND 
 Ehrlich [32]* 579, Chronic low back pain Alexander technique (6 tx) 579 (20%) ND Von Korff Scale (pain): P = Sig (Alexander technique 24, exercise/control) at month 12 Both 6 lessons and 24 lessons with Alexander Technique, followed by exercise, are equally effective in treating chronic back pain.  
Alexander technique (24 tx) ND 
Massage ND 
Exercise ND 
Normal care ND 
 Wong [36] 100, Chronic pain MBSR 100 (ND) ND NRS (pain intensity): P = Sig** (both groups) at mo 6; P = NS Both MBSR and the education program are equally effective in improving chronic pain intensity.  
Education ND 
 Carson [33] 43, Chronic low back pain Loving-kindness meditation 43 (ND) 12 hours/8 weeks MPQ (pain intensity): P = Sig** (meditation); P = NS** (UC); ES: d = 0.42 A meditation program is effective in lowering chronic low back pain scores.  
UC ND/8 weeks 
BPI (usual pain, worst pain): P < 0.01** (meditation, usual pain); P = 0.05** (meditation, worst pain); P = ND; ES: d = 0.42 
 Plews-Ogan [37] 30, Musculoskeletal pain MBSR 10 (30%) 12 hours/8 weeks NRS (pain sensation and unpleasantness): P = Sig (massage, unpleasantness) at FU; P = NS** (MBSR, SC); P = NS MBSR is not effective for reducing musculoskeletal pain; however, massage is more effective than SC for reducing musculoskeletal pain.  
Massage 10 (10%) 8 hours/8 weeks 
SC 10 (20%) ND 
 Teixeira [38] 22, Diabetic neuropathy Meditation 11 (9%) 1 hour/1 day NPS (pain intensity): P = NS** at PT ES: d = 0.16 Neither mindfulness meditation nor attention-placebo effectively reduced pain associated with diabetic neuropathy.  
Attention-placebo 11 (9%) 1 hour/1 day 
Relaxation (N = 22) 
 Stenstrom [54] 54, Inflammatory rheumatic disease PMR 27 (0%) ND/12 months Nottingham Health Profile Pain Subscale (pain): P = NS at PT PMR shows minor improvements in the reduction of pain; no differences between groups noted. 
DMT 27 (0%) ND/12 months 
AIMS2 Pain Impact Subscale (pain): P < 0.05** (relaxation), P = NS at PT 
 Mehling [52] 36, Chronic low back pain Breathing 18 (11%) 9 hours/6 weeks VAS (pain intensity): P < 0.005** (both groups) at PT; P < 0.005** (both groups), P = NS at FU Both breath therapy and physical therapy were equally effective in reducing pain and disability associated with low back pain. 
PT 18 (33%) 9 hours/6 weeks 
SF-36 (bodily pain): P < 0.005** (both groups) at PT; P < 0.005** (both groups), P = NS at FU 
 Larsson [55] 41, Chronic headaches TAR 14 (14%) 8.25 hours/ND Headache Activity (headache activity): P < 0.05e (TAR/SM), P < 0.05e (SHR/SM) at PT and post-booster; P < 0.01d (SHR) over time; P < 0.01d (TAR) at FU; P = NSe (TAR/SHR) Both therapist and self-help relaxation are equally more effective than no treatment for reducing chronic headache pain. 
SHR 16 (13%) ND/ND 
Self-monitoring (SM) 11 (9%) ND 
 Poole [51] 234, Chronic low back pain Relaxation 82 (30%) 6 hours/6 weeks SF-36 Pain Subscale (pain): P < .0005** (all groups) over time; P = NS Relaxation, usual care, and reflexology are all equally effective in reducing chronic low back pain. 
UC 75 (43%) ND 
Reflexology 77 (16%) 6 hours/6 weeks 
VAS (pain): P = NS** 
 Anderson [57] 59, Cancer pain Relaxation 16 (63%) 3.3 hours/2 weeks BPI (pain): P < 0.05 (WLC/all groups, worst pain) at wk 7; P < 0.05** (PMD, WLC, pain severity) at PT; P < 0.05** (positive mood, WLC, average pain) at PT Distraction and WLC were equally effective in improving pain severity, while positive mood and WLC were equally effective in improving average pain scores. Furthermore, both relaxation and distraction groups reported immediate posttreatment pain reduction. 
PMD 16 (44%) 3.3 hours/2 weeks 
Distraction 13 (46%) 3.3 hours/2 weeks 
WLC 14 (43%) ND 
Pain Intensity Rating (pain): P < 0.03** (relaxation, PMD) at PT 
 Boyce [56] 105, Irritable bowel syndrome Relaxation 36 (64%) 4 hours/8 weeks SF-36 (bodily pain): P < 0.01** (all groups) over time; P < 0.05 (UC) over time All groups were equally effective in treating pain associated with irritable bowel syndrome. 
CBT 35 (49%) 8 hours/8 weeks 
UC 34 (38%) 0.75 hours + 190.4 g psyllium hus/ND 
 Trautmann [49] 65, Migraine, tension headache or combined migraine/tension headache Applied relaxation 22 (14%) ND/6 weeks Headache Diary (headache intensity): P = NS**; ES: d = 0.0 (CBT), d = −0.27 (AR), d = −0.11 (EDU) None of the groups (applied relaxation, education, cognitive behavioral therapy) are effective for reducing intensity of recurrent headache pain. 
Education 19 (47%) ND/6 weeks 
CBT 24 (54%) ND/6 weeks 
 Hammond [50] 183, Fibromyalgia Relaxation 86 (28%) 10 hours/10 weeks FIQ (pain): P = NS** Neither the relaxation nor the patient education are effective in reducing fibromyalgia pain. 
Education 97 (27%) 20 hours/10 weeks 
 Gustavsson [53] 37, Long-lasting neck pain Applied relaxation 18 (11%) 10.5 hours/7 weeks Ordinal Scale of Pain (pain intensity): P = NS** Neither the relaxation group nor treatment as usual group effectively reduced neck pain. 
UC 19 (11%) ND 
 Wahlund [60] 122, Temporo-mandibular disorders Relaxation 41 (17%) ND/ND VAS (pain): P < 0.01 (occlusal appliance/ brief information); P = NS (relaxation/occlusal appliance); P = ND** (relaxation/brief information) Occlusal appliance is more effective than brief information training in the reduction of pain intensity associated with temporomandibular disorders; no significant differences between the occlusal appliance and the relaxation training group or relaxation and brief information groups.  
Occlusal appliance 42 (12%) ND 
Brief information 39 (0%) 0.5 hours/1 day 
 Larsson [65] 48, Tension headache Relaxation 31 (0%) ND/5 weeks Headache Index (headache parameters): P < 0.05(peak intensity, headache frequency, headache free days), P = NS (headache duration) at PT Relaxation training program is more effective than WLC in reducing tension headache pain.  
WLC 17 (0%) ND 
