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Mindfulness Training for Chronic Non-malignant Pain Management: A Review of the Clinical Effectiveness, Cost-effectiveness and Guidelines

CADTH Rapid Response Report: Summary with Critical Appraisal

and .

Abbreviations

AGREE

Appraisal of Guidelines, Research and Evaluation

AMSTAR

A MeaSurement Tool to Assess Systematic Reviews

CINAHL

Cumulative Index to Nursing and Allied Health Literature

CRD

Centre for Reviews and Dissemination

DoD

Department of Defense

GRADE

Grading of Recommendations, Assessment, Development and Evaluation

HIT-6

Headache Impact Test-6

ICD

International Classification of Diseases

MBSR

Mindfulness-based Stress Reduction

MeSH

Medical Subject Headings

MIDAS

Migraine Disability Assessment

PRISMA

Preferred Reporting Items for Systematic Reviews and Meta-Analyses

RCT

Randomized Controlled Trial

SF-36

36-Item Short Form Survey

VA

Department of Veterans Affairs

Context and Policy Issues

Chronic pain is a pervasive health issue that adversely affects both the patient and society, including loss of productivity, decreased quality of life, and an increased burden on the health care system.14 The International Classification of Diseases (ICD) of the World Health Organization defines chronic pain as persistent or recurrent pain lasting longer than three months.5 Non-malignant (non-cancer) related types of chronic pain may include low back pain, osteoarthritis, rheumatoid arthritis, headache, neck pain, fibromyalgia, and irritable bowel syndrome.6 The prevalence of chronic pain is estimated to be 21% among the general Canadian population, a prevalence rate that has increased over time.2 Chronic pain has substantial economic implications and has been estimated to cost Canada over six billion dollars per year in direct health care costs and 37 billion per year in productivity costs (e.g., job loss, sick days).1,7,8

Given the prevalence and burden of chronic pain, a variety of treatment options have been explored to help patients manage their symptoms of pain, including pharmacological approaches (i.e., prescription or non-prescription drugs), physical therapy, exercise, surgery, psychological therapy, and complementary and alternative therapies.4 In order to decide what treatment is best for the patient, careful consideration should be given to the benefits and risks of the available treatment options.9 Medications, such as opioids, are commonly prescribed for pain, with approximately three to four percent of the adult population in the United States prescribed long-term opioid therapy.9,10 However, long-term opioid therapy presents some serious risks, including addiction, accidental overdose, hyperalgesia, and diversion for non-medical use.10

Mindfulness training is another potential treatment option for individuals who suffer from chronic pain.11 Mindfulness is defined as the intentional and non-judgmental conscious awareness of the present moment.12 A previous CADTH rapid response report that was published in 201211 examined the clinical effectiveness and evidence-based guidelines regarding the use of mindfulness training for chronic pain management in adults and found insufficient evidence to draw conclusions about its potential effectiveness. An update is needed to determine if the evidence surrounding mindfulness for chronic pain management is more conclusive to inform future policy decisions.

The aim of this report is to summarize the evidence regarding both the clinical and cost-effectiveness, as well as guidelines for the use of mindfulness training for chronic non-malignant pain management.

Research Questions

  1. What is the clinical effectiveness of mindfulness training for chronic non-malignant pain in adults?
  2. What is the cost-effectiveness of mindfulness training for chronic non-malignant pain in adults?
  3. What are the evidence-based guidelines regarding the use of mindfulness training for chronic non-malignant pain in adults?

Key Findings

Two systematic reviews and three randomized controlled trials (from four publications) were identified that addressed the clinical effectiveness of mindfulness training for chronic non-malignant pain in adults, and the results were inconclusive. One relevant systematic review did not identify any relevant studies. The results from the remaining clinical studies suggested that mindfulness training may be more clinically effective than pharmacotherapy or not significantly different from pharmacotherapy for chronic non-malignant pain, depending on the outcome or population examined. No studies found mindfulness training to be significantly less effective than pharmacotherapy. More research is warranted for definitive conclusions.

No evidence regarding the cost-effectiveness of mindfulness training for chronic non-malignant pain in adults were identified.

Three evidence-based guidelines, including one Canadian guideline, satisfied the inclusion criteria for this report. All guidelines recommend the use of mindfulness training for patients with chronic pain (e.g., chronic non-malignant pain, low back pain, and multi-symptom illness). Two of the included guidelines were informed from evidence of uncertain quality, suggesting caution should be exercised in their interpretation.

Methods

Literature Search Methods

A limited literature search was conducted by an information specialist on key resources including Medline, Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO, the Cochrane Library, the University of York Centre for Reviews and Dissemination (CRD) databases, the websites of Canadian and major international health technology agencies, as well as a focused Internet search. The search strategy was comprised of both controlled vocabulary, such as the National Library of Medicine’s MeSH (Medical Subject Headings), and keywords. The main search concepts were mindfulness and adults with chronic pain. No filters were applied to limit the retrieval by study type. The search was also limited to English language documents published between January 1, 2014 and May 28, 2019.

Selection Criteria and Methods

One reviewer screened citations and selected studies. In the first level of screening, titles and abstracts were reviewed and potentially relevant articles were retrieved and assessed for inclusion. The final selection of full-text articles was based on the inclusion criteria presented in Table 1.

Table 1. Selection Criteria.

Table 1

Selection Criteria.

Exclusion Criteria

Articles were excluded if they did not meet the selection criteria outlined in Table 1, they were duplicate publications, or were published prior to 2014. Systematic reviews and clinical studies were excluded if the comparator was described as usual care or similar (e.g., treatment as usual, standard of care, waitlist control) if no context was provided regarding what usual care involved (e.g., pharmacotherapy, physical therapy, cognitive behavioural therapy). Guidelines with unclear methodology were also excluded.

Critical Appraisal of Individual Studies

The included systematic reviews were critically appraised by one reviewer using A MeaSurement Tool to Assess systematic Reviews (AMSTAR) II,13 randomized controlled trials (RCTs) were critically appraised using Downs and Black checklist,14 and guidelines were assessed with the Appraisal of Guidelines, Research and Evaluation (AGREE) II15 instrument. Summary scores were not calculated for the included studies; rather, a review of the strengths and limitations of each included study were described narratively.

Summary of Evidence

Quantity of Research Available

A total of 666 citations were identified in the literature search. Following screening of titles and abstracts, 599 citations were excluded and 67 potentially relevant reports from the electronic search were retrieved for full-text review. Eight potentially relevant publications were retrieved from the grey literature search for full-text review. Of these 75 potentially relevant articles, 66 publications were excluded for various reasons, and nine publications met the inclusion criteria and were included in this report. These comprised two systematic reviews, three RCTs from four publications, and three evidence-based guidelines. Appendix 1 presents the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)16 flowchart of the study selection. Additional references of potential interest are provided in Appendix 5.

Summary of Study Characteristics

Study Design

Two systematic reviews,17,18 four publications describing three RCTs,1922 and three guidelines were identified.2325

One of the included systematic reviews,17 published in 2018, did not identify any relevant studies that considered the comparator of interest for this report (i.e., pharmacology). This review searched three academic databases, reference lists, and ClinicalTrials.gov for RCTs published through November 2017. The second of the included systematic reviews,18 published in 2017, identified one relevant study for this report. The review searched four academic databases for literature through June 2016 as well as reference lists of prior systematic reviews.18 Both reviews limited their eligibility criteria to RCTs.17,18

Results from three RCTs were reported in four included publications;1922 two of the included publications reported on the same RCT but examined different outcomes of interest.20,21

