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1.  Impact of Iyengar yoga on quality of life in young women with rheumatoid arthritis 
The Clinical journal of pain  2013;29(11):988-997.
Objective
Rheumatoid arthritis (RA) is a chronic, disabling disease that can greatly compromise health related quality of life (HRQOL). The aim of this study was to assess the impact of a 6-week twice/week Iyengar yoga (IY) program on HRQOL of young adults with RA compared to a usual-care waitlist control group.
Method
The program was designed to improve the primary outcome of HRQOL including pain, as well as disability and psychological functioning in patients. Assessments were collected pre, post, and at 2-months following treatment. Weekly ratings of anxiety, depression, pain and sleep were also recorded. A total of 26 participants completed the intervention (yoga = 11; usual care waitlist = 15). All participants were female (mean age =28 years).
Results
Overall attrition was low at 15%. On average, women in the yoga group attended 96% of the yoga classes. No adverse events were reported. Relative to the usual-care waitlist, women assigned to the yoga program showed significantly greater improvement on standardized measures of HRQOL, pain disability, general health, mood, fatigue, acceptance of chronic pain and self-efficacy regarding pain at post treatment. Almost half of the yoga group reported clinically meaningful symptom improvement. Analysis of the uncontrolled effects and maintenance of treatment effects showed improvements in HRQOL general health, pain disability and weekly ratings of pain, anxiety and depression that maintained at follow-up.
Conclusion
The findings suggest a brief IY intervention is a feasible and safe adjunctive treatment for young people with RA, leading to health related quality of life (HRQOL), pain disability, fatigue, and mood benefits. Moreover, improvements in quality of life, pain disability and mood persisted at the 2-month follow-up.
doi:10.1097/AJP.0b013e31827da381
PMCID: PMC3644391  PMID: 23370082
Yoga; arthritis; young adults
2.  Effectiveness of Iyengar yoga in treating spinal (back and neck) pain: A systematic review 
Considerable amount of money spent in health care is used for treatments of lifestyle related, chronic health conditions, which come from behaviors that contribute to morbidity and mortality of the population. Back and neck pain are two of the most common musculoskeletal problems in modern society that have significant cost in health care. Yoga, as a branch of complementary alternative medicine, has emerged and is showing to be an effective treatment against nonspecific spinal pain. Recent studies have shown positive outcome of yoga in general on reducing pain and functional disability of the spine. The objective of this study is to conduct a systematic review of the existing research within Iyengar yoga method and its effectiveness on relieving back and neck pain (defined as spinal pain). Database research form the following sources (Cochrane library, NCBI PubMed, the Clinical Trial Registry of the Indian Council of Medical Research, Google Scholar, EMBASE, CINAHL, and PsychINFO) demonstrated inclusion and exclusion criteria that selected only Iyengar yoga interventions, which in turn, identified six randomized control trials dedicated to compare the effectiveness of yoga for back and neck pain versus other care. The difference between the groups on the postintervention pain or functional disability intensity assessment was, in all six studies, favoring the yoga group, which projected a decrease in back and neck pain. Overall six studies with 570 patients showed, that Iyengar yoga is an effective means for both back and neck pain in comparison to control groups. This systematic review found strong evidence for short-term effectiveness, but little evidence for long-term effectiveness of yoga for chronic spine pain in the patient-centered outcomes.
doi:10.4103/0973-6131.146046
PMCID: PMC4278133  PMID: 25558128
Back pain; complementary alternative medicine; effectiveness; Iyengar yoga; neck pain; randomized control trials; spine pain
3.  Protocol for a randomized controlled study of Iyengar yoga for youth with irritable bowel syndrome 
Trials  2011;12:15.
Introduction
Irritable bowel syndrome affects as many as 14% of high school-aged students. Symptoms include discomfort in the abdomen, along with diarrhea and/or constipation and other gastroenterological symptoms that can significantly impact quality of life and daily functioning. Emotional stress appears to exacerbate irritable bowel syndrome symptoms suggesting that mind-body interventions reducing arousal may prove beneficial. For many sufferers, symptoms can be traced to childhood and adolescence, making the early manifestation of irritable bowel syndrome important to understand. The current study will focus on young people aged 14-26 years with irritable bowel syndrome. The study will test the potential benefits of Iyengar yoga on clinical symptoms, psychospiritual functioning and visceral sensitivity. Yoga is thought to bring physical, psychological and spiritual benefits to practitioners and has been associated with reduced stress and pain. Through its focus on restoration and use of props, Iyengar yoga is especially designed to decrease arousal and promote psychospiritual resources in physically compromised individuals. An extensive and standardized teacher-training program support Iyengar yoga's reliability and safety. It is hypothesized that yoga will be feasible with less than 20% attrition; and the yoga group will demonstrate significantly improved outcomes compared to controls, with physiological and psychospiritual mechanisms contributing to improvements.
Methods/Design
Sixty irritable bowel syndrome patients aged 14-26 will be randomly assigned to a standardized 6-week twice weekly Iyengar yoga group-based program or a wait-list usual care control group. The groups will be compared on the primary clinical outcomes of irritable bowel syndrome symptoms, quality of life and global improvement at post-treatment and 2-month follow-up. Secondary outcomes will include visceral pain sensitivity assessed with a standardized laboratory task (water load task), functional disability and psychospiritual variables including catastrophizing, self-efficacy, mood, acceptance and mindfulness. Mechanisms of action involved in the proposed beneficial effects of yoga upon clinical outcomes will be explored, and include the mediating effects of visceral sensitivity, increased psychospiritual resources, regulated autonomic nervous system responses and regulated hormonal stress response assessed via salivary cortisol.