 Loew [64] 54, Tension headache EFR 27 (11%) 0.75 hours/1 day Standardized Pain Diary (pain intensity): P = 0.003(intense pain), P = 0.03(medium pain) at PT EFR is more effective than an unspecified intervention in reducing tension headache pain intensity.  
Unspecified intervention 27 (56%) 0.75 hours/1 day 
 Larsson [67] 26, Chronic tension-type headache Relaxation 13 (0%) 4.2 hours/5 weeks Headache Activity (headache): P < 0.05 School-based, nurse-administered relaxation training program is more effective than no treatment in reducing chronic tension-type headaches in school children.  
NT 13 (0%) ND 
 Larsson [66] 32, Chronic headaches Relaxation training 12 (9%) 4.2 hours/5 weeks Headache Activity (headache parameters): P = NS (all groups, headache intensity); P = Sig (relaxation/information contact, headache sum); P = Sig (relaxation/NT, headache sum) at PT; P = NS (headache sum score) at FU Relaxation is more effective than information contact and no treatment in reducing weekly headache intensity at end of treatment; however, no differences were noted at follow up.  
Information contact 13 (0%) ND/ND 
NT 7 (0%) ND 
 Thorsell [61] 115, Chronic pain Applied relaxation 61 (46%) 3 hours/2 days OMPQ (pain intensity): P = NS** (applied relaxation) at PT, months 6, 12; P < 0.05** (ACT) at PT, month 6; P = ND; ES: d = −0.37 (ACT at PT), d = −0.47 (ACT at month 12) Applied relaxation is not as effective as ACT in treating chronic pain symptoms.  
ACT 54 (43%) 3 hours/2 days 
 McGrath [62] 99, Migraine Relaxation training 32 (38%) 6 hours/6 weeks Headache Diary (headache): P < 0.05** (all groups) over time; P = NS Both relaxation and placebo treatments are equally effective in reducing migraine pain.  
Placebo 37 (43%) 6 hours/6 weeks 
Own best efforts 30 (30%) ND 
 Blanchard [69] 39, Tension headache PMR + home practice (PMR+) 39 (15%) ND/8 weeks Headache Diary (headache): P = 0.005** (PMR+), P = 0.04** (PMR), P = Sig (PMR+, PMR/WLC), P = NS (PMR+/PMR) at PT Both PMR + home practice and PMR are equally more effective than WLC in reducing headache intensity.  
PMR ND/8 weeks 
WLC ND 
 Barsky [59] 168, Rheumatoid arthritis Relaxation response 44 (27%) 6.7 hours/ND Rheumatoid Arthritis Symptom Questionnaire (pain): P < 0.001** (all groups) over time, month 6; P = Sig** (education), P = NS** (CBT, relaxation), P = NS (all groups) at month 12 ES: d = 0.26–0.35 (at PT) Relaxation, arthritis education, and CBT are all equally effective in reducing pain.  
Arthritis education 56 (21%) 6.7 hours/ND 
CBT 68 (16%) 12 hours/ND 
 Linton [58] 15, Chronic pain Applied relaxation 15 (0%) 6 hours/4 weeks 5-Point Likert Scale (pain intensity): P = Sig (applied relaxation/WLC) at PT; P = Sig** (all groups) over time Although all groups were effective in reducing pain, applied relaxation seems to be more effective than applied relaxation + operant conditioning and WLC.  
Applied relaxation + operant conditioning ND/4 weeks 
WLC ND 
 Funch [68] 57, Chronic temporomandibular joint pain Relaxation 30 (0%) 1 hour/ND 6-Point Likert Scale (pain rating): P = NS** Neither relaxation nor biofeedback is effective in reducing chronic temporomandibular joint pain.  
Biofeedback 27 (0%) 0.2 hours/1 day 
 Lundgren [63] 68, Rheumatoid arthritis Relaxation training 37 (11%) 10 hours/10 weeks VAS (pain): P = NS** Neither muscle relaxation training nor a no-treatment control group are effective in reducing pain associated with rheumatoid arthritis.  
NT 31 (13%) ND 
 Gay [24] 41, Osteoarthritis pain Relaxation 14 (7%) 4 hours/8 weeks VAS (pain): P < 0.0004 (hypnosis/relaxation, hypnosis/WLC), P = NS (relaxation/WLC) at week 4; P < 0.003 (hypnosis/WLC, relaxation/WLC), P = NS (hypnosis/relaxation) at PT; P < 0.004 (hypnosis/WLC), P = NS (hypnosis/relaxation, relaxation/WLC) at month 3, P = NS (all groups) at month 6 Hypnosis is more effective than both relaxation and WLC in reducing osteoarthritis pain at 4 weeks; however, both hypnosis and relaxation are equally more effective than WLC at 8 weeks. None of the groups were effective at 6 months.  
Hypnosis 14 (7%) 4 hours/8 weeks 
WLC 13 (23%) ND 
Biofeedback (N = 13) 
 Kapitza [76] 42, Chronic low back pain Respiratory feedback 21 (0%) 7.5 hours/15 days Pain Diary (pain): P < 0.02** (respiratory biofeedback, pain at rest/during activity), P = 0.014** (placebo biofeedback, pain during activity) at month 3; P = NS** (placebo biofeedback, pain at rest), P = NS Respiratory biofeedback is more effective than placebo biofeedback in reducing pain 3 months post intervention. 
Placebo biofeedback 21 (0%) 7.5 hours/15 days 
 Scharff [80] 36, Migraine in children Handwarming biofeedback 13 (0%) 4.5 hours/6 weeks Headache Index (headache intensity): P = Sig** (all groups), P = NS (all groups) at month 12 Both handwarming biofeedback and handcooling biofeedback seem to be equally effective in reducing headache intensity over time. 
Handcooling biofeedback 11 (9%) 4.5 hours/6 weeks 
WLC 12 (8%) ND 
 Bruhn [82] 28, Chronic muscle contraction headache EMG biofeedback 14 (7%) 5.3 hours/8 weeks Headache Diary (headache intensity): P < 0.01** (biofeedback) at last 2 weeks of therapy; P = ND** (UC); P = ND EMG biofeedback therapy is effective in reducing severe muscle contraction headaches at posttest; no between group differences were reported.  
UC 14 (29%) ND 
 Kayiran [83] 40, Fibromyalgia Neurofeedback sensory motor training 20 (10%) 10 hours/4 weeks VAS (pain intensity): P < 0.05 at every PT visit Neurofeedback Sensory Motor Training is more effective than escitalopram in reducing pain associated with fibromyalgia.  
Escitalopram 20 (10%) 560 mg/8 weeks 
 Babu [84] 30, Fibromyalgia EMG biofeedback 15 (0%) 4.5 hours/6 days VAS (pain): P = 0.000 EMG biofeedback is more effective than sham biofeedback in reducing fibromyalgia pain.  
Sham biofeedback 15 (0%) 4.5 hours/6 days 