The three included guidelines were commissioned by two different organizations: The National Pain Center23 and the Department of Veterans Affairs/Department of Defense (VA/DoD).24,25 The 2017 Canadian Guideline for Opioids for Chronic Non-Cancer Pain conducted by the National Pain Center focused on providing guidance on the use of opioids, as well as other interventions (pharmacological and non-pharmacological), to manage chronic non-malignant pain for adults who are 18 years of age or older.23 This guideline was an update to the previous 2010 guideline and the updated guideline was externally peer-reviewed.23 The included recommendations relevant to this report were based on low to moderate quality evidence.23 The 2017 VA/DoD guideline focused on improving patients’ health and wellbeing by providing evidence-based guidance to providers who are diagnosing or treating adult patients with low back pain.25 This guideline was an update to a previous 2007 guideline and the updated guideline was externally peer-reviewed. Relevant to this report, the guidelines included weak recommendations derived from unclear quality of evidence (i.e., quality of evidence not reported) in favour of the recommendation, classified in the guideline as “new-replaced” (i.e., the recommendation from the previous guideline was carried over to the updated guideline and modified following review of the evidence).25 The 2014 VA/DoD guideline focused on providing guidance for primary care clinicians with a framework by which to evaluate the individual needs and preferences of patients who may be experiencing chronic multi-symptom illness or medically unexplained symptoms, leading to improved clinical outcomes.24 This guideline was an update to a previous 2001 guideline, but it was unclear whether the updated guideline was externally peer-reviewed. Relevant to this report, the guidelines included weak recommendations based on unclear quality of evidence (i.e., quality not reported) in favour of the recommendation, classified in the guideline as “new-replaced” (as defined above).24 All three included guidelines used the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach to assess the quality of the evidence.23,25

Country of Origin

The body of evidence originated from Canada (one guideline23), Iran (three publications describing two RCTs1921), and the United States (two systematic reviews,17,18 one RCT,22 two guidelines24,25).

Patient Population

The 2018 systematic review considered studies that included patients with chronic pain conditions (i.e., chronic low back pain; chronic neck pain; osteoarthritis of the knee, hip, or hand; fibromyalgia; and tension headache).17 This review, however, did not retrieve any relevant studies for the current report.17 The 2017 systematic review included RCTs with adult patients with chronic pain for a minimum of three months.18

All of the primary studies examined adult patients with migraine and/or chronic tension-type headaches,1922 with two publications reporting on the same RCT.20,21

The target population of the 2017 National Pain Center guideline is patients with chronic non-malignant pain.23 The intended users of the guideline are prescribers of opioids for the management of chronic non-malignant pain and those who create policy regarding this issue (e.g., primary care physicians, specialists who manage patients with chronic non-malignant pain, nurse practitioners, and regulatory agencies and other policy makers). The secondary audience of this guideline includes patients living with chronic non-malignant pain, pharmacists, and other health care professionals who manage patients with chronic non-malignant pain.23 For the 2017 VA/DoD guideline, the target population is patients with chronic low back pain.25 The intended users of the guideline are health care providers who manage patients with low back pain, including chronic low back pain conditions.25 The target population for the 2014 VA/DoD guideline is patients with multi-symptom illness (e.g., migraine and tension headaches, non-cardiac chest pain, irritable bowel syndrome, and a variety of chronic pain conditions), with a focus on patients who are eligible for care in the Veterans Health Administration or the Department of Defense health care delivery system.24 The intended users of this guideline are primary care providers who treat and manage adult patients with chronic multi-symptom illness.24

Interventions and Comparators

Pertinent to this report, the 2018 systematic review17 included mindfulness practices as the intervention and pharmacotherapy as the comparator. Relevant to this report, the 2017 systematic review18 included mindfulness-based stress reduction (MBSR) plus pharmacotherapy (i.e., over the counter and prescribed medications) as the intervention and pharmacotherapy alone as the comparator.

The three RCTs, reported in four included publications, comprised an eight-week MBSR intervention,1922 with two RCTs allowing for participants in the intervention group to receive usual pharmacotherapy (specific and non-specific drugs,19 prophylactic and abortive medications22) in addition to the MBSR. The comparator for all RCTs was usual pharmacotherapy.1922 Details on the specific type, duration, dose, and frequency of pharmacotherapy were not provided for any RCT.1922

Relevant to this report, all included guidelines2325 examined MBSR as a potential treatment for individuals who were living with chronic pain (i.e., chronic non-malignant pain, low back pain, multi-symptom illness).

Outcomes

For the systematic reviews, the outcomes of interest were function17 and pain.17,18 The RCTs investigated the following clinical outcomes: pain,19 pain severity,21 migraine/headache frequency,22 headache severity,22 headache duration,22 disability (e.g., Headache Impact Test-6 or HIT-6, Migraine Disability Assessment or MIDAS),22 quality of life (e.g., Migraine-Specific Quality of Life),19,22 perceived stress (e.g., Perceived Stress Scale),20,22 general mental health,20 anxiety/depression (e.g., Patient Health Questionnaire - depression module, State Trait Anxiety Inventory),22 mindful awareness (e.g., Five Factor Mindfulness Scale),21,22 and headache management self-efficacy.22 Relevant outcomes from the guidelines included pain,2325 function,23,25 symptom severity,24 and quality of life.24,25 The minimal clinically important difference was not defined for relevant outcomes of interest with the exception of one disability outcome, HIT-6, where the authors indicated “a change of 2.3 points on HIT-6 reflects the minimum important difference that reflects meaningful clinical change” (p. 1490).22 A detailed summary of the characteristics of included publications are provided in Appendix 2.

Summary of Critical Appraisal

Additional details regarding the strengths and limitations of included publications are provided in Appendix 3.

Systematic Reviews

Both systematic reviews used strong methodology and met the majority18 or all17 of the AMSTAR II checklist13 criteria. Common strengths of the reviews include a published predefined protocol, a clear description of research questions and eligibility criteria, and systematic searches to retrieve literature performed using multiple methods (e.g., academic databases, clinical trial registries).17,18 For transparency, the authors provided their full search strategies in the protocols and/or appendices.17,18 In both reviews, data selection and extraction were conducted independently and in duplicate, reasons for exclusion were provided, included studies were described in adequate detail, the strength of evidence was graded for each included study, and funding sources and any potential or actual conflicts of interest were disclosed.17,18 These strengths increase the reproducibility of the findings. The 2018 systematic review also provided a list of excluded studies in the appendix;17 however, the 2017 review did not.18 The 2017 review also did not justify why the review was limited to RCTs and no other study designs.18

Randomized Controlled Trials

The quality of evidence associated with the included RCTs was assessed using the Downs and Black Checklist.14 Overall, the quality of the included RCTs was variable.1922 For all RCTs, objectives and outcomes of interest were adequately described, group assignments were randomly allocated, the number of patients included and basic characteristics of study participants were described, results were adequately reported with actual probability values (P values), and funding sources were disclosed when applicable.1922 In addition, the authors of the included studies described sample size calculations2022 with the exception of one RCT.19 The investigators of one RCT prospectively registered the trial, attempted to blind patients, and also blinded the individuals who performed the data analyses;22 the investigators of the three other publications, reporting on two RCTs, did not mention registering their trial protocol nor did they mention using blinding strategies.1921 For all included RCTs, more detail about the medication type, dose, and frequency used by participants in the comparator group,1922 and in some cases the intervention group,19,22 was needed to aid in interpreting the findings. Finally, it was unclear whether included participants were representative of the source population or if the staff, places, and facilities where the patients were treated were representative of the treatment most patients receive.1922

Evidence-Based Guidelines

Strengths and weaknesses of the included evidence-based guidelines2325 were assessed using the AGREE II instrument.15 Overall, the included guidelines met most of the AGREE II criteria. Common strengths of the guidelines included: the overall objectives and populations to whom the guidelines apply were specifically described; guideline development groups included individuals from relevant professional groups; the target users of the guidelines were defined; systematic methods were used to search for evidence; the criteria for selecting the evidence, the strengths and limitations of the body of evidence, and the methods for formulating the recommendations were clearly described; there was an explicit link between the recommendations and the supporting evidence; a procedure for updating the guidelines was provided; the different options for management of the condition or health issue were clearly presented; key recommendations were easily identifiable; and the guideline described facilitators and barriers to its application.2325 These features may increase the reliability of the recommendations as they demonstrate sound methodology and make these guidelines less prone to biases. A common weakness of the three guidelines was the uncertainty and/or absence of presenting monitoring and/or auditing criteria.2325 These criteria are important after implementation of the guideline to determine, for example, if the guidelines resulted in improved patient health care outcomes. For the 2017 National Pain Center guideline,23 the recommendations regarding mindfulness were not specific or unambiguous; there were no explicit details on the MBSR interventions in the primary studies (e.g., no details on the duration of MBSR interventions). Also, it is uncertain whether two guidelines provided advice and/or tools on how the recommendations can be put into practice.23,24 Moreover, for the 2014 VA/DoD guideline,24 it was unclear if views and preferences of the target population had been sought, if the guideline was externally reviewed by experts prior to its publication or if competing interests of guideline development group members were recorded and addressed. Finally, for both VA/DoD guidelines,24,25 it is unclear if the funding bodies influenced the content of the guideline, an important piece for the overall interpretation of the recommendations suggested by the guidelines.

