- Email: [email protected]
Yoga Treatment for Chronic Non-Specific Low Back Pain (2017)
Author’s Accepted Manuscript Acupuncture for the prevention of tension-type headache (2016) Alison Whitehead, L. Susan Wieland
www.elsevier.com/locate/jsch
PII: DOI: Reference:
S1550-8307(17)30123-4 http://dx.doi.org/10.1016/j.explore.2017.04.018 JSCH2209
To appear in: Explore: The Journal of Science and Healing Cite this article as: Alison Whitehead and L. Susan Wieland, Acupuncture for the prevention of tension-type headache (2016), Explore: The Journal of Science and Healing, http://dx.doi.org/10.1016/j.explore.2017.04.018 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting galley proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
Acupuncture for the prevention of tension-type headache (2016). SECTION HEAD: COCHRANE REVIEWS
This article is one of a series of commentaries published periodically in EXPLORE on recent Cochrane reviews. The commentaries are coordinated by Cochrane Complementary Medicine, which is a member group of Cochrane, an international non-profit organization that prepares systematic reviews of health interventions and publishes these reviews in the Cochrane Library (cochranelibrary.com). Cochrane Complementary Medicine is dedicated to facilitating the production and dissemination of Cochrane reviews of complementary, alternative and integrative therapies. The Group is based at the University of Maryland Center for Integrative Medicine, and funded by the NIH National Center for Complementary and Integrative Health (R24 AT001293). For additional information on Cochrane Complementary Medicine please contact Lisa Susan Wieland, PhD at [email protected].
Yoga for Chronic Non-Specific Low Back Pain
Alison Whitehead MPH RYT L. Susan Wieland PhD Citation: Wieland LS, Skoetz N, Pilkington K, Vempati R, D’Adamo CR, Berman BM. Yoga treatment for chronic non-specific low back pain. Cochrane Database of Systematic Reviews 2017, Issue 1. Art. No.: CD010671. DOI: 10.1002/14651858.CD010671.pub2.
Abstract Background Non-specific low back pain is a common, potentially disabling condition usually treated with self-care and non-prescription medication. For chronic low back pain, current guidelines state that exercise therapy may be beneficial. Yoga is a mind-body exercise sometimes used for non-specific low back pain. Objectives To assess the effects of yoga for treating chronic non-specific low back pain, compared to no specific treatment, a minimal intervention (e.g. education), or another active treatment, with a focus on pain, function, and adverse events. Search methods We searched CENTRAL, MEDLINE, Embase, five other databases and four trials registers to 11 March 2016 without restriction of language or publication status. We screened reference lists and contacted experts in the field to identify additional studies.
1
Selection criteria We included randomized controlled trials of yoga treatment in people with chronic non-specific low back pain. We included studies comparing yoga to any other intervention or to no intervention. We also included studies comparing yoga as an adjunct to other therapies, versus those other therapies alone. Data collection and analysis Two authors independently screened and selected studies, extracted outcome data, and assessed risk of bias. We contacted study authors to obtain missing or unclear information. We evaluated the overall certainty of evidence using the GRADE approach. Main results We included 12 trials (1080 participants) carried out in the USA (seven trials), India (three trials), and the UK (two trials). Studies were unfunded (one trial), funded by a yoga institution (one trial), funded by nonprofit or government sources (seven trials), or did not report on funding (three trials). Most trials used Iyengar, Hatha, or Viniyoga forms of yoga. The trials compared yoga to no intervention or a non-exercise intervention such as education (seven trials), an exercise intervention (three trials), or both exercise and non-exercise interventions (two trials). All trials were at high risk of performance and detection bias because participants and providers were not blinded to treatment assignment, and outcomes were selfassessed. Therefore, we downgraded all outcomes to 'moderate' certainty evidence because of risk of bias, and when there was additional serious risk of bias, unexplained heterogeneity between studies, or the analyses were imprecise, we downgraded the certainty of the evidence further. For yoga compared to non-exercise controls (9 trials; 810 participants), there was low-certainty evidence that yoga produced small to moderate improvements in back-related function at three to four months (standardized mean difference (SMD) -0.40, 95% confidence interval (CI) -0.66 to -0.14; corresponding to a change in the Roland-Morris Disability Questionnaire of mean difference (MD) -2.18, 95% -3.60 to 0.76), moderate-certainty evidence for small to moderate improvements at six months (SMD -0.44, 95% CI -0.66 to -0.22; corresponding to a change in the Roland-Morris Disability Questionnaire of MD -2.15, 95% -3.23 to -1.08), and low-certainty evidence for small improvements at 12 months (SMD -0.26, 95% CI -0.46 to -0.05; corresponding to a change in the Roland-Morris Disability Questionnaire of MD -1.36, 95% -2.41 to -0.26). On a 0-100 scale there was very low- to moderate-certainty evidence that yoga was slightly better for pain at three to four months (MD -4.55, 95% CI -7.04 to -2.06), six months (MD -7.81, 95% CI -13.37 to -2.25), and 12 months (MD -5.40, 95% CI -14.50 to -3.70), however we pre-defined clinically significant changes in pain as 15 points or greater and this threshold was not met. Based on information from six trials, there was moderate-certainty evidence that the risk of adverse events, primarily increased back pain, was higher in yoga than in non-exercise controls (risk difference (RD) 5%, 