 Nelson [85] 42, Fibromyalgia LENS 21 (24%) ND/ND NRS (pain intensity): P < 0.001** (LENS, pain intensity of past 24 h); P = NS** (placebo, pain intensity of past 24 h); P = ND** (both groups, current pain intensity); P = ND LENS treatment is more effective than placebo biofeedback at alleviating fibromyalgia pain.  
Placebo biofeedback 21 (24%) ND/ND 
 Ma [86] 60, Neck and/or shoulder pain Biofeedback 15 (33%) 24 hours/6 weeks VAS (pain): P < 0.04** (biofeedback, active exercise, PassTx), P = NS** (education), P = Sig (education/other groups), P = NS (active exercise/ PassTx) at PT; P = 0.00 (biofeedback/other groups) at PT, month 6; Biofeedback was more effective than active exercise, passive treatment, and an education group in reducing neck and shoulder pain.  
P < 0.02 (active exercise/ PassTx, education), P = NS (PassTx /education) at month 6 
Active exercise ND 57.3 hours/6 weeks 
PassTx ND 7 hours/6 weeks 
Education book 15 (40%) ND/6 weeks 
 Simon [87] 30, Chronic constipation EMG biofeedback 15 (0%) 6 hours/1 month 10-Point Likert Scale (pain): P < 0.01** (biofeedback) at FU; P = NS** (counseling); P = Sig EMG biofeedback is more effective than counseling for reducing pain associated with chronic constipation in elderly patients.  
Counseling 15 (0%) 6 hours/1 month 
 Newton-John [78] 44, Chronic low back pain EMG biofeedback 16 (38%) 8 hours/4 wks Pain Diary (pain severity): P < 0.007 (biofeedback/WLC, CBT/WLC); P = NS (biofeedback/CBT) Both CBT and EMG biofeedback were equally more effective than WLC in reducing self-monitored chronic low back pain.  
CBT 16 (19%) 8 hours/4 weeks 
WLC 12 (ND) ND 
 Bohm-Starke [88] 35, Provoked vestibulodynia Surface EMG biofeedback 17 (0%) 40 hours/4 months VAS (pain intensity): P = NS** Both surface EMG biofeedback and topical lidocaine were equally effective in decreasing gastrointestinal tract, shoulder, joint, and back pain symptoms at 6 months post intervention.  
SF-36 Pain Subscale (bodily pain): P = NS** 
Topical lidocaine 18 (0%) ND/4 months 
Subjective Outcome and Bodily Pain (pain): P < 0.01**(gastrointestinal tract, joint, shoulder, back pain), P = NS at FU 
 Holroyd [81] 43, Tension headache Decrease/High 43 (12%) 5 hours/12 weeks Headache Recordings (headache intensity): P < 0.05** (Decrease/High, Increase/High, Increase/Moderate); P = NS All EMG biofeedback groups were equally more effective than the decrease/moderate group in improving tension headache pain scores.  
Decrease/Moderate 5 hours/12 weeks 
Increase/High 5 hours/12 weeks 
Increase/Moderate 5 hours/12 weeks 
 Nouwen [77] 20, Chronic low back pain EMG biofeedback 10 (0%) 10 hours/3 weeks Back Pain Log (pain): P = NS** Neither EMG biofeedback nor WLC are effective in alleviating low back pain.  
WLC 10 (0%) MD 
 Bush [79] 72, Chronic low back pain Biofeedback 23 (9%) 4 hours/ND Daily Low Back Pain Record (pain severity): P = NS (all groups) Neither EMG biofeedback nor placebo is effective in treating chronic low back pain in a nonhospitalized population.  
Placebo 24 (4%) 4 hours/ND 
WLC 25 (0%) ND 
MPQ—PPI (present pain severity): P = NS (all groups) at PT 
Guided Imagery/Self-Hypnosis (N = 6) 
 Menzies [95] 48, Fibromyalgia GI 24 (0%) ND/10 weeks SF-MPQ PPI Subscale (present pain intensity): P = NS** Neither guided imagery nor usual care were effective in reducing fibromyalgia pain. 
UC 24 (0%) ND/10 weeks 
SF- MPQ VAS Subscale (pain): P = NS** 
 Fors [96] 58, Fibromyalgia GI 17 (0%) 0.5 hours/1 day VAS (pain): P < 0.001** (GI and patient education) at PT; P < 0.05 (GI/pain-related talk, patient education/pain-related talk); P = NS (GI/patient education); P = NS** (pain-related talk) Both guided imagery and patient education are equally more effective than a pain-related talk group in reducing short-term fibromyalgia pain.  
Pain-related talk 19 (0%) 0.5 hours/1 day 
Patient education 22 (0%) 0.5 hours/1 day 
 van Tilburg [97] 34, Abdominal pain GI + SMC 19 (16%) ND/8 weeks Abdominal Pain Index (parent report of pain intensity and pain severity): P < 0.05** (GI + SMC), P = ND at PT, FU Guided imagery plus standard medical care is effective in reducing pain associated with the abdomen.  
SMC 15 (0%) ND 
 Patterson [98] 21, Physical trauma injuries VRH 21 (22%) 8 hours/1 day GRS (pain): P < 0.05** (VRH, NT, pain intensity, pain unpleasantness), P < 0.05** (VRH, least pain intensity in past 8h), P < 0.05** (NT, least pain intensity in past 8h), P = NS at PT VRH is effective in reducing pain intensity and unpleasantness associated with physical trauma injuries, whereas the control group reported increases in these areas; no significant between group differences were noted.  
Virtual reality/NT ND 
 Carrico [99] 30, Insterstitial cystitis GI 15 (27%) 46.7 hours/8 weeks VAS (pain): P = 0.027** (GI), P = NS** (WLC), P = NS at PT Guided imagery is effective in reducing insterstitial cystitis pain, whereas the control group indicated no changes; no significant difference between groups were noted.  
WLC 15 (7%) 46.7 hours/8 weeks 
 Lewandowski [100] 44, Chronic pain GI 22 (5%) 21 minutes/3 days VAS (pain intensity): P < 0.05 at day 4, 5; P = NS at day 2, 3 Guided imagery is effective in reducing chronic pain.  
WLC 22 (5%) ND 
Autogenic Training (N = 2) 
 Asbury [23] 53, Cardiac syndrome x AT 27 (15%) 12 hours/8 weeks Symptom Monitoring Diary (symptom severity): P < 0.001** (AT), P = NS at PT Autogenic training is effective in reducing cardiac symptom pain symptom severity; no between group differences noted.  
Symptom monitoring 26 (4%) ND 
 VanDyck [107] 71, Chronic tension headaches AT 71 (23%) 10 hours/7 weeks Headache Index (pain intensity): P < 0.05** (AT, hypnotic imagery) over time; ES: d = 0.45 Both autogenic training and future-oriented hypnotic imagery were equally effective in reducing chronic pain.  
Future-oriented hypnotic imagery 10 hours/7 weeks 