Trial registration
ClinicalTrials.gov NCT01107977.
doi:10.1186/1745-6215-12-15
PMCID: PMC3033835  PMID: 21244698
4.  Comparison of yoga versus stretching for chronic low back pain: protocol for the Yoga Exercise Self-care (YES) trial 
Trials  2010;11:36.
Background
Back pain, one of the most prevalent conditions afflicting American adults, is the leading reason for using complementary and alternative medicine (CAM) therapies. Yoga is an increasingly popular "mind-body" CAM therapy often used for relieving back pain and several small studies have found yoga effective for this condition. This study will assess whether yoga is effective for treating chronic low back pain compared with self care and exercise and will explore the mechanisms responsible for any observed benefits.
Methods/Design
A total of 210 participants with low back pain lasting at least 3 months will be recruited from primary care clinics of a large healthcare system based in Seattle. They will be randomized in a 2:2:1 ratio to receive 12 weekly yoga classes, 12 weekly conventional therapeutic exercise classes of comparable physical exertion, or a self-care book. Interviewers masked to participants' treatment group will assess outcomes at baseline and 6, 12 and 26 weeks after randomization. Primary outcomes will be back-related dysfunction and symptom bothersomeness. In addition, data will be collected on physical measurements (e.g., flexion) at baseline and 12 weeks and saliva samples will be obtained at baseline, 6 and 12 weeks. Information will be collected on specific physical, psychological, and physiological factors to allow exploration of possible mechanisms of action through which yoga could relieve back pain and dysfunction. The effectiveness of yoga will be assessed using analysis of covariance (using general estimating equations - GEE) within an intention-to-treat context. If yoga is found effective, further analyses will explore whether yoga's benefits are attributable to physical, psychological and/or physiological factors.
Conclusions
This study will provide the clearest evidence to date about the value of yoga as a therapeutic option for treating chronic back pain, and if the results are positive, will help focus future, more in-depth, research on the most promising potential mechanisms of action identified by this study.
Trial registration
This trial is registered in ClinicalTrials.gov, with the ID number of NCT00447668.
doi:10.1186/1745-6215-11-36
PMCID: PMC2864260  PMID: 20356395
5.  A randomized controlled trial examining Iyengar yoga for young adults with rheumatoid arthritis: a study protocol 
Trials  2011;12:19.
Background
Rheumatoid arthritis is a chronic, disabling disease that can compromise mobility, daily functioning, and health-related quality of life, especially in older adolescents and young adults. In this project, we will compare a standardized Iyengar yoga program for young people with rheumatoid arthritis to a standard care wait-list control condition.
Methods/Design
Seventy rheumatoid arthritis patients aged 16-35 years will be randomized into either the 6-week Iyengar yoga program (12 - 1.5 hour sessions twice weekly) or the 6-week wait-list control condition. A 20% attrition rate is anticipated. The wait-list group will receive the yoga program following completion of the first arm of the study. We will collect data quantitatively, using questionnaires and markers of disease activity, and qualitatively using semi-structured interviews. Assessments include standardized measures of general and arthritis-specific function, pain, mood, and health-related quality of life, as well as qualitative interviews, blood pressure/resting heart rate measurements, a medical exam and the assessment of pro-inflammatory cytokines. Data will be collected three times: before treatment, post-treatment, and two months following the treatment.
Discussion
Results from this study will provide critical data on non-pharmacologic methods for enhancing function in rheumatoid arthritis patients. In particular, results will shed light on the feasibility and potential efficacy of a novel intervention for rheumatoid arthritis symptoms, paving the way for a larger clinical trial.
Trial Registration
ClinicalTrials.gov NCT01096823
doi:10.1186/1745-6215-12-19
PMCID: PMC3033352  PMID: 21255431
6.  Impact and Outcomes of an Iyengar Yoga Program in a Cancer Centre 
Current Oncology  2008;15(Suppl 2):s109.es72-s109.es78.
Background
Individuals have increasingly sought complementary therapies to enhance health and well-being during cancer, although little evidence of their effect is available.
Objectives
We investigated how an Iyengar yoga program affects the self-identified worst symptom in a group of participants. whether quality of life, spiritual well-being, and mood disturbance change over the Iyengar yoga program and at 6 weeks after the program. how, from a participant’s perspective, the Iyengar yoga program complements conventional cancer treatment.
Patients and Methods
This pre–post instrumental collective case study used a mixed methods design and was conducted at a private Iyengar yoga studio. The sample consisted of 24 volunteers (23 women, 1 man; 88% Caucasian; mean age: 49 years) who were currently on treatment or who had been treated for cancer within the previous 6 months, and who participated in ten 90-minute weekly Iyengar yoga classes.
The main outcome measures were most-bothersome symptom (Measure Your Medical Outcome Profile 2 instrument), quality of life and spiritual well-being (Functional Assessment of Chronic Illness Therapy–General subscale and Spiritual subscale), and mood disturbance (Profile of Mood States–Short Form). Participant perspectives were obtained in qualitative interviews.
Results
Statistically significant improvements were reported in most-bothersome symptom (t(23) = 5.242; p < 0.001), quality of life (F(2,46) = 14.5; p < 0.001), spiritual well-being (F(2,46) = 14.4; p < 0.001), and mood disturbance (F(2,46) = 10.8; p < 0.001) during the program. At follow-up, quality of life (t(21) = −3.7; p = 0.001) and mood disturbance (t(21) = 2.4; p = 0.025) significantly improved over time. Categorical aggregation of the interview data showed that participants felt the program provided them with various benefits not included on the outcomes questionnaires.