95% CI 2% to 8%). For yoga compared to non-yoga exercise controls (4 trials; 394 participants), there was very-low-certainty evidence for little or no difference in back-related function at three months (SMD -0.22, 95% CI -0.65 to 0.20; corresponding to a change in the Roland-Morris Disability Questionnaire of MD -0.99, 95% -2.87 to 0.90) and six months (SMD -0.20, 95% CI -0.59 to 0.19; corresponding to a change in the Roland-Morris Disability Questionnaire of MD -0.90, 95% -2.61 to 0.81), and no information on back-related function after six months. There was very low-certainty evidence for lower pain on a 0-100 scale at seven months (MD -20.40, 95% CI -25.48 to -15.32), and no information on pain at three months or after seven months. Based on information from three trials, there was low-certainty evidence for no difference in the risk of adverse events between yoga and non-yoga exercise controls (RD 1%, 95% CI -4% to 6%). For yoga added to exercise compared to exercise alone (1 trial; 24 participants), there was very-lowcertainty evidence for little or no difference at 10 weeks in back-related function (SMD -0.60, 95% CI 1.42 to 0.22; corresponding to a change in the Oswestry Disability Index of MD -17.05, 95% -22.96 to 2
11.14) or pain on a 0-100 scale (MD -3.20, 95% CI -13.76 to 7.36). There was no information on outcomes at other time points. There was no information on adverse events. Studies provided limited evidence on risk of clinical improvement, measures of quality of life, and depression. There was no evidence on work-related disability. Authors' conclusions There is low- to moderate-certainty evidence that yoga compared to non-exercise controls results in small to moderate improvements in back-related function at three and six months. Yoga may also be slightly more effective for pain at three and six months, however the effect size did not meet predefined levels of minimum clinical importance. It is uncertain whether there is any difference between yoga and other exercise for back-related function or pain, or whether yoga added to exercise is more effective than exercise alone. Yoga is associated with more adverse events than non-exercise controls, but may have the same risk of adverse events as other back-focused exercise. Yoga is not associated with serious adverse events. There is a need for additional high-quality research to improve confidence in estimates of effect, to evaluate long-term outcomes, and to provide additional information on comparisons between yoga and other exercise for chronic non-specific low back pain. Commentary Close to 50 million adults in the US are burdened with chronic or severe pain, (1), with a direct cost estimated at 100 billion dollars per year (2). Opioids, often used as treatment for pain, are involved in the majority of drug overdoses in the U.S. with approximately 91 Americans dying from opioid overdose each day according to the Centers for Disease Control (3). With the high prevalence of pain and the opioid epidemic in the U.S., there is an increased interest in and need for non-pharmacological approaches to pain care, and Federal Agencies have been taking measures to address the opioid epidemic and promote the use of complementary and integrative health (CIH) approaches (4,5). Low back pain (LBP), which is often of unknown etiology, is among top reasons for doctor visits (6,7), frequently leads to missed work days and job-related disability, and is experienced by approximately 80% of U.S. adults at some point in their lifetime (8). LBP, as defined in this Review, is chronic if it persists for more than 3 months (9). Current standards of care for treating chronic LBP (CLBP) include pain medications (over the counter and prescription), self-management, patient education, exercise, and other non-pharmacological therapies. However, a large percentage of individuals with CLBP continue to experience substantial pain and disability, despite the array of pharmacologic and surgical options available (10). Recently, yoga was added as an evidence-based treatment for CLBP in the American College of Physicians, American Pain Society joint clinical practice guidelines (11). This Cochrane Review examines the randomized clinical trial (RCT) evidence for yoga as an intervention for non-specific CLBP, with an emphasis on the outcomes of pain, function, and adverse events. While there have been a number of RCTs investigating yoga for LBP, and a few smaller reviews published (9), this Review, which includes 12 RCTs with a total of 1080 participants, provides the most recent, comprehensive, and rigorous approach to assessing the current research on this question (9). Yoga is a philosophy and practical science which originated in ancient India (12,13,14). Yoga, also described as a Discipline or Tradition, includes a variety of mind-body-affecting practices, such as study and application of philosophy, breathing, physical postures, cleansings, use of sound, visualization, meditation, and relaxation practices (14,15). Yoga has gained in popularity in the U.S. in recent years, and was practiced by approximately 21 million (9.5%) of U.S. adults in 2012 (up from 5.1% in 2002), according to a report from the National Center for Health Statistics based on the National Health Interview Survey (16). In a 2016 survey conducted by Yoga Journal and Yoga Alliance, it was estimated that over 36 million Americans have participated in a yoga class over their lifetime (17). While many people practice yoga as a means of personal evolution, many others practice primarily as a form of exercise or for the health benefits. 3