Summary of Findings

Appendix 4 presents a table of the main study findings and authors’ conclusions.

Clinical Effectiveness of Mindfulness Training

Two systematic reviews17,18 and four publications on three RCTs1922 examined the clinical effectiveness of mindfulness training for chronic non-malignant pain. Relevant to this report, these studies examined pain, function, and wellbeing outcomes. One of the included systematic reviews did not identify relevant studies; therefore, no summary of findings can be provided from this review.17

Pain

Pain outcomes were assessed and reported in one systematic review18 and three RCTs.19,21,22

In the systematic review,18 one included study met the eligibility criteria of the current report; therefore, the summary of findings is reflective of one study and no meta-analytic data are presented. The systematic review included a relevant RCT that compared a modified MBSR program plus pharmacotherapy (i.e., over-the-counter and prescribed medications; intervention) to pharmacotherapy (control) for patients with chronic low back pain and found no significant difference in total pain after eight-week and 24-week follow-up periods.18

One RCT examined the effect of MBSR plus usual pharmacotherapy (intervention) on pain in patients with migraines and chronic tension-type headaches compared to usual pharmacotherapy alone (control).19 Patients in the intervention group had a significant reduction in pain intensity scores compared to the control group.19 The second RCT of patients with migraines compared standardized MBSR plus usual pharmacotherapy (intervention) to pharmacotherapy alone (control).22 This RCT found significant reductions in headache duration in favour of the intervention immediately after the completion of the eight-week intervention, but not at one month post-intervention. The authors found no significant differences between groups for migraine frequency, headache frequency, and headache severity for both follow-up periods.22 In another RCT, the authors found MBSR was significantly more effective than usual pharmacotherapy as evidenced by significantly lower pain severity scores, and these improvements were more pronounced at immediately following the eight-week intervention versus three months follow-up.21

Disability

One RCT22 assessed disability at two different timepoints (immediately following the eight-week intervention and one month post-intervention) using two different outcomes: HIT-6 and MIDAS. This RCT compared standardized MBSR plus usual pharmacotherapy (intervention) to pharmacotherapy alone (control) and found a significant improvement in favour of the intervention for HIT-6 scores at both timepoints and MIDAS scores immediately after the eight-week intervention (no between-group differences at one month post-intervention). The study authors indicated that this magnitude of change in HIT-6 score was considered clinically meaningful.22

Wellbeing

Wellbeing outcomes were assessed in three RCTs (from four publications).1922

One RCT revealed MBSR plus usual pharmacology (intervention) was significantly more effective than usual pharmacotherapy alone (control) as evidenced by significantly higher quality of life scores for most categories from the 36-Item Short Form Survey (SF-36): role limitation due to physical health, bodily pain, general health, energy and vitality, affect health, sum of physical health dimensions, and sum of mental health.19 No significant differences were found for the physical functioning, role limitations due to emotional problems, and social functioning categories.19 In the RCT that compared MBSR (intervention) to usual pharmacotherapy (control), the authors found that mindfulness awareness scores improved significantly in favour of the intervention group, and these improvements were more pronounced at immediately following the eight-week intervention versus the three month follow-up period.21 The supporting publication of this RCT also examined perceived stress and general mental health.20 This publication found improvements in favour of the intervention for both perceived stress and general mental health, and these improvements were also more pronounced immediately following the eight-week intervention compared to the three month follow-up period.20 Finally, the RCT that compared standardized MBSR plus usual pharmacotherapy (intervention) to pharmacotherapy alone (control) also reported on wellbeing outcomes.22 This RCT found significant improvements in mindfulness awareness (both follow-up time points) and headache management self-efficacy (for eight-week follow-up) in favour of the intervention. No significant differences between groups were identified for Migraine-Specific Quality Of Life, Patient Health Questionnaire (Depression module), State Trait Anxiety Inventory or Perceived Stress Scale outcomes.22

Cost-Effectiveness of Mindfulness Training

No relevant evidence regarding the cost-effectiveness of mindfulness training for chronic non-malignant pain in adults was identified; therefore, no summary can be provided.

Guidelines

Three guidelines provide recommendations on the use of mindfulness training for chronic non-malignant pain in adults based on varying quality evidence.2325 The 2017 National Pain Center guideline provides recommendations for adults with chronic non-malignant pain.23 The guideline provides a strong recommendation, derived from low to moderate quality of evidence, for the optimization of non-opioid pharmacotherapy and non-pharmacotherapy versus opioid use. When focusing on non-pharmacotherapy interventions, the guideline provided evidence of small to moderate short-term benefit for MBSR.23 The 2017 VA/DoD guideline provides recommendations for adults for the management of (chronic) low back pain.25 The guideline provides weak recommendations, derived from unclear quality of evidence (i.e., quality not reported), in favour of offering MBSR for patients with chronic low back pain. The guideline also indicates that the overall benefits of MBSR outweigh any harms or burdens to the patient.25 The 2014 VA/DoD guideline provides recommendations for adults for the management of chronic multi-symptom illness.24 The guideline provides weak recommendations, derived from unclear quality of evidence (i.e., quality not reported), in favour of offering MBSR delivered by trained professionals for patients with chronic multi-symptom illness.24

Limitations

There are certain limitations to consider when reviewing the report. Several reports, often systematic reviews, were excluded at the screening stage due to the lack of details regarding the comparator. In numerous cases, the comparator was described as usual care, treatment as usual, standard care, or waitlist control with no details regarding what these comparators involved. Since it cannot be assumed that usual care always involves pharmacotherapy, these studies were excluded from the report. Investigators of future systematic reviews on this topic may consider providing more details about the comparators and contacting authors of the original studies to obtain this information, if not provided in the publications. In addition, one of the included systematic reviews examined the clinical effectiveness of mindfulness training for chronic non-malignant pain,17 however no relevant literature was identified, which may further highlight the lack of studies directly comparing MBSR to pharmacotherapy alone. Moreover, details on the specific type, duration, dose, and frequency of pharmacotherapy was not provided for any RCT,1922 which makes it difficult to precisely interpret the findings from these studies. The other systematic review that was included in this report only contained one relevant study that fulfilled the current eligibility criteria.18 Therefore, findings from the included study were described and no meta-analytic summary data from the systematic review could be reported. Most of the clinical evidence identified included patients with chronic headache pain;1922 therefore, it is unclear how effective mindfulness training may be for other types of chronic non-malignant pain (e.g., osteoarthritis, rheumatoid arthritis, neck pain, irritable bowel syndrome). For clinical studies that included MBSR plus usual pharmacotherapy as the intervention, it is not possible to discern the independent effect of mindfulness training.18,19,22 This report did not identify any cost-effectiveness studies for inclusion. Finally, only one report (i.e., guideline) was conducted in Canada;23 therefore, it is unclear how generalizable the results are to the Canadian context (e.g., available treatments, patient characteristics). This Canadian guideline disclosed that their recommendations were based on low- to moderate-quality evidence, but the quality of evidence that informed the other two guidelines was unclear.24,25 These limitations warrant the use of caution when interpreting the findings of this report.