Conclusions
Over the course of the Iyengar Yoga for Cancer program, participants reported an improvement in overall well-being. The program was also found to present participants with a holistic approach to care and to provide tools to effectively manage the demands of living with cancer and its treatment.
PMCID: PMC2528557  PMID: 18769575
Iyengar yoga; cancer; complementary and alternative medicine; integrative oncology; mixed methodology
7.  A pilot study of yoga as self-care for arthritis in minority communities 
Background
While arthritis is the most common cause of disability, non-Hispanic blacks and Hispanics experience worse arthritis impact despite having the same or lower prevalence of arthritis compared to non-Hispanic whites. People with arthritis who exercise regularly have less pain, more energy, and improved sleep, yet arthritis is one of the most common reasons for limiting physical activity. Mind-body interventions, such as yoga, that teach stress management along with physical activity may be well suited for investigation in both osteoarthritis and rheumatoid arthritis. Yoga users are predominantly white, female, and college educated. There are few studies that examine yoga in minority populations; none address arthritis. This paper presents a study protocol examining the feasibility and acceptability of providing yoga to an urban, minority population with arthritis.
Methods/design
In this ongoing pilot study, a convenience sample of 20 minority adults diagnosed with either osteoarthritis or rheumatoid arthritis undergo an 8-week program of yoga classes. It is believed that by attending yoga classes designed for patients with arthritis, with racially concordant instructors; acceptability of yoga as an adjunct to standard arthritis treatment and self-care will be enhanced. Self-care is defined as adopting behaviors that improve physical and mental well-being. This concept is quantified through collecting patient-reported outcome measures related to spiritual growth, health responsibility, interpersonal relations, and stress management. Additional measures collected during this study include: physical function, anxiety/depression, fatigue, sleep disturbance, social roles, and pain; as well as baseline demographic and clinical data. Field notes, quantitative and qualitative data regarding feasibility and acceptability are also collected. Acceptability is determined by response/retention rates, positive qualitative data, and continuing yoga practice after three months.
Discussion
There are a number of challenges in recruiting and retaining participants from a community clinic serving minority populations. Adopting behaviors that improve well-being and quality of life include those that integrate mental health (mind) and physical health (body). Few studies have examined offering integrative modalities to this population. This pilot was undertaken to quantify measures of feasibility and acceptability that will be useful when evaluating future plans for expanding the study of yoga in urban, minority populations with arthritis.
Trial registration
ClinicalTrials.gov: NCT01617421
doi:10.1186/1477-7525-11-55
PMCID: PMC3637098  PMID: 23548052
Yoga; Complementary and alternative medicine; Minority; Osteoarthritis; Rheumatoid arthritis; Self-efficacy
8.  Yoga Therapy Decreases Dyspnea-Related Distress and Improves Functional Performance in People with Chronic Obstructive Pulmonary Disease: A Pilot Study 
Background
There has been limited study of yoga training as a complementary exercise strategy to manage the symptom of dyspnea in patients with chronic obstructive pulmonary disease (COPD).
Purpose
The primary purpose of this pilot study was to evaluate a yoga program for its safety, feasibility, and efficacy for decreasing dyspnea intensity (DI) and dyspnea-related distress (DD) in older adults with COPD.
Methods
Clinically stable patients with COPD (n = 29; age 69.9 ± 9.5; forced expiratory volume in 1 second (FEV1) 47.7 ± 15.6% predicted; female = 21) were randomized to a 12-week yoga program specifically designed for people with COPD or usual-care control (UC). The twice-weekly yoga program included asanas (yoga postures) and visama vritti pranayama (timed breathing). Safety measure outcomes included heart rate, oxygen saturation, dyspnea, and pain. Feasibility was measured by patient-reported enjoyment, difficulty, and adherence to yoga sessions. At baseline and at 12 weeks, DI and DD were measured during incremental cycle ergometry and a 6-minute walk (6MW) test. Secondary efficacy outcomes included physical performance, psychologic well-being, and health-related quality of life (HRQoL).
Results
Yoga training was safe and feasible for patients with COPD. While yoga training had only small effects on DI after the 6MW test (effect size [ES], 0.20; p = 0.60), there were greater reductions in DD in the yoga group compared to UC (ES, 0.67; p = 0.08). Yoga training also improved 6MW distance (+71.7 ± 21.8 feet versus −27.6 ± 36.2 feet; ES = 0.78, p = 0.04) and self-reported functional performance (ES = 0.79, p = 0.04) compared to UC. There were small positive changes in muscle strength and HRQoL.
Conclusions
Elderly patients with COPD participated safely in a 12-week yoga program especially designed for patients with this chronic illness. After the program, the subjects tolerated more activity with less DD and improved their functional performance. These findings need to be confirmed in a larger, more sufficiently powered efficacy study.
doi:10.1089/acm.2008.0389
PMCID: PMC3051406  PMID: 19249998
9.  Yoga Therapy Decreases Dyspnea-Related Distress and Improves Functional Performance in People with Chronic Obstructive Pulmonary Disease: A Pilot Study 
Abstract
Background
There has been limited study of yoga training as a complementary exercise strategy to manage the symptom of dyspnea in patients with chronic obstructive pulmonary disease (COPD).
Purpose
The primary purpose of this pilot study was to evaluate a yoga program for its safety, feasibility, and efficacy for decreasing dyspnea intensity (DI) and dyspnea-related distress (DD) in older adults with COPD.