The Review found yoga to be better than non-exercise controls (e.g., education) for improving backrelated function, and slightly better for treating pain. No difference was observed between yoga and nonyoga exercise interventions for back related function, although there was limited information for this comparison. An important finding was that yoga appeared to be safe for individuals with CLBP, as it was not associated with serious adverse events. There was a 5% greater risk of non-serious adverse events, primarily increased back pain, with yoga compared to not doing exercise, and no difference in adverse events between yoga and non-yoga exercise interventions. Cochrane reviews use the GRADE system to assess the certainty of the evidence for each outcome (18, 19). Although evidence based on RCTs is initially assessed as high certainty, this may be downgraded to moderate, low, or very low certainty, based on presence of risk of bias, inconsistency between trials, indirectness of the evidence, imprecision of the results, or a strong suspicion of publication bias (18,19). The participants in the yoga trials included in this review knew whether they were practicing yoga or not, and their outcomes were self-reported or assessed by other unblinded assessors, therefore, all of the outcomes in this review were affected by risk of bias from lack of blinding, and were downgraded to moderate certainty. Due to the nature of yoga and many complementary health interventions, blinding of participants and providers as to treatment group, and assessors (if self-reported outcomes), is not practical or possible. Additionally, when a field of research is fairly young, studies are likely to be few in number and small, leading to further downgrading of the evidence due to imprecision (e.g., fewer than 400 participants in a comparison). Another factor to consider with yoga is the variability of the interventions, potentially leading to heterogeneity between studies and thus further downgrading of the certainty of the evidence. When evidence is rated as low certainty, it implies that further research is likely to change the estimate of effect. These are important considerations to keep in mind when judging the impact of the results on clinical recommendations. Yoga is a mind-body science incorporating more than just physical postures and breath awareness. Yoga interventions that did not include physical postures were not included in this review. Additionally, some of the trials did not include a meditation component, and specific yogic breathing practices were either not included or were variable among trials. Future research should address the potential effects of breathing, relaxation, meditation, and lifestyle components of yoga on CLBP. Although many studies included the specific postures they used, studies focusing on the comparison of the particular style of yoga and specific postures would be helpful for understanding what is the most effective yoga style for treating CLBP. The yoga instructors participating in the trials were listed as all having experience working with people with LBP, but had a range of experience and training levels. While yoga can be helpful for CLBP, there may be contraindicated poses. Adequate training and experience of teachers is important, especially when yoga is being used as part of a treatment plan. Clinicians and patients should ask about the yoga instructor’s level and type of training. As more specific training of teachers for particular health indications becomes available and yoga therapy a more recognized, certified, and perhaps licensed practice, the application of yoga to health challenges will likely become more accepted and supported (20). Yoga, like most other interventions for back pain, is not a one-time cure. Continued and consistent practice is probably necessary for optimal effectiveness. Classes in the interventions lasted for a limited number of weeks and outcomes were measured out to a year in some cases. The studies in the review included little information on long term outcomes, and the ideal dose and intensity of yoga for CLBP is still unknown. It wasn’t clear in all cases what was included in the non-yoga exercise (e.g. stretching may be very similar to some components of yoga). The populations in the studies were mostly higher socioeconomic status (SES) (only one trial included lower SES). These are additional limitations of the evidence base for yoga treatment.
4
Even though the evidence was of moderate to very low certainty, given its relative safety, the trends toward positive results, and the high rates of chronic pain and opioid use, yoga should be considered as a potential approach to include as part of a patient’s care plan for non-specific CLBP. Similar to non-yoga exercise, yoga helps bring movement into the body. However, yoga also supports the development of body-awareness and focus on posture and alignment, as well as assists with physical and mental stress, which may be particularly important in the management of CLBP. The VA, which oversees the largest integrated health care system in the U.S., has been implementing yoga and other CIH approaches as part of their whole health model of care, and there are studies looking specifically at the use of yoga for conditions including CLBP in Veterans (21,22). Similarly, yoga and other CIH approaches are being offered to active duty military on various military bases and hospitals (24). Additional RCTs and comparative effectiveness trials are warranted to provide more guidance on specific poses, different styles of yoga, frequency and duration of sessions, and other components of yoga, such as meditation, breathing, sound, visualization, and philosophy. There are additional completed yoga for CLBP trials which are awaiting publication, as well as some ongoing trials (9), and the authors are planning to update the review within the next couple of years. As the volume of the scientific evidence grows it will be interesting to see if the strength of the evidence for efficacy and effectiveness does too. If so, perhaps increased public use and health care provider referrals, as well as insurance coverage of yoga, will be a part of the solution for CLBP.