ACoT = Acceptance and Commitment Therapy; AT = autogenic training; AIMS2 = Arthritis Impact Measurement Scales 2; ASA = Affect Self-Awareness; BPI = Brief Pain Inventory; CBST = cognitive behavioral skills training; CBT = cognitive behavioral therapy; DMT = Dynamic Muscle Training; EFR = Elements of Functional Relaxation; EMG = electromyography; ES = effect size; GRS = Graphic Rating Scale; IC-SIPI = Interstitial Cystitis Symptom Index and Problem Index; LENS = low energy neurofeedback system; MBSR = Mindfulness-Based Stress Reduction; MIP = Multidisciplinary Intervention Program; MPQ = McGill Pain Questionnaire; NDI = Neck Disability Index; NAT = no adjunct treatment; NPS = Neuropathic Pain Scale; ND = not described; NS = not significant; NT = no treatment; OA = osteoarthritis; OMPQ = Orebro Musculoskeletal Pain Questionnaire; PassTx = passive treatment; PMD = positive mood distraction; PMR = progressive muscle relaxation; PPI = present pain intensity; PPS = Pain Perception Scale; PT = physical therapy; SC = standard care; SF-36 = Medical Outcomes Study Short Form; SGT = structured group social support therapy; SMUBT = Single Motor Unit Biofeedback Training; SF-MPQ = Short-Form McGill Pain Questionnaire; SF-PQ = Short-Form Pain Questionnaire; SHR = Self-Help Relaxation; Sig = significant but P value not given; SMC = standard medical care; SGT = structured group social support therapy; TAR = Therapist Assisted Relaxation; TENS = transcutaneous electrical nerve stimulation; TT = therapeutic touch; TX = treatment; UC = usual care; VRH = virtual reality hypnosis; WLC = wait list control.