Methods
Clinically stable patients with COPD (n = 29; age 69.9 ± 9.5; forced expiratory volume in 1 second (FEV1) 47.7 ± 15.6% predicted; female = 21) were randomized to a 12-week yoga program specifically designed for people with COPD or usual-care control (UC). The twice-weekly yoga program included asanas (yoga postures) and visama vritti pranayama (timed breathing). Safety measure outcomes included heart rate, oxygen saturation, dyspnea, and pain. Feasibility was measured by patient-reported enjoyment, difficulty, and adherence to yoga sessions. At baseline and at 12 weeks, DI and DD were measured during incremental cycle ergometry and a 6-minute walk (6MW) test. Secondary efficacy outcomes included physical performance, psychologic well-being, and health-related quality of life (HRQoL).
Results
Yoga training was safe and feasible for patients with COPD. While yoga training had only small effects on DI after the 6MW test (effect size [ES], 0.20; p = 0.60), there were greater reductions in DD in the yoga group compared to UC (ES, 0.67; p = 0.08). Yoga training also improved 6MW distance (+71.7 ± 21.8 feet versus −27.6 ± 36.2 feet; ES = 0.78, p = 0.04) and self-reported functional performance (ES = 0.79, p = 0.04) compared to UC. There were small positive changes in muscle strength and HRQoL.
Conclusions
Elderly patients with COPD participated safely in a 12-week yoga program especially designed for patients with this chronic illness. After the program, the subjects tolerated more activity with less DD and improved their functional performance. These findings need to be confirmed in a larger, more sufficiently powered efficacy study.
doi:10.1089/acm.2008.0389
PMCID: PMC3051406  PMID: 19249998
10.  “Now I see a brighter day”: expectations and perceived benefits of an Iyengar yoga intervention for young patients with rheumatoid arthritis 
Rheumatoid arthritis (RA) is a chronic disease characterized by inflammation of joints and associated fatigue, deteriorated range of motion, and impaired psychosocial functioning. Young adults with RA are at a particular risk for compromised health-related quality of life, and there is a need for safe, effective complementary treatment in addition to traditional medical approaches. The aim of the present study was to use face-to-face participant interviews, conducted before and after an Iyengar yoga (IY) program, to examine mechanisms through which yoga may be beneficial to young adults with RA.
This pilot study utilized a single-arm design where all participants received the intervention. Classes were taught twice per week (1.5 hours each) for 6 weeks by an IY teacher qualified in therapeutics. Interview themes included participants’ baseline expectations about yoga and viewpoints as to how their functioning had been impacted by the IY intervention were examined. Five young adults with RA aged 24–31 years (mean = 28; 80% female) completed the yoga intervention. Participants consistently reported that yoga helped with energy, relaxation and mood and they discussed perceived mechanisms for how yoga impacted well-being. Mechanisms included physical changes such as range of motion and physiological awareness, and psychospiritual developments such as acceptance, coping, self-efficacy and mindfulness. Though the study is limited, participants’ responses provide compelling evidence that IY for RA patients is an intervention worthy of further exploration. The mechanisms and outcomes reported by participants support a biopsychosocial model, which proposes that yoga benefits patients through both physiological and psychospiritual changes.
doi:10.4172/2157-7595.1000101
PMCID: PMC3493157  PMID: 23145356
Iyengar yoga; Rheumatoid arthritis; Qualitative data
11.  Changes in pain intensity and health related quality of life with Iyengar yoga in nonspecific chronic low back pain: A randomized controlled study 
International Journal of Yoga  2014;7(1):48-53.
Background:
Nonspecific chronic low back (nCLBP) pain is prevalent among adult population and often leads to functional limitations, psychological symptoms, lower quality of life (QOL), and higher healthcare costs. The purpose of this study was to determine the efficacy of Iyengar yoga therapy on pain intensity and health related quality of life (HRQOL) with nCLBP.
Aim of the Study:
To compare the effect of Iyengar yoga therapy and conventional exercise therapy on pain intensity and HRQOL in nonspecific chronic low back pain.
Materials and Methods:
Experimental study with random sampling technique.
Subjects/Intervention:
Sixty subjects who fulfilled the selection criteria were randomly assigned to Iyengar yoga (yoga group, n = 30) and control group (exercise group, n = 30). Participants completed low back pain evaluation form and HRQOL-4 questionnaire before their intervention and again 4 weeks and 6 month later. Yoga group underwent 29 yogic postures training and exercise group had undergone general exercise program for 4 weeks.
Statistics:
Repeated measures analysis of variance (ANOVA) was used to analyze group differences over time, while controlling for baseline differences.
Results:
Patients in both groups experienced significant reduction in pain and improvement in HRQOL. In visual analogue scale (VAS) yoga group showed reduction of 72.81% (P = 0.001) as compared to exercise group 42.50% (P = 0.001). In HRQOL, yoga group showed reduction of 86.99% (P = 0.001) as compared to exercise group 67.66% (P = 0.001).
Conclusion:
These results suggest that Iyengar yoga provides better improvement in pain reduction and improvement in HRQOL in nonspecific chronic back pain than general exercise.
doi:10.4103/0973-6131.123481
PMCID: PMC4097916  PMID: 25035607
Health related quality of life; Iyengar yoga; nonspecific chronic low back pain; visual analog scale
12.  Treatment Preferences for CAM in Children with Chronic Pain 
CAM therapies have become increasingly popular in pediatric populations. Yet, little is known about children's preferences for CAM. This study examined treatment preferences in chronic pediatric pain patients offered a choice of CAM therapies for their pain. Participants were 129 children (94 girls) (mean age = 14.5 years ± 2.4; range = 8–18 years) presenting at a multidisciplinary, tertiary clinic specializing in pediatric chronic pain. Bivariate and multivariate analyses were used to examine the relationships between CAM treatment preferences and patient's sociodemographic and clinical characteristics, as well as their self-reported level of functioning. Over 60% of patients elected to try at least one CAM approach for pain. The most popular CAM therapies were biofeedback, yoga and hypnosis; the least popular were art therapy and energy healing, with craniosacral, acupuncture and massage being intermediate. Patients with a diagnosis of fibromyalgia (80%) were the most likely to try CAM versus those with other pain diagnoses. In multivariate analyses, pain duration emerged as a significant predictor of CAM preferences. For mind-based approaches (i.e. hypnosis, biofeedback and art therapy), pain duration and limitations in family activities were both significant predictors. When given a choice of CAM therapies, this sample of children with chronic pain, irrespective of pain diagnosis, preferred non-invasive approaches that enhanced relaxation and increased somatic control. Longer duration of pain and greater impairment in functioning, particularly during family activities increased the likelihood that such patients agreed to engage in CAM treatments, especially those that were categorized as mind-based modalities.