References 1. NCCIH Journal of Pain 2015 - http://americanpainsociety.org/about-us/press-room/nih-studyshows-prevalence-of-chronic-or-severe-pain-in-u-s-adults 2. Institute of Medicine. Relieving pain in America: a blueprint for transforming prevention, care, education, and research. Washington DC: National Academies Press; 2011. 3. Centers for Disease Control Injury Prevention & Control: Opioid Overdose. https://www.cdc.gov/drugoverdose/epidemic/index.html Accessed March 26, 2017 4. VA Health Research & Development website. NIH-DoD-VA Pain Management Collaboratory https://www.hsrd.research.va.gov/funding/pain-mgmt-collab-2017.cfm Accessed March 24, 2017 5. Health and Human Services. Surgeon General Priorities – Opioids. https://www.surgeongeneral.gov/priorities/opioids/ Accessed March 24, 2017 6. US Burden of Disease Collaborators. The state of US health, 1990-2010: burden of diseases, injuries, and risk factors. JAMA. 2013;310:591-608. 7. Qaseem A, Wilt TJ, McLean RM, Forciea MA, for the Clinical Guidelines Committee of the American College of Physicians. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. [Epub ahead of print 14 February 2017]:. doi: 10.7326/M16-2367 8. https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Low-Back-PainFact-Sheet Accessed March 24 2017 9. Wieland LS, Skoetz N, Pilkington K, Vempati R, D’Adamo CR, Berman BM. Yoga treatment for chronic non-specific low back pain. Cochrane Database of Systematic Reviews 2017, Issue 1. Art. No.: CD010671. DOI: 10.1002/14651858.CD010671.pub2. 10. Balague F, Mannion AF, Fellise F, Cedraschi C. Non-specific low back pain. Lancet 2012;379:482-91. 11. Chou R, Huffman LH. Nonpharmacologic therapies for acute and chronic low back pain: a review of the evidence for an American Pain Society/American College of Physicians clinical practice guideline. Ann Intern Med. 2007;147:492–504. 5
12. Arya U. Yoga-Sutras of Patajali with the Exposition of Vyasa, A Translation and Commentary. Vol One, Samadhi-pada. Honesdale, PA: The Himalayan Institute of Yoga Science and Philosophy of the USA; 1986. 13. Frawley D. Yoga and Ayerveda: Self-Healing and Self-Realization. Twin Lakes, WI: Lotus Press; 1999. 14. Gould Fogerite S, Goldberg, G. Overview of Mind Body Therapies in Complementary Therapies for Physical Therapy: A clinical decision making approach. Deutsch, J. and Anderson, E, Ed. Saunders, Elsevier, Inc. St. Louis, MO, pp 84-120, 2008. 15. Rama S. Path of Fire and Light. Vol 1. Honesdale: The Himalayan Institute Press; 1996. 16. Cramer H, Ward L, Steel A, Lauche R, Dobos G, Zhang Y. Prevalence, patterns, and predictors of yoga use: results of a U.S. nationally representative survey. American Journal of Preventive Medicine 2016;50(2):230–5. [PUBMED: 26497261] 17. Yoga in America Study. Yoga Journal. http://www.yogajournal.com/yogainamericastudy/ Accessed March 24, 2017 18. Cochrane handbook or website? 19. http://www.gradeworkinggroup.org/ 20. http://www.iayt.org/ 21. Saper RB, Lemaster CM, Elwy AR, Paris R, Herman PM, Plumb DN, Sherman KJ, Groessl EJ, Lynch S, Wang S, Weinberg J. Yoga versus education for Veterans with chronic low back pain: study protocol for a randomized controlled trial. Trials. 2016 Apr 29;17(1):224. doi: 10.1186/s13063-016-1321-5. PubMed PMID: 27129472; PubMed Central PMCID: PMC4850721. 22. Groessl EJ, Weingart KR, Johnson N, Baxi S. The benefits of yoga for women veterans with chronic low back pain. Journal of Alternative and Complementary Medicine (New York, N.Y.) 2012;18(9):832–8. 23. Jonas WB, Welton RC, Delgado RE, et al. CAM in the United States Military: too little of a good thing? Med Care. 2014;52(suppl 5):S9–S12.