*

Subset of study results were also reported in Hollinghurst S, Sharp D, Ballard K, et al. Randomised controlled trial of Alexander technique lessons, exercise, and massage (ATEAM) for chronic and recurrent back pain: Economic evaluation. BMJ. 2008;337:a2656; all relevant results from both studies reported here.

Result reporting for two interventions: Outcome Name (construct measured): P value (group or groups that showed significance) at time point, if reported by the article's authors.

Result reporting for two or more interventions: Outcome Name (construct measured): P value (group 1/group 2) at time point, if reported by the article's authors. Note that groups compared with each other are listed following the P value.

Authors report power achieved.

Authors report power not achieved.

Numbers reflect overall sample.

**

Within groups.

Between groups.

Of the nine high-quality (+) studies [49–57], one study [54] found that progressive muscle relaxation (PMR) resulted in minor improvements in inflammatory rheumatic disease, while another study [55] found that both therapist-assisted and self-help relaxation were equally more effective than no treatment in reducing chronic headache pain. Breath therapy and relaxation were found to be as effective as physical therapy [52] and other therapies (i.e., routine/usual care [51,56], reflexology [51], positive mood [57], distraction [57], WLC [57], and cognitive behavioral therapy [CBT][56], respectively) for the treatment of a variety of conditions, including chronic low back pain [51,52], cancer pain [57], and irritable bowel syndrome [56]. Neither relaxation nor the controls (e.g., education, CBT, usual care) were reported to be effective for reducing pain associated with conditions such as recurrent headaches [49], fibromyalgia [50], and neck pain [53].

Dosages for this subset of studies were wide, ranging from 3.3 hours over 2 weeks to 10 hours over 10 weeks; however, many studies seemed to center around 8–10 hours over a set amount of time [50,52,53,55]. Three studies [49,54,55] did not include full descriptions of dosages, thus total dosages could not be determined for these studies. Safety was also not well reported, with only one study [52] mentioning adverse events, citing uncomfortable memories.

The remaining 13 studies were scored as poor quality (−) according to SIGN 50 criteria, with the majority reporting favorable effects, especially for headache treatment. For example, relaxation was found to be more effective than no treatment [66,67] and WLC [65] for reducing chronic headaches. Similarly, “elements of a functional relaxation program” was reported to be more effective than an unspecified intervention technique in reducing tension headache pain [64]. Relaxation was also found to be comparable to several interventions; relaxation training and PMR were shown to be as effective as a placebo treatment [62] and a WLC [69], respectively, for the treatment of headaches. Mixed results were found for the treatment of rheumatoid arthritis pain; while one study reported that relaxation response was as effective as arthritis education and CBT [59], another [63] showed that relaxation was not effective at all. Contrasting results were also found for the use of applied relaxation for chronic pain treatment as one study reported applied relaxation was more effective than applied relaxation + operant conditioning and WLC [58], while another study [61] reported that acceptance and commitment therapy was more effective than applied relaxation. The remaining two poor-quality studies did not show any positive effects; one study [24] found that relaxation was not as effective as hypnosis in treating osteoarthritis pain. The other [60] showed that the occlusal mouth guard appliance is more effective than brief information training in the reduction of pain intensity associated with temporomandibular disorders; no significant differences between the occlusal appliance and relaxation training were found.

Dosages were reported to be as low as 0.75 hours over 1 day [64] and as high as 10 hours over 10 weeks [63] for this subset of studies. Higher quality studies tended to feature higher dosages of 8–10 hours over a certain timeframe, while lower quality studies generally reported lower dosages, closer to 3–6 hours over the study period. Five studies [59,60,65,68,69], moreover, did not provide full dosaging details. None of the 13 poor-quality (−) studies reported or mentioned adverse events.

GRADE Analysis

Despite the lack of available safety data for relaxation therapies, these therapies are rarely associated with adverse events [70], and are generally considered safe for healthy populations [47]. Some relaxation techniques, however, may cause or worsen symptoms of conditions such as epilepsy and/or certain psychiatric disorders, especially in those with a history of abuse or trauma [71]. According to the only study included in this review that reported adverse events, relaxation appears to be relatively safe; however, because only one out of 22 studies mentioned adverse events at all, the overall safety of this literature pool remains uncertain.

In addition to the lack of safety reporting, this subset of studies suffered from several methodological flaws (i.e., small sample sizes, lack of information regarding randomization and concealment, high dropout rates) that resulted in decreased confidence in the reliability of the reported results, despite the favorable effects that the majority of the studies had shown for relaxation. Only three studies [49,59,61], moreover, reported effect sizes for pain intensity/severity, citing none to very small effects. Given the lack of information regarding effect sizes and safety reporting, as well as the methodological flaws of the studies, there was agreement among the SMEs that no recommendation could be made for the usage of relaxation to treat chronic pain and that further research is likely to have an important impact on the confidence in the estimate of the effect (see Table 0003). Based on the heterogeneity of relaxation techniques and methods as well as inconsistent dosaging in this literature pool, future research should not only focus on which relaxation modalities are most effective, but also on what the adequate amount of dosing is.

Table 3

GRADE [22] analysis of mind–body therapy studies

Modality Number of Participants Completed (Number of Studies) Confidence in the Estimate of the Effect of the Intervention* Magnitude of the Estimate of the Effect Size (# of Studies Reported ES) Overall Safety Reported Studies Safety (# Studies Reporting AE) Strength of the Recommendation 
Mindfulness/Meditation 1,209 (11) Small (5) +2 (4) None 
Relaxation 1,603 (22) None (3) +2 (1) None 
Biofeedback  455 (13) NR +2 (1) None 
Guided imagery and self-hypnosis  235 (6) NR +2 (1) None 
Autogenic training  152 (2) Small (1) 0 (0) None 
Modality Number of Participants Completed (Number of Studies) Confidence in the Estimate of the Effect of the Intervention* Magnitude of the Estimate of the Effect Size (# of Studies Reported ES) Overall Safety Reported Studies Safety (# Studies Reporting AE) Strength of the Recommendation 
Mindfulness/Meditation 1,209 (11) Small (5) +2 (4) None 
Relaxation 1,603 (22) None (3) +2 (1) None 
Biofeedback  455 (13) NR +2 (1) None 
Guided imagery and self-hypnosis  235 (6) NR +2 (1) None 
Autogenic training  152 (2) Small (1) 0 (0) None 

AE = adverse events; ES = effect size; NR = not reported.