doi:10.1093/ecam/nel084
PMCID: PMC1978240  PMID: 17965769
functional impairment; mind–body approaches; pain management; pediatric pain; quality of life
13.  Peer mentorship to promote effective pain management in adolescents: study protocol for a randomised controlled trial 
Trials  2011;12:132.
Background
This protocol is for a study of a new program to improve outcomes in children suffering from chronic pain disorders, such as fibromyalgia, recurrent headache, or recurrent abdominal pain. Although teaching active pain self-management skills through cognitive-behavioral therapy (CBT) or a complementary program such as hypnotherapy or yoga has been shown to improve pain and functioning, children with low expectations of skill-building programs may lack motivation to comply with therapists' recommendations. This study will develop and test a new manualized peer-mentorship program which will provide modeling and reinforcement by peers to other adolescents with chronic pain (the mentored participants). The mentorship program will encourage mentored participants to engage in therapies that promote the learning of pain self-management skills and to support the mentored participants' practice of these skills. The study will examine the feasibility of this intervention for both mentors and mentored participants, and will assess the preliminary effectiveness of this program on mentored participants' pain and functional disability.
Methods
This protocol will recruit adolescents ages 12-17 with chronic pain and randomly assign them to either peer mentorship or a treatment-as-usual control group. Mentored participants will be matched with peer mentors of similar age (ages 14-18) who have actively participated in various treatment modalities through the UCLA Pediatric Pain Program and have learned to function successfully with a chronic pain disorder. The mentors will present information to mentored participants in a supervised and monitored telephone interaction for 2 months to encourage participation in skill-building programs. The control group will receive usual care but without the mentorship intervention. Mentored and control subjects' pain and functioning will be assessed at 2 months (end of intervention for mentored participants) and at 4 month follow-up to see if improvements persist. Measures of treatment adherence, pain, disability, and anxiety and depression will be assessed throughout study participation. Qualitative interviews for mentors, mentored participants, and control subjects will also be administered.
Trial registration
ClinicalTrials.gov NCT01118988.
doi:10.1186/1745-6215-12-132
PMCID: PMC3113991  PMID: 21600053
14.  Characteristics of Yoga Users: Results of a National Survey 
Journal of General Internal Medicine  2008;23(10):1653-1658.
Background
There are limited data on the characteristics of yoga users in the U.S.
Objective
To characterize yoga users, medical reasons for use, perceptions of helpfulness, and disclosure of use to medical professionals.
Methods
Utilizing cross-sectional survey data from the 2002 National Health Interview Survey (NHIS) Alternative Medicine Supplement (n = 31044), we examined correlates of yoga use for health. The estimated prevalence from 2002 NHIS of yoga for health was 5.1% corresponding to over 10 million adults.
Results
In 2002, yoga users were predominately Caucasian (85%) and female (76%) with a mean age of 39.5 years. Compared to non-yoga users, yoga users were more likely female (OR 3.76, 95% CI 3.11–4.33); less likely black than white (OR 0.65, 95% CI 0.53–0.80); tended to be younger; and more likely college educated (OR 2.70, 95% CI 2.37–3.08). Musculoskeletal conditions (OR 1.61, 95% CI 1.42–1.83), mental health conditions (OR 1.43, 95% CI 1.22–1.67), severe sprains in the last 12 months (OR 1.49, 95% CI 1.22–1.81), and asthma (OR 1.27, 95% CI 1.05–1.54) were independently associated with higher yoga use, while hypertension (OR 0.78, 95% CI 0.64–0.95) and chronic obstructive lung disease (OR 0.69, 95% CI 0.48–1.00) were associated with lower use. Yoga was most commonly used to treat musculoskeletal or mental health conditions, and most users reported yoga to be helpful for these conditions. A majority of yoga users (61%) felt yoga was important in maintaining health, though only 25% disclosed yoga practice to their medical professional.
Conclusions
We found that yoga users are more likely to be white, female, young and college educated. Yoga users report benefit for musculoskeletal conditions and mental health, indicating that further research on the efficacy of yoga for the treatment and/or prevention of these conditions is warranted.
doi:10.1007/s11606-008-0735-5
PMCID: PMC2533368  PMID: 18651193
yoga; complementary and alternative medicine (CAM); behavioral medicine
15.  A Novel Tool for the Assessment of Pain: Validation in Low Back Pain 
PLoS Medicine  2009;6(4):e1000047.
Joachim Scholz and colleagues develop and validate an assessment tool that distinguishes between radicular and axial low back pain.
Background
Adequate pain assessment is critical for evaluating the efficacy of analgesic treatment in clinical practice and during the development of new therapies. Yet the currently used scores of global pain intensity fail to reflect the diversity of pain manifestations and the complexity of underlying biological mechanisms. We have developed a tool for a standardized assessment of pain-related symptoms and signs that differentiates pain phenotypes independent of etiology.