6
www.elsevier.com/locate/jsch
PII: DOI: Reference:
S1550-8307(17)30123-4 http://dx.doi.org/10.1016/j.explore.2017.04.018 JSCH2209
To appear in: Explore: The Journal of Science and Healing Cite this article as: Alison Whitehead and L. Susan Wieland, Acupuncture for the prevention of tension-type headache (2016), Explore: The Journal of Science and Healing, http://dx.doi.org/10.1016/j.explore.2017.04.018 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting galley proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
Acupuncture for the prevention of tension-type headache (2016). SECTION HEAD: COCHRANE REVIEWS
This article is one of a series of commentaries published periodically in EXPLORE on recent Cochrane reviews. The commentaries are coordinated by Cochrane Complementary Medicine, which is a member group of Cochrane, an international non-profit organization that prepares systematic reviews of health interventions and publishes these reviews in the Cochrane Library (cochranelibrary.com). Cochrane Complementary Medicine is dedicated to facilitating the production and dissemination of Cochrane reviews of complementary, alternative and integrative therapies. The Group is based at the University of Maryland Center for Integrative Medicine, and funded by the NIH National Center for Complementary and Integrative Health (R24 AT001293). For additional information on Cochrane Complementary Medicine please contact Lisa Susan Wieland, PhD at [email protected].
Yoga for Chronic Non-Specific Low Back Pain
Alison Whitehead MPH RYT L. Susan Wieland PhD Citation: Wieland LS, Skoetz N, Pilkington K, Vempati R, D’Adamo CR, Berman BM. Yoga treatment for chronic non-specific low back pain. Cochrane Database of Systematic Reviews 2017, Issue 1. Art. No.: CD010671. DOI: 10.1002/14651858.CD010671.pub2.
Abstract Background Non-specific low back pain is a common, potentially disabling condition usually treated with self-care and non-prescription medication. For chronic low back pain, current guidelines state that exercise therapy may be beneficial. Yoga is a mind-body exercise sometimes used for non-specific low back pain. Objectives To assess the effects of yoga for treating chronic non-specific low back pain, compared to no specific treatment, a minimal intervention (e.g. education), or another active treatment, with a focus on pain, function, and adverse events. Search methods We searched CENTRAL, MEDLINE, Embase, five other databases and four trials registers to 11 March 2016 without restriction of language or publication status. We screened reference lists and contacted experts in the field to identify additional studies.
1
Selection criteria We included randomized controlled trials of yoga treatment in people with chronic non-specific low back pain. We included studies comparing yoga to any other intervention or to no intervention. We also included studies comparing yoga as an adjunct to other therapies, versus those other therapies alone. Data collection and analysis Two authors independently screened and selected studies, extracted outcome data, and assessed risk of bias. We contacted study authors to obtain missing or unclear information. We evaluated the overall certainty of evidence using the GRADE approach. Main results We included 12 trials (1080 participants) carried out in the USA (seven trials), India (three trials), and the UK (two trials). Studies were unfunded (one trial), funded by a yoga institution (one trial), funded by nonprofit or government sources (seven trials), or did not report on funding (three trials). Most trials used Iyengar, Hatha, or Viniyoga forms of yoga. The trials compared yoga to no intervention or a non-exercise intervention such as education (seven trials), an exercise intervention (three trials), or both exercise and non-exercise interventions (two trials). All trials were at high risk of performance and detection bias because participants and providers were not blinded to treatment assignment, and outcomes were selfassessed. Therefore, we downgraded all outcomes to 'moderate' certainty evidence because of risk of bias, and when there was additional serious risk of bias, unexplained heterogeneity between studies, or the analyses were imprecise, we downgraded the certainty of the evidence further. For yoga compared to non-exercise controls (9 trials; 810 participants), there was low-certainty evidence that yoga produced small to moderate improvements in back-related function at three to four months (standardized mean difference (SMD) -0.40, 95% confidence interval (CI) -0.66 to -0.14; corresponding to a change in the Roland-Morris Disability Questionnaire of mean difference (MD) -2.18, 95% -3.60 to 0.76), moderate-certainty evidence for small to moderate improvements at six months (SMD -0.44, 95% CI -0.66 to -0.22; corresponding to a change in the Roland-Morris Disability Questionnaire of MD -2.15, 95% -3.23 to -1.08), and low-certainty evidence for small improvements at 12 months (SMD -0.26, 95% CI -0.46 to -0.05; corresponding to a change in the Roland-Morris Disability Questionnaire of MD -1.36, 95% -2.41 to -0.26). On a 0-100 scale there was very low- to moderate-certainty evidence that yoga was slightly better for pain at three to four months (MD -4.55, 95% CI -7.04 to -2.06), six months (MD -7.81, 95% CI -13.37 to -2.25), and 12 months (MD -5.40, 95% CI -14.50 to -3.70), however we pre-defined clinically significant changes in pain as 15 points or greater and this threshold was not met. Based on information from six trials, there was moderate-certainty evidence that the risk of adverse events, primarily increased back pain, was higher in yoga than in non-exercise controls (risk difference (RD) 5%, 95% CI 2% to 8%). For yoga compared to non-yoga exercise controls (4 trials; 394 participants), there was very-low-certainty evidence for