*

Refers to the likelihood that future research will change the confidence in the estimate of the effect; includes four possible levels of confidence based on the GRADE working group approach: A (High); B (Moderate); C (Low); D (Very Low).

Average effect size, as reported by Cohen's d, of studies that reported this information was categorized as none (d < 0.02), small (d = 0.2–0.5), moderate (d = 0.51–0.8), and large (d > 0.8).

Based on overall study sample; reflects the frequency and severity of AEs and categorized into one of the following scores: (+2), appears safe with infrequent AEs; (+1), appears relatively safe, with frequent, nonserious AEs; (0), safety either not reported by at least 50% of studies, or not well understood/conflicting; (1), appears to have safety concerns including infrequent, serious AEs; (2), appears to have serious safety concerns, including frequent and serious AEs.

Uses same criteria as overall safety score, but based only on those studies that reported safety.

Strong recommendation in favor of or against = very certain that benefits do, or do not, outweigh risks and burdens; no recommendation = no recommendations can be made; or weak recommendation in favor of or against = benefits and risks and burdens are finely balanced, or appreciable uncertainty exists about the magnitude of benefits and risks.

Biofeedback

Biofeedback is a mind–body technique in which participants learn to cultivate awareness about their unhealthy mental patterns and habits, and to improve their health by controlling bodily functions (e.g., breathing rate, heart rate, blood pressure). During biofeedback treatments, participants are connected to electrical sensors, which measure bodily functions. Results are displayed on a monitor, and this feedback allows them to make subtle changes, such as relaxing particular muscles, to achieve desired results. Tones or sounds may be used to let participants know when they have achieved a certain goal or state. Biofeedback can be used as a self-management tool to treat a variety of mental health issues, including anxiety or stress as well as asthma [72], heart problems [73], pain [74], irritable bowel syndrome, and high blood pressure [75].

Results

Two high-quality (+) and 11 poor-quality (−) studies, consisting of a total of 455 total participants, investigated biofeedback as a treatment for a variety of chronic pain conditions, such as chronic low back pain [76–79], migraines/headaches [80–82], fibromyalgia [83–85], neck and/or shoulder pain [86], chronic constipation [87], and provoked vestibulodynia [88] (see Table 0002 for full description of studies). Biofeedback dosages were fairly wide ranging, with dosages of anywhere from 7.5 hours over 15 days to 40 hours over 4 months.

Of the two high-quality (+) studies, one study [76] found that 7.5 hours of respiratory biofeedback over 15 days was more effective than placebo biofeedback for treating chronic low back pain, while the second study [80] found that 24 hours of either handwarming and handcooling biofeedback over 6 weeks, compared with WLC, were both equally effective in relieving migraine pain. Neither of these studies reported on adverse events.

The majority (N = 11) of the biofeedback studies were of poor quality (−), with several (N = 9) reporting favorable results. Three studies compared biofeedback to some type of pharmaceutical agent. Of these, two studies found that electromyography (EMG) biofeedback [82], compared with physical therapy and/or pharmacological treatment, and neurofeedback sensory motor training [83], compared with escitalopram, were more effective than the controls in treating chronic muscle contraction headaches and fibromyalgia, respectively. The third study [88] demonstrated that surface EMG biofeedback and topical lidocaine were equally effective in reducing pain associated with provoked vestibulodynia. Two studies [84,85] reported that biofeedback and Low Energy Neurofeedback System (LENS) were more effective than sham/placebo biofeedback for reducing fibromyalgia pain. Biofeedback, moreover, was more effective than active exercise, passive treatment, and an educational book for treating neck and/or shoulder pain [86], and more effective than counseling for treating chronic constipation [87]. When treating chronic low back pain, however, both EMG biofeedback and CBT were found to be equally effective [78]. In one study, authors manipulated the EMG contingency (decrease/increase) and performance feedback (high success/moderate success) when investigating the use of biofeedback for tension headaches; all biofeedback groups (i.e., decrease EMG contingency/high success, increase contingency/high success, increase contingency/moderate success) were equally more effective than the decrease contingency/moderate success group [81]. Lastly, the remaining two poor-quality studies [77,79] were not effective chronic low back pain treatments.

Dosaging of the poor quality studies was wide ranging, with studies reporting dosages as low as 4.5 hours over 6 days [84], to as high as 40 hours over 4 months [88]; 2 studies [79,85] did not include enough detail about dosaging to report on. Only 1 out of the 11 [85] poor-quality studies reported on adverse events, mentioning that none occurred.

GRADE Analysis

Occasional reports of dizziness, anxiety, or disorientation have been documented for biofeedback; however, biofeedback is considered to be a generally safe technique [89]. Out of all 13 biofeedback studies assessed in this review, only one study [85] mentioned safety documenting that no adverse events occurred. Because the majority of studies did not report or even mention safety, however, the SMEs were not able to adequately comment on the safety of biofeedback without more information.