Conclusions and Implications for Decision or Policy Making

This report identified evidence on the clinical effectiveness of mindfulness training for the management of chronic non-malignant pain in adults, and three evidence-based guidelines regarding the use of mindfulness training in this population. No evidence was identified for the cost-effectiveness of mindfulness training for the management of chronic non-malignant pain.

Regarding clinical effectiveness, two relevant systematic reviews17,18 and three RCTs from four publications1922 regarding mindfulness training for the management of chronic non-malignant pain were identified in the search. One of the systematic reviews did not identify any relevant studies and, therefore, no conclusions from this review can be provided. The remaining clinical studies explored pain, disability, and wellness outcomes and the clinical findings were mixed. Mindfulness training (with or without pharmacotherapy) either improved or did not significantly benefit patients with chronic pain in comparison to pharmacotherapy alone depending on the population of interest, health outcome or duration of follow-up. For example, MBSR (intervention) resulted in lower pain severity scores,21 lower perceived stress,20 increased mindfulness awareness,21 and ratings of general mental health20 compared to usual pharmacotherapy (control) for patients with chronic migraines immediately after the eight-week intervention. These findings were less apparent at three months after the intervention,20,21 suggesting the effects of the intervention may not be retained. When comparing MBSR plus usual pharmacotherapy (intervention) with usual pharmacotherapy (control) for patients with chronic headaches, there was a significant difference between groups in favour of the intervention for 10 clinical outcomes,19,22 a significant difference between groups in favour of the intervention immediately following the intervention but not 24 weeks post intervention for three outcomes,22 and no significant difference between groups for 10 outcomes.19,22 Moreover, modified MBSR plus usual pharmacotherapy did not improve total pain scores for patients with chronic low back pain immediately following an eight-week intervention nor at 24 weeks post-intervention.18 Importantly, patients in the mindfulness training groups did not perform significantly worse than pharmacotherapy alone.1822

Three evidence-based guidelines2325 were identified that provide recommendations regarding the use of mindfulness training for the management of chronic non-malignant pain in adults, including one Canadian guideline.23 Generally, the guidelines development groups recommend MBSR for patients with chronic pain (i.e., chronic non-malignant pain, low back pain, multi-symptom illness).

The previous 2012 CADTH rapid response report11 aimed to summarize clinical effectiveness and evidence-based guidelines regarding the use of mindfulness training for chronic pain management in adults. This report permitted mindfulness training to be compared to any other treatment. For this report, only comparisons with pharmacotherapy alone was allowed, and the search was expanded to also include cost-effectiveness literature on mindfulness training. By searching the literature from January 2014 through June 2019, nine relevant reports were identified. All these reports addressed clinical effectiveness or guideline recommendations; no relevant economic evaluations were identified. Overall, this report provided similar conclusions to the previous report in that some evidence about the potential effectiveness of mindfulness training for chronic non-malignant pain was identified, but the findings were insufficient draw definitive conclusions.

Further comparative studies evaluating the mindfulness training to pharmacotherapy alone (with details on type, dose, frequency) would enhance the utility of the evidence and better inform a determination concerning the effectiveness of mindfulness training in the care pathway for patients experiencing chronic non-malignant pain. Additional research is also required to discern the clinical effectiveness of mindfulness training alone (i.e., without a pharmacotherapy co-intervention), and the cost-effectiveness mindfulness training, for the management of chronic non-malignant pain in adults.

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Omidi A, Zargar F. Effects of mindfulness-based stress reduction on perceived stress and psychological health in patients with tension headache. J Res Med Sci. 2015;20(11):1058–1063. [PMC free article: PMC4755092] [PubMed: 26941809]
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Omidi A, Zargar F. Effect of mindfulness-based stress reduction on pain severity and mindful awareness in patients with tension headache: a randomized controlled clinical trial. Nurs. 2014;3(3):e21136. [PMC free article: PMC4332994] [PubMed: 25699282]
22.
Wells RE, Burch R, Paulsen RH, Wayne PM, Houle TT, Loder E. Meditation for migraines: a pilot randomized controlled trial. Headache. 2014;54(9):1484–1495. [PubMed: 25041058]
23.
Busse J, Guyatt G, Carrasco A. The 2017 Canadian guideline for opioids for chronic non-cancer pain. Hamilton (ON): Michael G. DeGroote National Pain Centre; 2017: http:​//nationalpaincentre​.mcmaster.ca/documents​/Opioid%20GL%20for​%20CMAJ_01may2017.pdf Accessed 2019 Jun 25.
24.
VA/DoD clinical practice guideline for the management of chronic multi-symptom illness Washington (DC): Department of Veteran Affairs; Department of Defense; 2014: https://www​.healthquality​.va.gov/guidelines​/MR/cmi/VADoDCMICPG2014.pdf Accessed 2019 Jun 14.
25.
VA/DoD clinical practice guideline for diagnosis and treatment of low back pain. Washington (DC): Department of Veterans Affairs; Department of Defense; 2017: https://www​.healthquality​.va.gov/guidelines​/Pain/lbp/VADoDLBPCPG092917.pdf. Accessed 2018 Jun 14.
26.
Systematic Review Update: Noninvasive Nonpharmacologic Treatments for Chronic Pain Research Protocol (Evidence-based Practice Center Systematic Review Protocol). Rockville (MD): Agency for Healthcare Research and Quality; 2019: https:​//effectivehealthcare​.ahrq.gov/topics​/noninvasive-nonpharm-pain-update​/protocol. Accessed 2019 Jun 17.
27.
Maglione M, Hempel S, Hilton L, et al. PROSPERO Mindfulness meditation for chronic pain (CRD42015025052). PROSPERO: International prospective register of systematic reviews. York (GB): University of York Centre for Reviews and Dissemination; 2015: https://www​.crd.york​.ac.uk/prospero/display_record​.php?RecordID=25052. Accessed 2016 Jun 25.

Appendix 1. Selection of Included Studies

Image app1f1

Appendix 2. Characteristics of Included Publications

Table 2Characteristics of Included Systematic Reviews and Meta-Analyses

First Author, Publication Year, CountryStudy Designs and Numbers of Primary Studies IncludedPopulation CharacteristicsIntervention and Comparator(s)Clinical Outcomes, Length of Follow-Up

Skelly, 201817

United States

0 relevant studies of the 202 included RCTsPatients with chronic pain conditions (chronic low back pain; chronic neck pain; osteoarthritis of the knee, hip, or hand; fibromyalgia; and tension headache)

Intervention: Mindfulness practices

Comparator: Pharmacotherapy

Function

Pain

Follow-up: not applicable

Hilton, 201718

United States

1 relevant study of the 38 included RCTsAdult patients with chronic pain for a minimum of 3 months (n = 40)

Intervention: Modified MBSR (body scan, sitting practice, walking meditation; 8 weeks) plus over the counter and prescribed medications

Comparator: over the counter and prescribed medications

Pain

Follow-up: unclear

MBSR = mindfulness-based stress reduction; RCT = randomized controlled trials.