little or no difference in back-related function at three months (SMD -0.22, 95% CI -0.65 to 0.20; corresponding to a change in the Roland-Morris Disability Questionnaire of MD -0.99, 95% -2.87 to 0.90) and six months (SMD -0.20, 95% CI -0.59 to 0.19; corresponding to a change in the Roland-Morris Disability Questionnaire of MD -0.90, 95% -2.61 to 0.81), and no information on back-related function after six months. There was very low-certainty evidence for lower pain on a 0-100 scale at seven months (MD -20.40, 95% CI -25.48 to -15.32), and no information on pain at three months or after seven months. Based on information from three trials, there was low-certainty evidence for no difference in the risk of adverse events between yoga and non-yoga exercise controls (RD 1%, 95% CI -4% to 6%). For yoga added to exercise compared to exercise alone (1 trial; 24 participants), there was very-lowcertainty evidence for little or no difference at 10 weeks in back-related function (SMD -0.60, 95% CI 1.42 to 0.22; corresponding to a change in the Oswestry Disability Index of MD -17.05, 95% -22.96 to 2
11.14) or pain on a 0-100 scale (MD -3.20, 95% CI -13.76 to 7.36). There was no information on outcomes at other time points. There was no information on adverse events. Studies provided limited evidence on risk of clinical improvement, measures of quality of life, and depression. There was no evidence on work-related disability. Authors' conclusions There is low- to moderate-certainty evidence that yoga compared to non-exercise controls results in small to moderate improvements in back-related function at three and six months. Yoga may also be slightly more effective for pain at three and six months, however the effect size did not meet predefined levels of minimum clinical importance. It is uncertain whether there is any difference between yoga and other exercise for back-related function or pain, or whether yoga added to exercise is more effective than exercise alone. Yoga is associated with more adverse events than non-exercise controls, but may have the same risk of adverse events as other back-focused exercise. Yoga is not associated with serious adverse events. There is a need for additional high-quality research to improve confidence in estimates of effect, to evaluate long-term outcomes, and to provide additional information on comparisons between yoga and other exercise for chronic non-specific low back pain. Commentary Close to 50 million adults in the US are burdened with chronic or severe pain, (1), with a direct cost estimated at 100 billion dollars per year (2). Opioids, often used as treatment for pain, are involved in the majority of drug overdoses in the U.S. with approximately 91 Americans dying from opioid overdose each day according to the Centers for Disease Control (3). With the high prevalence of pain and the opioid epidemic in the U.S., there is an increased interest in and need for non-pharmacological approaches to pain care, and Federal Agencies have been taking measures to address the opioid epidemic and promote the use of complementary and integrative health (CIH) approaches (4,5). Low back pain (LBP), which is often of unknown etiology, is among top reasons for doctor visits (6,7), frequently leads to missed work days and job-related disability, and is experienced by approximately 80% of U.S. adults at some point in their lifetime (8). LBP, as defined in this Review, is chronic if it persists for more than 3 months (9). Current standards of care for treating chronic LBP (CLBP) include pain medications (over the counter and prescription), self-management, patient education, exercise, and other non-pharmacological therapies. However, a large percentage of individuals with CLBP continue to experience substantial pain and disability, despite the array of pharmacologic and surgical options available (10). Recently, yoga was added as an evidence-based treatment for CLBP in the American College of Physicians, American Pain Society joint clinical practice guidelines (11). This Cochrane Review examines the randomized clinical trial (RCT) evidence for yoga as an intervention for non-specific CLBP, with an emphasis on the outcomes of pain, function, and adverse events. While there have been a number of RCTs investigating yoga for LBP, and a few smaller reviews published (9), this Review, which includes 12 RCTs with a total of 1080 participants, provides the most recent, comprehensive, and rigorous approach to assessing the current research on this question (9). Yoga is a philosophy and practical science which originated in ancient India (12,13,14). Yoga, also described as a Discipline or Tradition, includes a variety of mind-body-affecting practices, such as study and application of philosophy, breathing, physical postures, cleansings, use of sound, visualization, meditation, and relaxation practices (14,15). Yoga has gained in popularity in the U.S. in recent years, and was practiced by approximately 21 million (9.5%) of U.S. adults in 2012 (up from 5.1% in 2002), according to a report from the National Center for Health Statistics based on the National Health Interview Survey (16). In a 2016 survey conducted by Yoga Journal and Yoga Alliance, it was estimated that over 36 million Americans have participated in a yoga class over their lifetime (17). While many people practice yoga as a means of personal evolution, many others practice primarily as a form of exercise or for the health benefits. 3