The majority of studies had serious methodological limitations surrounding dropout rates, randomization methods, baseline similarities of intervention groups, and lack of safety and effect size reporting that decreased confidence in the reliability of these studies' results. The authors agreed that further research is very likely to have an important impact on the confidence in the estimate of the effect. Based on the current state of the evidence, no recommendation was made by the SMEs for the use of biofeedback as a self-management tool for chronic pain symptoms (see Table 0003).

Guided Imagery and Self-Hypnosis

Guided imagery is a technique in which the patient is given mental imagery suggestions, either in-person, by a trained practitioner, or through self-administered cassette tapes, mp3s, or compact discs (CDs). Sessions are often combined with other approaches, typically beginning with breathing and relaxing techniques before progressing with mental imagery specifically targeted at the patient's problem, and guiding the patient's imagination toward a more relaxed and focused state. Guided imagery is often used to stimulate healing [90], manage pain [91], and promote relaxation, thereby lowering blood pressure [92] and reducing other stress-related problems.

Hypnosis refers to a trance-like state, typically delivered by a hypnotist, in which individuals have heightened focus and concentration. Hypnosis is usually induced by a series of preliminary instructions and suggestions consisting of verbal repetition and mental images. While it can provide a variety of medical and therapeutic effects, it is most commonly used in the treatment of pain [93] and anxiety [94]. While hypnosis is mostly reliant on a practitioner, it can be self-administered through cassette tapes, mp3s, or CDs, and, as such, only self-hypnosis was included in this review.

For purposes of this review, the authors grouped guided imagery and self-hypnosis into one of group of modalities due to their similar techniques.

Results

Six studies, involving 235 total participants, investigated the use of guided imagery and hypnosis for the management of many pain conditions, including fibromyalgia [95,96], abdominal pain [97], physical trauma injuries [98], interstitial cystitis [99], and chronic pain [100] (see Table 0002 for full description of studies). Dosage ranged from 21 minutes over 3 days to 47 hours over 8 weeks.

The sole high-quality (+) study [95] comparing 10 weeks of guided imagery to usual care found that neither intervention was effective in reducing fibromyalgia pain. Additionally, adverse events were not described in the report.

The remaining five poor-quality (−) studies included fibromyalgia [96], abdominal pain [97], physical trauma injuries [98], interstitial cystitis [99], and chronic pain [100] populations. One study [96] reported that both guided imagery and patient education were equally more effective than a pain-related talk group in reducing fibromyalgia pain. The remaining four studies all reported that guided imagery or self-hypnosis (i.e., virtual reality with posthypnotic suggestions) was more effective than inactive controls (i.e., SMC [97], no treatment [98], WLC [80,81]). Dosages for this subset of studies ranged from as little as 21 minutes over 3 days to 47 hours over 8 weeks; 1 study [97], moreover, reported dosage of 40 sessions over 8 weeks, but did not describe the length of the sessions. Only one study [97] reported on adverse events, reporting mild transient headaches, while the remaining studies did not mention or describe adverse events at all.

GRADE Analysis

Although safety is often not reported among guided imagery or self-hypnosis studies [101,102], they are both generally considered to be safe [13]. There have been reports, however, that such practices may cause or worsen symptoms in people with certain psychiatric or heart conditions, epilepsy, history of abuse, or trauma [103]. Based on the one study [97] that commented on adverse events, and reported that no such events occurred, guided imagery and self-hypnosis appear to be safe. Because the remaining studies, however, did not even mention adverse events, the overall safety of this intervention is still not well understood, and thus, more information regarding safety is needed for the authors to make sound recommendations for guided imagery and self-hypnosis (see Table 0003).

Because the majority of studies seemed underpowered, of poor quality, and did not report effect sizes, any estimate of an effect is very uncertain given this current evidence base. Pairing these flaws with the lack of safety reporting, the SMEs agreed that no recommendation for the usage of guided imagery/self-hypnosis for treatment of chronic pain symptoms could be made at this time.

Autogenic Training

Autogenic training is a relaxation technique developed in 1932 by Johannes Heinrich Schultz, which involves simple relaxation and body awareness exercises aimed at reducing the body's stress response in order to relax the body and begin self-healing. Standard autogenic training sessions focus on teaching participants' bodies to respond to verbal commands so that participants will eventually be able to “tell” their body to relax and control certain physiological responses (e.g., body temperature, heartbeat, blood pressure) on their own. Autogenic training is commonly used to treat stress disorders, pain, and anxiety [104–106].

Results

Two poor-quality (−) studies, with 152 total participants, studied the use of autogenic training for pain management (see Table 0002 for full description of studies). The first study [23] found that 12 hours of autogenic training over 8 weeks, compared with symptom monitoring control, was effective in reducing cardiac symptom pain severity associated with cardiac syndrome x. The second study [107] reported that both 10 hours of autogenic training over 7 weeks and the same amount of future-oriented hypnotic imagery were equally effective in reducing pain associated with chronic tension headaches. Neither of the two studies reported or mentioned adverse events.

GRADE Analysis

Although autogenic training presents no apparent risks [108], and systematic reviews have found no adverse events reported in the literature [109,110], neither of the two included studies described any adverse events, leaving the safety of autogenic training unknown. Both studies showed favorable effects of autogenic training, with one study reporting a small effect size (d = 0.45); however, both studies were poor quality, suffering from methodological flaws, low sample sizes, and complete lack of safety reporting. Any estimate of an effect is very uncertain, given the current evidence base for this self-management tool for pain. Because of these factors, the SMEs were unable to make any recommendation for autogenic training as a treatment for chronic pain symptoms, stating that more highly powered studies are needed in this area assessing pain management.