Methods and Findings
Using a structured interview (16 questions) and a standardized bedside examination (23 tests), we prospectively assessed symptoms and signs in 130 patients with peripheral neuropathic pain caused by diabetic polyneuropathy, postherpetic neuralgia, or radicular low back pain (LBP), and in 57 patients with non-neuropathic (axial) LBP. A hierarchical cluster analysis revealed distinct association patterns of symptoms and signs (pain subtypes) that characterized six subgroups of patients with neuropathic pain and two subgroups of patients with non-neuropathic pain. Using a classification tree analysis, we identified the most discriminatory assessment items for the identification of pain subtypes. We combined these six interview questions and ten physical tests in a pain assessment tool that we named Standardized Evaluation of Pain (StEP). We validated StEP for the distinction between radicular and axial LBP in an independent group of 137 patients. StEP identified patients with radicular pain with high sensitivity (92%; 95% confidence interval [CI] 83%–97%) and specificity (97%; 95% CI 89%–100%). The diagnostic accuracy of StEP exceeded that of a dedicated screening tool for neuropathic pain and spinal magnetic resonance imaging. In addition, we were able to reproduce subtypes of radicular and axial LBP, underscoring the utility of StEP for discerning distinct constellations of symptoms and signs.
Conclusions
We present a novel method of identifying pain subtypes that we believe reflect underlying pain mechanisms. We demonstrate that this new approach to pain assessment helps separate radicular from axial back pain. Beyond diagnostic utility, a standardized differentiation of pain subtypes that is independent of disease etiology may offer a unique opportunity to improve targeted analgesic treatment.
Editors' Summary
Background
Pain, although unpleasant, is essential for survival. Whenever the body is damaged, nerve cells detecting the injury send an electrical message via the spinal cord to the brain and, as a result, action is taken to prevent further damage. Usually pain is short-lived, but sometimes it continues for weeks, months, or years. Long-lasting (chronic) pain can be caused by an ongoing, often inflammatory condition (for example, arthritis) or by damage to the nervous system itself—experts call this “neuropathic” pain. Damage to the brain or spinal cord causes central neuropathic pain; damage to the nerves that convey information from distant parts of the body to the spinal cord causes peripheral neuropathic pain. One example of peripheral neuropathic pain is “radicular” low back pain (also called sciatica). This is pain that radiates from the back into the legs. By contrast, axial back pain (the most common type of low back pain) is confined to the lower back and is non-neuropathic.
Why Was This Study Done?
Chronic pain is very common—nearly 10% of American adults have frequent back pain, for example—and there are many treatments for it, including rest, regulated exercise (physical therapy), pain-killing drugs (analgesics), and surgery. However, the best treatment for any individual depends on the exact nature of their pain, so it is important to assess their pain carefully before starting treatment. This is usually done by scoring overall pain intensity, but this assessment does not reflect the characteristics of the pain (for example, whether it occurs spontaneously or in response to external stimuli) or the complex biological processes involved in pain generation. An assessment designed to take such factors into account might improve treatment outcomes and could be useful in the development of new therapies. In this study, the researchers develop and test a new, standardized tool for the assessment of chronic pain that, by examining many symptoms and signs, aims to distinguish between pain subtypes.
What Did the Researchers Do and Find?
One hundred thirty patients with several types of peripheral neuropathic pain and 57 patients with non-neuropathic (axial) low back pain completed a structured interview of 16 questions and a standardized bedside examination of 23 tests. Patients were asked, for example, to choose words that described their pain from a list provided by the researchers and to grade the intensity of particular aspects of their pain from zero (no pain) to ten (the maximum imaginable pain). Bedside tests included measurements of responses to light touch, pinprick, and vibration—chronic pain often alters responses to harmless stimuli. Using “hierarchical cluster analysis,” the researchers identified six subgroups of patients with neuropathic pain and two subgroups of patients with non-neuropathic pain based on the patterns of symptoms and signs revealed by the interviews and physical tests. They then used “classification tree analysis” to identify the six questions and ten physical tests that discriminated best between pain subtypes and combined these items into a tool for a Standardized Evaluation of Pain (StEP). Finally, the researchers asked whether StEP, which took 10–15 minutes, could identify patients with radicular back pain and discriminate them from those with axial back pain in an independent group of 137 patients with chronic low back pain. StEP, they report, accurately diagnosed these two conditions and was well accepted by the patients.
What Do These Findings Mean?
These findings indicate that a standardized assessment of pain-related signs and symptoms can provide a simple, quick diagnostic procedure that distinguishes between radicular (neuropathic) and axial (non-neuropathic) low back pain. This distinction is crucial because these types of back pain are best treated in different ways. In addition, the findings suggest that it might be possible to identify additional pain subtypes using StEP. Because these subtypes may represent conditions in which different pain mechanisms are acting, classifying patients in this way might eventually enable physicians to tailor treatments for chronic pain to the specific needs of individual patients rather than, as at present, largely guessing which of the available treatments is likely to work best.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000047.