The Review found yoga to be better than non-exercise controls (e.g., education) for improving backrelated function, and slightly better for treating pain. No difference was observed between yoga and nonyoga exercise interventions for back related function, although there was limited information for this comparison. An important finding was that yoga appeared to be safe for individuals with CLBP, as it was not associated with serious adverse events. There was a 5% greater risk of non-serious adverse events, primarily increased back pain, with yoga compared to not doing exercise, and no difference in adverse events between yoga and non-yoga exercise interventions. Cochrane reviews use the GRADE system to assess the certainty of the evidence for each outcome (18, 19). Although evidence based on RCTs is initially assessed as high certainty, this may be downgraded to moderate, low, or very low certainty, based on presence of risk of bias, inconsistency between trials, indirectness of the evidence, imprecision of the results, or a strong suspicion of publication bias (18,19). The participants in the yoga trials included in this review knew whether they were practicing yoga or not, and their outcomes were self-reported or assessed by other unblinded assessors, therefore, all of the outcomes in this review were affected by risk of bias from lack of blinding, and were downgraded to moderate certainty. Due to the nature of yoga and many complementary health interventions, blinding of participants and providers as to treatment group, and assessors (if self-reported outcomes), is not practical or possible. Additionally, when a field of research is fairly young, studies are likely to be few in number and small, leading to further downgrading of the evidence due to imprecision (e.g., fewer than 400 participants in a comparison). Another factor to consider with yoga is the variability of the interventions, potentially leading to heterogeneity between studies and thus further downgrading of the certainty of the evidence. When evidence is rated as low certainty, it implies that further research is likely to change the estimate of effect. These are important considerations to keep in mind when judging the impact of the results on clinical recommendations. Yoga is a mind-body science incorporating more than just physical postures and breath awareness. Yoga interventions that did not include physical postures were not included in this review. Additionally, some of the trials did not include a meditation component, and specific yogic breathing practices were either not included or were variable among trials. Future research should address the potential effects of breathing, relaxation, meditation, and lifestyle components of yoga on CLBP. Although many studies included the specific postures they used, studies focusing on the comparison of the particular style of yoga and specific postures would be helpful for understanding what is the most effective yoga style for treating CLBP. The yoga instructors participating in the trials were listed as all having experience working with people with LBP, but had a range of experience and training levels. While yoga can be helpful for CLBP, there may be contraindicated poses. Adequate training and experience of teachers is important, especially when yoga is being used as part of a treatment plan. Clinicians and patients should ask about the yoga instructor’s level and type of training. As more specific training of teachers for particular health indications becomes available and yoga therapy a more recognized, certified, and perhaps licensed practice, the application of yoga to health challenges will likely become more accepted and supported (20). Yoga, like most other interventions for back pain, is not a one-time cure. Continued and consistent practice is probably necessary for optimal effectiveness. Classes in the interventions lasted for a limited number of weeks and outcomes were measured out to a year in some cases. The studies in the review included little information on long term outcomes, and the ideal dose and intensity of yoga for CLBP is still unknown. It wasn’t clear in all cases what was included in the non-yoga exercise (e.g. stretching may be very similar to some components of yoga). The populations in the studies were mostly higher socioeconomic status (SES) (only one trial included lower SES). These are additional limitations of the evidence base for yoga treatment.
4
Even though the evidence was of moderate to very low certainty, given its relative safety, the trends toward positive results, and the high rates of chronic pain and opioid use, yoga should be considered as a potential approach to include as part of a patient’s care plan for non-specific CLBP. Similar to non-yoga exercise, yoga helps bring movement into the body. However, yoga also supports the development of body-awareness and focus on posture and alignment, as well as assists with physical and mental stress, which may be particularly important in the management of CLBP. The VA, which oversees the largest integrated health care system in the U.S., has been implementing yoga and other CIH approaches as part of their whole health model of care, and there are studies looking specifically at the use of yoga for conditions including CLBP in Veterans (21,22). Similarly, yoga and other CIH approaches are being offered to active duty military on various military bases and hospitals (24). Additional RCTs and comparative effectiveness trials are warranted to provide more guidance on specific poses, different styles of yoga, frequency and duration of sessions, and other components of yoga, such as meditation, breathing, sound, visualization, and philosophy. There are additional completed yoga for CLBP trials which are awaiting publication, as well as some ongoing trials (9), and the authors are planning to update the review within the next couple of years. As the volume of the scientific evidence grows it will be interesting to see if the strength of the evidence for efficacy and effectiveness does too. If so, perhaps increased public use and health care provider referrals, as well as insurance coverage of yoga, will be a part of the solution for CLBP.