Table 3Characteristics of Included Primary Clinical Studies

First Author, Publication Year, CountryStudy DesignPopulation CharacteristicsIntervention and Comparator(s)Clinical Outcomes, Length of Follow-Up

Bakhshani, 201619

Iran

RCT

Patients with migraine and chronic tension-type headache according to diagnostic criteria of the International Headache Classification Committee (n = 40)

Intervention: 20 participants; 70.0% female; mean age ± SD = 30.60 ± 9.08 years

Comparator: 20 participants; 65.0% female; mean age = 31.50 ± 9.57 years

Intervention: MBSR (8 weekly sessions) plus usual pharmacotherapy (including specific and non-specific drugs)

Comparator: usual pharmacotherapy (including specific and non-specific drugs)

Pain

Quality of life via SF-36 (sub-outcomes include role limitation due to physical health, bodily pain, general health, energy and vitality, affect health, sum of physical health dimensions, sum of mental health, physical functioning, role limitations due to emotional problems, social functioning)

Omidi 201520*

Iran

RCT

Adults with tension headache according to diagnostic criteria of the International Headache Classification Committee (n = 60)

Intervention: 30 participants; 76.7% female; mean age = 34.5 ± 2.41 years

Comparator: 30 participants; 83.3% female; mean age = 32.0 ± 3.20 years

Intervention: MBSR (8 weekly sessions)

Comparator: usual pharmacotherapy

Perceived stress

General mental health

Post-test: 8 weeks Follow-up: 3 months

Omidi, 201421*

Iran

RCT

Adults with tension headache according to diagnostic criteria of the International Headache Classification Committee (n = 60)

Intervention: 30 participants; mean age: 34.5 ± 2.41 years

Comparator: 30 participants; mean age = 32.0 ± 3.20 years

Intervention: MBSR (8 weekly sessions)

Comparator: usual pharmacotherapy

Pain severity

Mindful awareness

Post-test: 8 weeks Follow-up: 3 months

Wells, 201422

United States

RCT

Adults with migraines (n = 19)

Intervention: 10 participants; 90% female; mean age: 45.9 ± 17 years

Comparator: 9 participants; 89% female; mean age = 45.2 ± 12 years

Intervention: standardized MBSR course (8 weeks) plus usual prophylactic and abortive medications

Comparator: usual care, including prophylactic and abortive medications

Primary outcome: Migraine Frequency (number of migraines per month)

Secondary outcomes: Headache Frequency Per Month

Headache Severity

Headache Duration

Headache Impact Test-6 (HIT-6)

Migraine Disability Assessment (MIDAS)

Headache Management Self Efficacy

Five Factor Mindfulness

Migraine-Specific Quality of Life

Patient Health Questionnaire - depression module

State Trait Anxiety Inventory

Perceived Stress Scale

Initial follow-up: immediately after intervention ended (8 weeks)

Final follow-up: 1-month after intervention ended

MBSR = mindfulness-based stress reduction; RCT = randomized controlled trial; SD = standard deviation; SF-36 = 36-Item Short Form Survey.

*

Note. These two studies include the same patient population but explore different outcomes.

Table 4Characteristics of Included Guidelines

Intended Users, Target PopulationIntervention and Practice ConsideredMajor Outcomes ConsideredEvidence Collection, Selection, and SynthesisEvidence Quality AssessmentRecommendations Development and EvaluationGuideline Validation
National Pain Center (Canadian Guideline for Opioids for Chronic Non-Cancer Pain), 201723

Intended Users

Prescribers of opioids for the management of chronic non-malignant pain and those who create policy regarding this issue (e.g., primary care physicians, specialists who manage patients with chronic non-cancer pain, nurse practitioners, and regulatory agencies and other policy makers)

Secondary audiences:

  • Patients living with chronic non-cancer pain
  • Pharmacists
  • Other health care professionals who manage patients with chronic non-cancer pain

Target Population

Patients with chronic non-cancer pain

Interventions for the management of chronic non-cancer pain, including MBSR

Relevant to this report, function and pain

Selection and prioritization of questions and outcomes

Conduct systematic reviews

Develop a patient values and preferences statement to complement research findings and help guide Panel in making recommendations

GRADE

Guideline development process included 4 groups: 4-member steering committee, 15-member guideline panel, 13-member multidisciplinary clinical expert committee, and 16-member patient advisory committee

Conducted 2-day in-person meeting where the Guideline Panel voted anonymously after each evidence review (must be endorsed by at least 80% of panel members for acceptance of recommendation)

Recommendations shared with the Clinical Expert Committee for review and feedback and solicited feedback from patients, clinicians, and other stakeholders by posting on website and through press release, social media, and email

Externally peer-reviewed
VA/DoD, 201725

Intended Users

Health care providers who manage patients with low back pain, including chronic low back pain

Target Population

Patients with chronic low back pain

Interventions for the management of (chronic) low back pain, including MBSRRelevant to this report, function, pain and quality of life

Formulated and prioritized evidence questions

Conducted systematic review

Conducted focus groups with patients

GRADE (quality of evidence not reported for recommendation relevant to report)

Convened a face-to-face meeting with the CPG Champions and Work Group

CPG drafted by the Champions and Work Group sent out for internal and external peer review and comment.

All feedback reviewed, discussed, and considered by the Work Group

Modifications made throughout the CPG development process

Final CPG approved about the diagnosis and treatment of low back pain to the VA/DoD Evidence-Based Practice Working Group

Externally peer-reviewed
VA/DoD, 201424

Intended Users

Primary care providers who treat and manage adult patients with chronic multi-symptom illness (with focus on patients who are eligible for care in the Veterans Health Administration or the Department of Defense health care delivery system)

Target Population

Patients with multi-symptom illness (e.g., migraine and tension headaches, non-cardiac chest pain, irritable bowel syndrome, and a variety of chronic pain conditions)

Management approaches for multi-symptom illness, including non-pharmacologic therapies such as mindfulness-based therapy

Relevant to this report, pain reduction, symptom severity, and quality of life

Formulated and prioritized evidence questions

Conducted systematic review to update the 2001 CPG (search dates: January 2000 to October 2013)

GRADE (quality of evidence not reported for recommendation relevant to report)

Convened a face-to-face meeting with the CPG Champions and Work Group

Drafted and submitted final CPG on the management of chronic multi-symptom illness to the VA/DoD Evidence-Based Practice Working Group

Unclear

CPG = clinical practice guideline; DoD = Department of Defense; GRADE = Grading of Recommendations, Assessment, Development and Evaluations; MBSR = mindfulness-based stress reduction; VA = Department of Veterans Affairs.

Appendix 3. Critical Appraisal of Included Publications

Table 5Strengths and Limitations of Systematic Reviews and Meta-Analyses using AMSTAR II13

StrengthsLimitations
Skelly, 201817
  • Study authors published a systematic review protocol a priori26
  • Research questions clear and inclusion criteria for the review included the components of PICO
  • Multiple databases searched, ClinicalTrials​.gov searched for unpublished trials, reference lists of included studies reviewed for includable literature
  • Search strategy provided in protocol26 and appendix
  • Data selection and extraction conducted independently and in duplicate
  • Reasons for excluding studies provided in flow chart
  • List of excluded studies provided in appendix
  • Included studies described in adequate detail
  • Grading of the strength of evidence performed by at least two investigators independently based on Agency for Healthcare Research and Quality guidance
  • Methods used to combine study findings appropriate
  • Conflicts of interest discussed
  • Review authors acknowledged that this review is “based on research conducted by the Pacific Northwest Evidence-based Practice Center under contract to the Agency for Healthcare Research and Quality” (p. iii)
  • No major limitations identified
Hilton, 201718
  • Study authors published a systematic review protocol in PROSPERO27
  • Research questions clear and inclusion criteria for the review included the components of PICO
  • Full search strategy provided in protocol
  • Appropriate meta-analysis plan included a priori in protocol
  • Multiple databases and reference lists of systematic reviews searched
  • Keywords from search strategy provided
  • Data selection and extraction conducted independently and in duplicate
  • Risk of bias assessed using the Cochrane Risk of Bias tool
  • Other biases related to the US Preventive Services Task Force’s criteria for internal validity of included studies also assessed
  • Reasons for excluding studies provided in flow chart
  • Included studies described in adequate detail
  • Methods used to combine study findings appropriate
  • Study authors disclose funding, “The systematic review was sponsored by the Department of Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury (contract number 14-539.2).” (p.211)
  • Study authors report no conflicts of interest
  • Did not justify why study authors included RCTs and no other study designs
  • List of excluded studies not provided

AHRQ = Agency for Healthcare Research and Quality; PICO = Population Intervention, Comparator, Outcome.