Discussion

Surveys of the most commonly used ACT-CIM modalities suggest that mind–body therapies are the most commonly used modality for chronic pain conditions. Mounting evidence is moving mind–body medicine toward greater acceptance within mainstream medicine [111]. Mind–body therapies that empower the patient and promote patient-centered care have been associated with improved patient satisfaction, better health outcomes and state of health, as well as reduced utilization of health care services. Based on the results of this current analysis, however, the authors were unable to make any strong recommendations for the use of any of the included mind–body therapies in self-managing chronic pain symptoms. The authors agreed further research is very likely to influence their understanding of the effect of mindfulness/meditation, relaxation (including breathing exercises), and biofeedback, and were uncertain about the effect of guided imagery, self-hypnosis, and autogenic training. Consequently, the authors believe that more sound research across all these modalities needs to be conducted before any recommendations can be made.

Indeed, this current subset of studies was low quality, due in large part to methodological design flaws, lack of safety, and effect size reporting and underpowered studies. In fact, despite a paucity of safety reporting in studies, mind–body practices are considered to be generally safe when practiced appropriately [18,112,113]. Of the 54 mind–body therapy studies included in the review, however, only 5 studies [30,31,52,85,97] reported adverse events, 3 [30,31,85] of which stating none occurred. This is a clear gap in the evidence base; until researchers consistently comment on and document any and all safety concerns, it will remain a challenge to promote these practices to patients for the self-management of chronic pain symptoms.

Furthermore, there were several modalities (i.e., faith healing, prayer, self-therapeutic touch, self-reiki, and mental healing) for which no evidence was found. Preliminary data, largely based on observational and anecdotal evidence, suggest that these modalities may be useful in the self-management of pain due to underlying mechanisms of action similar to other mind–body therapies as reported in their use for other conditions. The authors encourage future research to explore these therapies as potential self-management tools for pain in robust RCT settings.

Future studies should also provide consistent dosing (i.e., training and practice requirements) and meaningful control groups in order to accurately evaluate these modalities and achieve consistent and beneficial results. This is essential if effective replication is to take place in both future research and in implementation of ACT-CIM therapies determined to be effective in chronic pain management, or perhaps even prevention. Researchers should focus their efforts on performing higher powered, well-designed research on modalities which have shown promise in smaller, pilot studies in order to continue to build on previous efforts.

Lastly, recent reviews suggest that implementation of mind–body therapies could realize immediate and significant cost savings throughout our health care system [114,115]. Only two studies in this category included cost analyses. One study [55] revealed that the self-help relaxation condition was more cost-effective than the therapist-assisted relaxation groups. The second study [32] determined that exercise was the most cost-effective intervention compared with 6 or 24 Alexander technique sessions and massage. The authors recommend that more studies analyzing cost of mind–body modalities are needed, particularly those that analyze costs relative to normal care costs, in order to determine which self-help management therapies are most effective in preserving limited practitioner, organizational, governmental, and military resources. The authors encourage researchers to bring in health economists and their expertise at protocol development of clinical trials so that this data can be captured accurately in future studies.

Conclusions

Implementation of safe and effective ACT-CIM therapies, specifically mind–body therapies, as an essential part of a practical, holistic, integrative approach to the management of chronic pain, is important given the potential benefits (e.g., promotion of self-efficacy, relative low cost, ability to be self-directed) of these therapies; however, current research supporting such implementation is weak due to overall low quality of existing studies, inconclusive/mixed results, and lack of safety reporting. Although previous research promotes the effectiveness of these modalities, the authors strongly suggest that further well-designed, high-powered studies, aimed at answering unresolved questions posed by this review, are needed to determine their usefulness and applicability for integration into existing health care systems. Adherence to research guidelines for mind–body therapies, including consistent reporting of safety and effect size, is essential in order to be able to recommend implementation of these approaches which show promise in improving resiliency and well-being in active duty members, veterans, civilians, and their families. Studies that analyze cost of implementation compared with usual care are also essential to support cost versus benefit analysis for various therapies. These investigations should take into account decreased use of other clinical support systems, improvement in function, return to work, quality of life, and decrements in use of opioids and polypharmacy approaches to care.

Acknowledgments

The authors would like to acknowledge Ms. Lea Xenakis and Ms. Jennifer Smith for their help with conducting the review, as well as Ms. Viviane Enslein and Mr. John Bingham for helping prepare the manuscript.

The Active Self-Care Therapies for Pain (PACT) Working Group included the following individuals at the time of writing (see http://onlinelibrary.wiley.com/doi/10.1111/pme.12358/full for working group affiliations):

Chester C. Buckenmaier III, MD, COL, MC, US Army; Cindy Crawford, BA; Paul Crawford, MD, Lt Col, US Air Force; Roxana Delgado, PhD; Daniel Freilich, MD, CAPT, MC, USNR; Anita Hickey, MD, CAPT, MC, USN; Wayne B. Jonas, MD, LTC (Ret.), US Army; Courtney Lee, MA; Todd May, DO, CDR, USN; Richard P. Petri, MD, COL, MC, US Army; Eric B. Schoomaker, MD, PhD, LTG (Ret.), US Army; Christopher Spevak, MD, MPH, JD; Steven Swann, MD, COL (Ret.), US Army; Alexandra York, MS.

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99
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Disclosures: The authors report no conflicts of interest. The authors have not presented these data and information before in any journal or presentation and have no professional relationships with companies or manufacturers who will benefit from the results of this present study. This material is based upon work supported by the US Army Medical Research and Materiel Command under Award Nos. W81XWH-08-1-0615 and W81XWH-10-1-0938. Any opinions, findings, and conclusions or recommendations expressed in this material are those of the author(s) and should not be construed as an official Department of Defense, Department of the Army, or Uniformed Services University of the Health Sciences position, policy, or decision unless so designated by other documentation.