References 1. NCCIH Journal of Pain 2015 - http://americanpainsociety.org/about-us/press-room/nih-studyshows-prevalence-of-chronic-or-severe-pain-in-u-s-adults 2. Institute of Medicine. Relieving pain in America: a blueprint for transforming prevention, care, education, and research. Washington DC: National Academies Press; 2011. 3. Centers for Disease Control Injury Prevention & Control: Opioid Overdose. https://www.cdc.gov/drugoverdose/epidemic/index.html Accessed March 26, 2017 4. VA Health Research & Development website. NIH-DoD-VA Pain Management Collaboratory https://www.hsrd.research.va.gov/funding/pain-mgmt-collab-2017.cfm Accessed March 24, 2017 5. Health and Human Services. Surgeon General Priorities – Opioids. https://www.surgeongeneral.gov/priorities/opioids/ Accessed March 24, 2017 6. US Burden of Disease Collaborators. The state of US health, 1990-2010: burden of diseases, injuries, and risk factors. JAMA. 2013;310:591-608. 7. Qaseem A, Wilt TJ, McLean RM, Forciea MA, for the Clinical Guidelines Committee of the American College of Physicians. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. [Epub ahead of print 14 February 2017]:. doi: 10.7326/M16-2367 8. https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Low-Back-PainFact-Sheet Accessed March 24 2017 9. Wieland LS, Skoetz N, Pilkington K, Vempati R, D’Adamo CR, Berman BM. Yoga treatment for chronic non-specific low back pain. Cochrane Database of Systematic Reviews 2017, Issue 1. Art. No.: CD010671. DOI: 10.1002/14651858.CD010671.pub2. 10. Balague F, Mannion AF, Fellise F, Cedraschi C. Non-specific low back pain. Lancet 2012;379:482-91. 11. Chou R, Huffman LH. Nonpharmacologic therapies for acute and chronic low back pain: a review of the evidence for an American Pain Society/American College of Physicians clinical practice guideline. Ann Intern Med. 2007;147:492–504. 5
12. Arya U. Yoga-Sutras of Patajali with the Exposition of Vyasa, A Translation and Commentary. Vol One, Samadhi-pada. Honesdale, PA: The Himalayan Institute of Yoga Science and Philosophy of the USA; 1986. 13. Frawley D. Yoga and Ayerveda: Self-Healing and Self-Realization. Twin Lakes, WI: Lotus Press; 1999. 14. Gould Fogerite S, Goldberg, G. Overview of Mind Body Therapies in Complementary Therapies for Physical Therapy: A clinical decision making approach. Deutsch, J. and Anderson, E, Ed. Saunders, Elsevier, Inc. St. Louis, MO, pp 84-120, 2008. 15. Rama S. Path of Fire and Light. Vol 1. Honesdale: The Himalayan Institute Press; 1996. 16. Cramer H, Ward L, Steel A, Lauche R, Dobos G, Zhang Y. Prevalence, patterns, and predictors of yoga use: results of a U.S. nationally representative survey. American Journal of Preventive Medicine 2016;50(2):230–5. [PUBMED: 26497261] 17. Yoga in America Study. Yoga Journal. http://www.yogajournal.com/yogainamericastudy/ Accessed March 24, 2017 18. Cochrane handbook or website? 19. http://www.gradeworkinggroup.org/ 20. http://www.iayt.org/ 21. Saper RB, Lemaster CM, Elwy AR, Paris R, Herman PM, Plumb DN, Sherman KJ, Groessl EJ, Lynch S, Wang S, Weinberg J. Yoga versus education for Veterans with chronic low back pain: study protocol for a randomized controlled trial. Trials. 2016 Apr 29;17(1):224. doi: 10.1186/s13063-016-1321-5. PubMed PMID: 27129472; PubMed Central PMCID: PMC4850721. 22. Groessl EJ, Weingart KR, Johnson N, Baxi S. The benefits of yoga for women veterans with chronic low back pain. Journal of Alternative and Complementary Medicine (New York, N.Y.) 2012;18(9):832–8. 23. Jonas WB, Welton RC, Delgado RE, et al. CAM in the United States Military: too little of a good thing? Med Care. 2014;52(suppl 5):S9–S12.
6