Table 6Strengths and Limitations of Clinical Studies using Downs and Black14

StrengthsLimitations
Bakhshani, 201619
  • Objectives, intervention, and main outcomes of the study clearly described
  • Patients randomly allocated to group assignment
  • Actual probability values (P values) reported for significant outcomes
  • Estimates of the random variability provided as standard deviations for outcomes with significant findings
  • Number of patients included, and basic characteristics of the patients included in the study described
  • Authors reported that the study was supported by Zahedan University of Medical Sciences
  • More detail about the type and dose of medications used by participants in both groups was needed
  • Blinding not described (e.g., patients assigned to treatment allocations, evaluators who ascertained outcome data)
  • No sample size calculation for statistical power provided, and the authors acknowledged that the study includes a small sample
  • Actual probability values (P values) not reported for non-significant outcomes
  • It is unclear whether results were unbiased due to multiple testing (e.g., many subgroup analysis tests performed)
  • Estimates of the random variability not provided for outcomes with non-significant findings
  • It was unclear whether the participants were representative of the source population
  • It was unclear if the staff, places, and facilities where the patients were treated were representative of the treatment most of the patients receive
  • Any potential or actual conflicts of interest were not described
Omidi, 201520
  • Objectives and main outcomes of the study clearly described
  • Patients in both groups were from the same institution and recruited from the same period
  • Patients randomly allocated to group assignment
  • Appropriate statistical tests used to assess outcomes
  • Sample size for statistical power calculated
  • Actual probability values (P values) reported for outcome of interest
  • Estimates of the random variability provided as standard deviations
  • Number of patients included, and basic characteristics of the patients included in the study described
  • Main findings of the study described
  • Authors reported that they did no receive any funding to conduct the study and authors declared no conflicts of interest
  • More detail about the comparator was needed to better understand the type and dose of antidepressant medication used and what clinical management involved
  • Blinding not described (e.g., patients assigned to treatment allocations, evaluators who ascertained outcome data)
  • It was unclear whether the participants were representative of the source population
  • It was unclear if the staff, places, and facilities where the patients were treated were representative of the treatment most of the patients receive
Omidi, 201421
  • Objectives, intervention, and main outcomes of the study clearly described
  • Patients randomly allocated to group assignment
  • Patients in both groups were from the same institution and recruited from the same period
  • Appropriate statistical tests used to assess outcomes
  • Sample size for statistical power calculated
  • Actual probability values (P values) reported when values less than P = 0.001
  • Estimates of the random variability provided as standard deviations
  • Number of patients included, and basic characteristics of the patients included in the study described
  • Main findings of the study described
  • Authors reported that they received copies of MBSR guidelines by Jon Kabat-Zinn from the Center for Mindfulness at the University of Massachusetts
  • More detail about the comparator was needed to better understand the type and dose of antidepressant medication used and what clinical management involved
  • Blinding not described (e.g., patients assigned to treatment allocations, evaluators who ascertained outcome data)
  • It was unclear whether the participants were representative of the source population
  • It was unclear if the staff, places, and facilities where the patients were treated were representative of the treatment most of the patients receive
  • Any potential or actual conflicts of interest were not described
Wells, 201422
  • The study was prospectively registered
  • Objectives and main outcomes of the study clearly described
  • Patients randomly allocated to group assignment
  • Patients in both groups were from the same institution and recruited from the same period
  • Sample size for statistical power calculated
  • Attempts to blind patients performed
  • Appropriate statistical tests used to assess outcomes
  • Data analyses were performed blind (i.e., investigator)
  • Actual probability values (P values) reported when values less than P = 0.001
  • Estimates of the random variability provided as 95% confidence intervals
  • Number of patients included, and characteristics of the patients included in the study described
  • Main findings of the study adequately described
  • Authors reported that they were funded by the American Headache Society Fellowship and the Headache Research Fund of the John Graham Headache Center, Brigham and Women’s Faulkner Hospital.
  • Conflicts of interest disclosed
  • More detail about the type and dose of medications used by participants in both groups was needed (though the distinction between prophylactic and abortive medications was made)
  • It was unclear whether the participants were representative of the source population
  • It was unclear if the staff, places, and facilities where the patients were treated were representative of the treatment most of the patients receive

MBSR = mindfulness-based stress reduction.

Table 7Strengths and Limitations of Guidelines using AGREE II15

Guideline
ItemNational Pain Center, 201723VA/DoD, 201725VA/DoD, 201424
Domain 1: Scope and Purpose
1. The overall objective(s) of the guideline is (are) specifically described.
2. The health question(s) covered by the guideline is (are) specifically described.
3. The population (patients, public, etc.) to whom the guideline is meant to apply is specifically described.
Domain 2: Stakeholder Involvement
4. The guideline development group includes individuals from all relevant professional groups.
5. The views and preferences of the target population (patients, public, etc.) have been sought.unclear
6. The target users of the guideline are clearly defined.
Domain 3: Rigour of Development
7. Systematic methods were used to search for evidence.
8. The criteria for selecting the evidence are clearly described.
9. The strengths and limitations of the body of evidence are clearly described.
10. The methods for formulating the recommendations are clearly described.
11. The health benefits, side effects, and risks have been considered in formulating the recommendations.
12. There is an explicit link between the recommendations and the supporting evidence.
13. The guideline has been externally reviewed by experts prior to its publication.unclear
14. A procedure for updating the guideline is provided.
Domain 4: Clarity of Presentation
15. The recommendations are specific and unambiguous.
16. The different options for management of the condition or health issue are clearly presented.
17. Key recommendations are easily identifiable.
Domain 5: Applicability
18. The guideline describes facilitators and barriers to its application.
19. The guideline provides advice and/or tools on how the recommendations can be put into practice.unclearunclear
20. The potential resource implications of applying the recommendations have been considered.
21. The guideline presents monitoring and/or auditing criteria.unclearunclearunclear
Domain 6: Editorial Independence
22. The views of the funding body have not influenced the content of the guideline.unclearunclear
23. Competing interests of guideline development group members have been recorded and addressed.unclear

CAD = Canadian Guideline for Opioids for Chronic Non-Cancer Pain; DoD = Department of Defense; VA = Department of Veterans Affairs.

Appendix 4. Main Study Findings and Authors’ Conclusions

Table 8Summary of Findings Included Systematic Reviews and Meta-Analyses

Main Study FindingsAuthors’ Conclusion
Skelly, 201817

MBSR versus Pharmacotherapy for Chronic Low Back Pain

No studies of MBSR versus pharmacotherapy met inclusion criteria.

MBSR versus Pharmacotherapy for Fibromyalgia

No studies of MBSR versus pharmacotherapy met inclusion criteria.

Not applicable
Hilton, 201718

SF MPQ—total pain (24-week follow-up)

Standard mean difference (95% CI) = −0.04 (−0.7 to 0.63), representing a no significant differences between groups

SF MPQ—total pain (8-week follow-up)

Standard mean difference (95% CI) = −0.01 (−0.68 to 0.65), representing no significant difference between groups

Not applicable

MBSR = mindfulness-based stress reduction; SF MPQ = Short-Form McGill Pain Questionnaire.

Table 9Summary of Findings of Included Primary Clinical Studies

Main Study FindingsAuthors’ Conclusion
Bakhshani, 201619

Pain results derived from analysis of covariance (ANCOVA); results presented as mean ± SD

  • Significantly lower pain intensity scores in favour of intervention (53.89 ± 2.40) versus control (71.94 ± 2.20), P = 0.001
    • Covariate “pre-test of pain” was significant P = 0.001, indicating that level of pain intensity before MBSR intervention had a significant effect on level of pain intensity

Quality of Life results derived from covariance analysis (MANCOVA); results presented as mean ± SD

  • Role limitation due to physical health (RP)
    • Significant difference in favour of intervention group (61.62 ± 6.18) when compared to control group (40.24 ± 5.62), P = 0.025
  • Bodily pain
    • Significant difference in favour of intervention group (48.97 ± 2.98) when compared to control group (33.58 ± 2.71), P = 0.002
  • General health
    • Significant difference in favour of intervention group (48.77 ± 2.85) when compared to control group (36.05 ± 2.59), P = 0.005
  • Energy and vitality
    • Significant difference in favour of intervention group (44.99 ± 2.81) when compared to control group (30.50 ± 2.56), P = 0.002
  • Affect health
    • Significant difference in favour of intervention group (52.60 ± 1.97) when compared to control group (34.49 ± 1.80), P = 0001
  • Sum of physical health dimensions
    • Significant difference in favour of intervention group (58.52 ± 2.72) when compared to control group (46.13 ± 2.48), P = 0.004
  • Sum of mental health
    • Significant difference in favour of intervention group (44.82 ± 2.43) when compared to control group (33.32 ± 2.21), P = 0.002
  • Physical functioning
    • No significant difference in scores between intervention and control, P > 0.05
  • Role limitations due to emotional problems
    • No significant difference in scores between intervention and control, P > 0.05
  • Social functioning
    • No significant difference in scores between intervention and control, P > 0.05