This study is further discussed in a PLoS Medicine Perspective by Giorgio Cruccu and and Andrea Truini
The US National Institute of Neurological Disorders and Stroke provides a primer on pain in English and Spanish
In its 2006 report on the health status of the US, the National Center for Health Statistics provides a special feature on the epidemiology of pain, including back pain
The Pain Treatment Topics Web site is a resource, sponsored partly by associations and manufacturers, that provides information on all aspects of pain and its treatment for health care professionals and their patients
Medline Plus provides a brief description of pain and of back pain and links to further information on both topics (in English and Spanish)
The MedlinePlus Medical Encyclopedia also has a page on low back pain (in English and Spanish)
doi:10.1371/journal.pmed.1000047
PMCID: PMC2661253  PMID: 19360087
16.  Yoga and pilates in the management of low back pain 
Many interventions for the management of low back pain exist, however most have modest efficacy at best, and there are few with clearly demonstrated benefits once pain becomes chronic. Therapeutic exercise, on the other hand, does appear to have significant benefits for managing patients with chronic low back pain (CLBP) in terms of decreasing pain and improving function. In addition, because chronic pain is complex and does not fit a simple model, there have also been numerous trials investigating and demonstrating the efficacy of multidisciplinary pain programs for CLBP. It follows that interventions that treat more than one aspect of LBP would have significant benefits for this patient population. Yoga and Pilates which have, both been gaining in popularity over the last decade are two mind–body exercise interventions that address both the physical and mental aspects of pain with core strengthening, flexibility, and relaxation. There has been a slow evolution of these nontraditional exercise regimens into treatment paradigms for LBP, although few studies examining their effects have been published. The following article will focus on the scientific and theoretical basis of using yoga and Pilates in the management of CLBP.
doi:10.1007/s12178-007-9004-1
PMCID: PMC2684152  PMID: 19468897
Low back pain; Yoga; Pilates; Therapeutic exercise; Core strengthening; Rehabilitation
17.  Neck pain 
BMJ Clinical Evidence  2008;2008:1103.
Introduction
Non-specific neck pain has a postural or mechanical basis and affects about two thirds of people at some stage, especially in middle age. Acute neck pain resolves within days or weeks, but may become chronic in about 10% of people. Whiplash injuries follow sudden acceleration–deceleration of the neck, such as in road traffic or sporting accidents. Up to 40% of people continue to report symptoms 15 years after the accident, although this varies between countries.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of treatments for people with non-specific neck pain without severe neurological deficit? What are the effects of treatments for acute whiplash injury? What are the effects of treatments for chronic whiplash injury? What are the effects of treatments for neck pain with radiculopathy? We searched: Medline, Embase, The Cochrane Library, and other important databases up to May 2007 (BMJ Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Results
We found 91 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of the evidence for interventions.
Conclusions
In this systematic review we present information relating to the effectiveness and safety of the following interventions: acupuncture, biofeedback, drug treatments (analgesics, antidepressants, epidural steroid injections, muscle relaxants, non-steroidal anti-inflammatory drugs [NSAIDs]), early mobilisation, early return to normal activity, exercise, heat or cold, manipulation (alone or plus exercise), mobilisation, multimodal treatment, patient education, percutaneous radiofrequency neurotomy, physical treatments, postural techniques (yoga, pilates, Alexander technique), pulsed electromagnetic field (PEMF) treatment, soft collars and special pillows, spray and stretch, surgery, traction, and transcutaneous electrical nerve stimulation (TENS).
Key Points
Non-specific neck pain has a postural or mechanical basis, and affects about two thirds of people at some stage, especially in middle age. Acute neck pain resolves within days or weeks, but becomes chronic in about 10% of people.Whiplash injuries follow sudden acceleration–deceleration of the neck, such as in road traffic or sporting accidents. Up to 40% of people continue to report symptoms 15 years after the accident.
The evidence about the effects of individual interventions for neck pain is often contradictory because of poor quality RCTs, the tendency for interventions to be given in combination, and for RCTs to be conducted in diverse groups. This lack of consistency in study design makes it difficult to isolate which intervention may be of use in which type of neck pain.
Stretching and strengthening exercise reduces chronic neck pain compared with usual care, either alone or in combination with manipulation, mobilisation, or infrared. Manipulation and mobilisation may reduce chronic pain more than usual care or less-active exercise. They seem likely to be as effective as each other or as exercise, and more effective than pulsed electromagnetic field (PEMF) treatment, or than heat treatment. Acupuncture may be more effective than some types of sham or inactive treatment at improving pain relief and quality of life at the end of treatment or in the short term.
Analgesics, NSAIDs, antidepressants, and muscle relaxants are widely used to treat chronic neck pain, but we don't know whether they are effective.
We don't know whether traction, PEMF treatment, TENS, heat or cold, biofeedback, spray and stretch, multimodal treatment, patient education, soft collars, or special pillows are better or worse than other treatments at reducing chronic neck pain.
Early mobilisation may reduce pain in people with acute whiplash injury compared with immobilisation or rest with a collar. We don't know whether exercise, early return tonormal activity, PEMF treatment, multimodal treatment, or drug treatment can reduce pain in people with acute whiplash injury.
We don't know whether percutaneous radiofrequency neurotomy, multimodal treatment, or physical treatment reduce pain in people with chronic whiplash injury.
We don't know whether surgery, analgesics, NSAIDs, muscle relaxants, or cervical epidural steroid injections reduce pain in people with neck pain plus radiculopathy.
PMCID: PMC2907992  PMID: 19445809
18.  18D. Yoga Promotes Relaxation in Children and Adolescents With Recurrent Headache 
Focus Areas: Integrative Approaches to Care, Supporting Behavioral Change, Alleviating Pain
Objective:
Recurrent headaches are prevalent in children and adolescents. Up to 89% of these individuals identify stress as a trigger. Yoga offers a complementary and alternative method for this population who often lacks effective relaxation tools for stress relief. This presentation describes the yoga group offered as part of the Integrative Headache Clinic (IHC) at Children's Hospital Colorado. One of the objectives is to determine the effect of the yoga group for children and adolescents with recurrent headaches on pain and relaxation scores.