The findings from this study revealed that MBSR can be used non-pharmacological intervention for improvement the quality of life and development of strategies to cope with pain in patients with chronic headache. And can be used in combination with other therapies such as pharmacotherapy.” (p. 142)

According to the findings of this study it can be concluded that MBSR methods generally are effective on perceived pain intensity and quality of life of patients with chronic headache. Although there was no statistically significant difference in some aspects of quality of life, such as physical functioning, role limitations due to emotional problems and social functioning, but overall changes in mean were desired to the study. Thus, the integrating of MBSR treatment with conventional medical therapy in the treatment protocol for patients with chronic headache can be advised. The researcher also believes that despite the shortcomings and deficiencies of current research, this study could be a new approach to the treatment of chronic headache and could provide a new horizon in this field of treatment.” (p. 149)

Omidi, 201520

Table 3. Means, SDs, and comparison of outcome measures at pre-treatment, post-treatment, and follow-up stages in the MBSR and TAU groups*

MBSR could reduce stress and improve general mental health in patients with tension headache.” (p. 2)

Our study supports the hypothesis that patients suffering from tension headache can enhance their general mental health by participating in the MBSR program. In summary, the results of the present study suggest that MBSR can reduce pain-related anxiety and interference in daily activities in the short term. The unique features of mindfulness exercises are easy training and no need to complex cognitive abilities.” (p. 6)

Outcome measureGroupPre-testaPost-testaFollow-upaTime × Group (P value)Time (P valueGroup (P value
Perceived stress scaleMBSR TAU

16.96 (2.53)

15.9 (2.86)

12.7 (2.69)

16.13 (2.44)

13.5 (2.33)

15.76 (2.22)

0.0010.0010.001
Total score of BSI (GSI)

MBSR

TAU

1.63 (0.56)

1.77 (0.50)

0.73 (0.46)

1.59 (0.52)

0.93 (0.34)

1.78 (0.47)

0.0010.0010.001
a Data presented as mean (SD). P value less than 0.05 defined as significant.
Omidi, 201421

Pain Severity (via International Headache Classification Subcommittee Diary Scale for Headache; presented as mean ± SD)

  • MBSR: baseline = 7.36 ± 1.25; post-test = 5.62 ± 1.74; follow-up = 6.07 ± 1.08
  • TAU: baseline = 7.5 ± 1.35; post-test = 7.48 ± 1.27; follow-up = 7.48 ± 1.18
  • Repeated measures ANOVA revealed an interaction between time and group: P < 0.001

Mindfulness Awareness (via Mindful Attention Awareness Scale; presented as mean ± SD)

  • MBSR: baseline = 34.9 ± 10.5; post-test = 53.8 ± 15.5; follow-up = 40.7 ± 10.9
  • TAU: baseline= 53.8 ± 18.1; post-test = 49.8 ± 13.4; follow-up = 50.36 ± 14.1
  • Repeated measures ANOVA revealed an interaction between time and group: P < 0.001

MBSR could reduce pain and improve mindfulness skills in patients with tension headache. It appears that MBSR is an effective psychotherapy for treatment of patients with tension headache.” (p. 1)

In summary, the results of the present study suggest that MBSR can reduce pain-related anxiety and interference in daily activities in the short term. It is suggested to perform future studies to compare efficacy of MBSR with other traditional and newer cognitive behavioral therapies in patients with tension headache. Based on this study, MBSR is recommended as an effective psychotherapy for reducing the pain in patients with tension headache and other illness with pain.” (p. 4)

Wells, 201422

Note. Main results derived from independent t-tests; results presented as differential change (95% CI)

Migraine Frequency Per Month (primary outcome)

  • No significant difference between groups for both initial and final follow-up

Headache Frequency Per Month

  • No significant difference between groups for both initial and final follow-up

Headache Severity (0–10 scale)

  • No significant difference between groups for both initial and final follow-up

Headache Duration (hours)

  • Initial follow-up: 2.9 fewer hours per headache (95% CI, −4.6 to −0.02) in favour of intervention (5.1 to 2.9) versus control (6.4 to 6.1), P = 0.043
  • Final follow-up: non-significant

Headache Impact Test-6 (HIT-6, a disability outcome)

  • Initial follow-up: 4.8 fewer points (95% CI, −11.0 to −1.0) in favour of intervention (62.5 to 57.5) versus control (63.0 to 64.0), P = 0.043
  • Final follow-up: 4.1 fewer points (95% CI, −9.0 to −1.0) in favour of intervention (62.5 to 60.0) versus control (63.0 to 63.0), P = 0.022

Migraine Disability Assessment (MIDAS, a disability outcome)

  • Initial follow-up: 12.6 points fewer (95% CI, −22.0 to −1.0) in favour of intervention (17.0 to 4.5) versus control (11.0 to 14.0), P = 0.017
  • Final follow-up: non-significant

Headache Management Self Efficacy

  • Initial follow-up: 13.2 points increase (95% CI, 1.0 to 30.0) in favour of intervention (111.5 to 124.0) versus control (128.0 to 117.0), P = 0.035
  • Final follow-up: non-significant

Five Factor Mindfulness

  • Initial follow-up: 13.1-point increase (95% CI, 3.0 to 26.0) in favour of intervention (142.0 to 150.0) versus control (150.0 to 141.0), P = 0.035
  • Final follow-up: 17.3-point increase (95% CI, 1.3 to 33.2) in favour of intervention (142.0 to 157.5) versus control (150.0 to 138.0), P = 0.045

Migraine-Specific Quality of Life

  • No significant difference between groups for both initial and final follow-up

Patient Health Questionnaire - depression module

  • No significant difference between groups for both initial and final follow-up

State Trait Anxiety Inventory

  • No significant difference between groups for both initial and final follow-up

Perceived Stress Scale

  • No significant difference between groups for both initial and final follow-up

MBSR is safe and feasible for adults with migraines. Although the small sample size of this pilot trial did not provide power to detect statistically significant changes in migraine frequency or severity, secondary outcomes demonstrated this intervention had a beneficial effect on headache duration, disability, self-efficacy, and mindfulness. Future studies with larger sample sizes are warranted to further evaluate this intervention for adults with migraines.” (p. 1484)

Nonetheless, our findings in this pilot trial support the potential safety, feasibility, and efficacy of a standardized mind/body intervention for migraineurs.” (p. 1492)

ANOVA = analysis of variance; BSI = Brief Symptom Inventory; GSI = Global Severity Index; MBSR: mindfulness-based stress reduction; SD = standard deviation; TAU = treatment as usual.

*

Modified from Omidi A, Zargar F. Effects of mindfulness-based stress reduction on perceived stress and psychological health in patients with tension headache. J Res Med Sci. 2015;20(11):1058–1063. Licensed under https:​//creativecommons​.org/licenses/by/3.0/

Table 10. Summary of Recommendations in Included Guidelines (PDF, 251K)

Appendix 5. Additional References of Potential Interest

Authors’ response to a letter to the editor regarding guideline included in this report

  • Busse JW, Juurlink DN, Buckley DN, Guyatt GH. The authors respond to “Inconsistencies in the 2017 Canadian Guideline for Opioids for Chronic Non-cancer Pain”. CMAJ: Canadian Medical Association Journal. 2017 Oct 2;189(39):E1234. [PMC free article: PMC5628038] [PubMed: 28970263]

Reviews with “treatment as usual/waitlist control” comparator

  • Jackson W, Zale EL, Berman SJ, Malacarne A, Lapidow A, Schatman ME, Kulich R, Vranceanu AM. Physical functioning and mindfulness skills training in chronic pain: a systematic review. J Pain Res. 2019;12:179. [PMC free article: PMC6322706] [PubMed: 30655687]
  • Khoo EL, Small R, Cheng W, Hatchard T, Glynn B, Rice DB, Skidmore B, Kenny S, Hutton B, Poulin PA. Comparative evaluation of group-based mindfulness-based stress reduction and cognitive behavioural therapy for the treatment and management of chronic pain: A systematic review and network meta-analysis. Evid Based Ment Health. 2019 Feb 1;22(1):26–35. [PubMed: 30705039]
  • Mikolasek M, Berg J, Witt CM, Barth J. Effectiveness of mindfulness-and relaxation-based eHealth interventions for patients with medical conditions: a systematic review and synthesis. Int J Behav Med. 2018 Feb 1;25(1):1–6. [PubMed: 28752414]
  • Ball EF, Nur Shafina Muhammad Sharizan E, Franklin G, Rogozińska E. Does mindfulness meditation improve chronic pain? A systematic review. Curr Opin Obstet Gynecol. 2017 Dec 1;29(6):359–66. [PubMed: 28961631]
  • Chou R, Deyo R, Friedly J, Skelly A, Hashimoto R, Weimer M, Fu R, Dana T, Kraegel P, Griffin J, Grusing S. Nonpharmacologic therapies for low back pain: a systematic review for an American College of Physicians Clinical Practice Guideline. Ann Intern Med. 2017 Apr 4;166(7):493–505. [PubMed: 28192793]
  • Toivonen KI, Zernicke K, Carlson LE. Web-based mindfulness interventions for people with physical health conditions: systematic review. J Med Internet Res. 2017;19(8):e303. [PMC free article: PMC5599726] [PubMed: 28860106]
  • Veehof MM, Trompetter HR, Bohlmeijer ET, Schreurs KM. Acceptance-and mindfulness-based interventions for the treatment of chronic pain: a meta-analytic review. Cogn Behav Ther. 2016 Jan 2;45(1):5–31. [PubMed: 26818413]
  • Crowe M, Jordan J, Burrell B, Jones V, Gillon D, Harris S. Mindfulness-based stress reduction for long-term physical conditions: A systematic review. Aust N Z J Psychiatry. 2016 Jan;50(1):21–32. [PubMed: 26419491]
  • Bawa FL, Mercer SW, Atherton RJ, Clague F, Keen A, Scott NW, Bond CM. Does mindfulness improve outcomes in patients with chronic pain? Systematic review and meta-analysis. Br J Gen Pract. 2015 Jun 1;65(635):e387–400. [PMC free article: PMC4439829] [PubMed: 26009534]
  • Theadom A, Cropley M, Smith HE, Feigin VL, McPherson K. Mind and body therapy for fibromyalgia. Cochrane Database Syst Rev. 2015 Apr 9;(4):CD001980. [PubMed: 25856658]
  • Song Y, Lu H, Chen H, Geng G, Wang J. Mindfulness intervention in the management of chronic pain and psychological comorbidity: A meta-analysis. Int J Nurs Sci. 2014 Jun 1;1(2):215–23.
  • Garmon B, Philbrick J, Padrick M, Goodman M. Mindfulness-based stress reduction for chronic pain: A systematic review. J Pain Manag. 2014;7(1):23.

Primary studies with unclear comparator (i.e., may include medications but description is unclear)

  • Simmons LA, Williams H, Silva S, Keefe F, Tanabe P. Acceptability and Feasibility of a Mindfulness-Based Intervention for Pain Catastrophizing among Persons with Sickle Cell Disease. Pain Manag Nurs. 2019 May 10. [PubMed: 31085097]
  • Turner JA, Anderson ML, Balderson BH, Cook AJ, Sherman KJ, Cherkin DC. Mindfulness-based stress reduction and cognitive-behavioral therapy for chronic low back pain: similar effects on mindfulness, catastrophizing, self-efficacy, and acceptance in a randomized controlled trial. Pain. 2016 Nov;157(11):2434. [PMC free article: PMC5069124] [PubMed: 27257859]
  • Cherkin DC, Sherman KJ, Balderson BH, Cook AJ, Anderson ML, Hawkes RJ, Hansen KE, Turner JA. Effect of mindfulness-based stress reduction vs cognitive behavioral therapy or usual care on back pain and functional limitations in adults with chronic low back pain: a randomized clinical trial. JAMA. 2016 Mar 22;315(12):1240–9. [PMC free article: PMC4914381] [PubMed: 27002445]

Related CADTH reports

About the Series

CADTH Rapid Response Report: Summary with Critical Appraisal
ISSN: 1922-8147

Version: 1.0

Funding: CADTH receives funding from Canada’s federal, provincial, and territorial governments, with the exception of Quebec.

Suggested citation:

Mindfulness Training for Chronic Non-malignant Pain Management: A Review of the Clinical Effectiveness, Cost-effectiveness and Guidelines. Ottawa: CADTH; 2019 Jun. (CADTH rapid response report: summary with critical appraisal).

Disclaimer: The information in this document is intended to help Canadian health care decision-makers, health care professionals, health systems leaders, and policy-makers make well-informed decisions and thereby improve the quality of health care services. While patients and others may access this document, the document is made available for informational purposes only and no representations or warranties are made with respect to its fitness for any particular purpose. The information in this document should not be used as a substitute for professional medical advice or as a substitute for the application of clinical judgment in respect of the care of a particular patient or other professional judgment in any decision-making process. The Canadian Agency for Drugs and Technologies in Health (CADTH) does not endorse any information, drugs, therapies, treatments, products, processes, or services.

While care has been taken to ensure that the information prepared by CADTH in this document is accurate, complete, and up-to-date as at the applicable date the material was first published by CADTH, CADTH does not make any guarantees to that effect. CADTH does not guarantee and is not responsible for the quality, currency, propriety, accuracy, or reasonableness of any statements, information, or conclusions contained in any third-party materials used in preparing this document. The views and opinions of third parties published in this document do not necessarily state or reflect those of CADTH.

CADTH is not responsible for any errors, omissions, injury, loss, or damage arising from or relating to the use (or misuse) of any information, statements, or conclusions contained in or implied by the contents of this document or any of the source materials.

This document may contain links to third-party websites. CADTH does not have control over the content of such sites. Use of third-party sites is governed by the third-party website owners’ own terms and conditions set out for such sites. CADTH does not make any guarantee with respect to any information contained on such third-party sites and CADTH is not responsible for any injury, loss, or damage suffered as a result of using such third-party sites. CADTH has no responsibility for the collection, use, and disclosure of personal information by third-party sites.

Subject to the aforementioned limitations, the views expressed herein are those of CADTH and do not necessarily represent the views of Canada’s federal, provincial, or territorial governments or any third party supplier of information.

This document is prepared and intended for use in the context of the Canadian health care system. The use of this document outside of Canada is done so at the user’s own risk.

This disclaimer and any questions or matters of any nature arising from or relating to the content or use (or misuse) of this document will be governed by and interpreted in accordance with the laws of the Province of Ontario and the laws of Canada applicable therein, and all proceedings shall be subject to the exclusive jurisdiction of the courts of the Province of Ontario, Canada.

Copyright © 2019 Canadian Agency for Drugs and Technologies in Health.

The copyright and other intellectual property rights in this document are owned by CADTH and its licensors. These rights are protected by the Canadian Copyright Act and other national and international laws and agreements. Users are permitted to make copies of this document for non-commercial purposes only, provided it is not modified when reproduced and appropriate credit is given to CADTH and its licensors.

Except where otherwise noted, this work is distributed under the terms of a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International licence (CC BY-NC-ND), a copy of which is available at http://creativecommons.org/licenses/by-nc-nd/4.0/

Bookshelf ID: NBK546001PMID: 31498576

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