Description:
Over the course of 18 months (January 2011 to June 2012), a retrospective chart review was conducted of 40 children and adolescents with an average age of 15 years, 62.5% of whom were female. During the first hour of clinic, every individual takes part in a 50-minute group yoga session consisting of 10 asanas that promote relaxation and pain relief. Before and after yoga group, participants rate their level of pain and relaxation on a scale from 0 to 10 (with 0 being no pain or relaxation and 10 being maximum pain or relaxation). The average “before yoga” pain score was 3.7 ( /- 3.0) and “after yoga” pain score was 3.4 ( /-3.1) (P=.0672), representing a decrease in pain. The average “before yoga” relaxation score was 5.2 ( /- 2.3) and “after yoga” relaxation score was 7.5 ( /-1.9) (P<.0001), representing a statistically significant increase in relaxation.
Results:
Group yoga is effective in promoting relaxation in children and adolescents with recurrent headache. Yoga may offer an adjunct to common pharmaceutical options for headache management for children and adolescents.
doi:10.7453/gahmj.2013.097CP.S18D
PMCID: PMC3875043
19.  Yoga vs. physical therapy vs. education for chronic low back pain in predominantly minority populations: study protocol for a randomized controlled trial 
Trials  2014;15:67.
Background
Chronic low back pain causes substantial morbidity and cost to society while disproportionately impacting low-income and minority adults. Several randomized controlled trials show yoga is an effective treatment. However, the comparative effectiveness of yoga and physical therapy, a common mainstream treatment for chronic low back pain, is unknown.
Methods/Design
This is a randomized controlled trial for 320 predominantly low-income minority adults with chronic low back pain, comparing yoga, physical therapy, and education. Inclusion criteria are adults 18–64 years old with non-specific low back pain lasting ≥12 weeks and a self-reported average pain intensity of ≥4 on a 0–10 scale. Recruitment takes place at Boston Medical Center, an urban academic safety-net hospital and seven federally qualified community health centers located in diverse neighborhoods. The 52-week study has an initial 12-week Treatment Phase where participants are randomized in a 2:2:1 ratio into i) a standardized weekly hatha yoga class supplemented by home practice; ii) a standardized evidence-based exercise therapy protocol adapted from the Treatment Based Classification method, individually delivered by a physical therapist and supplemented by home practice; and iii) education delivered through a self-care book. Co-primary outcome measures are 12-week pain intensity measured on an 11-point numerical rating scale and back-specific function measured using the modified Roland Morris Disability Questionnaire. In the subsequent 40-week Maintenance Phase, yoga participants are re-randomized in a 1:1 ratio to either structured maintenance yoga classes or home practice only. Physical therapy participants are similarly re-randomized to either five booster sessions or home practice only. Education participants continue to follow recommendations of educational materials. We will also assess cost effectiveness from the perspectives of the individual, insurers, and society using claims databases, electronic medical records, self-report cost data, and study records. Qualitative data from interviews will add subjective detail to complement quantitative data.
Trial registration
This trial is registered in ClinicalTrials.gov, with the ID number: NCT01343927.
doi:10.1186/1745-6215-15-67
PMCID: PMC3944007  PMID: 24568299
Complementary and Alternative Medicine; Cost effectiveness; Low back pain; Physical therapy; Randomized controlled trial; Yoga
20.  Yoga for chronic low back pain: A meta-analysis of randomized controlled trials 
OBJECTIVES
To evaluate the efficacy of yoga as an intervention for chronic low back pain (CLBP) using a meta-analytical approach. Randomized controlled trials (RCTs) that examined pain and/or functional disability as treatment outcomes were included. Post-treatment and follow-up outcomes were assessed.
METHODS:
A comprehensive search of relevant electronic databases, from the time of their inception until November 2011, was conducted. Cohen’s d effect sizes were calculated and entered in a random-effects model.
RESULTS:
Eight RCTs met the criteria for inclusion (eight assessing functional disability and five assessing pain) and involved a total of 743 patients. At post-treatment, yoga had a medium to large effect on functional disability (d=0.645) and pain (d=0.623). Despite a wide range of yoga styles and treatment durations, heterogeneity in post-treatment effect sizes was low. Follow-up effect sizes for functional disability and pain were smaller, but remained significant (d=0.397 and d=0.486, respectively); however, there was a moderate to high level of variability in these effect sizes.
DISCUSSION:
The results of the present study indicate that yoga may be an efficacious adjunctive treatment for CLBP. The strongest and most consistent evidence emerged for the short-term benefits of yoga on functional disability. However, before any definitive conclusions can be drawn, there are a number of methodological concerns that need to be addressed. In particular, it is recommended that future RCTs include an active control group to determine whether yoga has specific treatment effects and whether yoga offers any advantages over traditional exercise programs and other alternative therapies for CLBP.
PMCID: PMC3805350  PMID: 23894731
Chronic low back pain; Meta-analysis; Yoga
21.  A pragmatic multi-centred randomised controlled trial of yoga for chronic low back pain: Trial protocol 
A systematic review revealed three small randomised controlled trials of yoga for low back pain, all of which showed effects on back pain that favoured the yoga group. To build on these studies a larger trial, with longer term follow-up, and a number of different yoga teachers delivering the intervention is required. This study protocol describes the details of a randomised controlled trial (RCT) to determine the effectiveness and cost-effectiveness of Yoga for chronic Low Back Pain, which is funded by Arthritis Research Campaign (arc) and is being conducted by the University of York. 262 patients will be recruited from GP practices in 5 centres in England. Patients will be randomised to receive usual care or 12 weekly classes of yoga. A yoga programme will be devised that can be delivered by yoga teachers of the two main national yoga organisations in the UK (British Wheel of Yoga and Iyengar Yoga Association (UK)).
Trial registration: Current controlled trials registry ISRCTN81079604 (date registered 30/03/2007).
doi:10.1016/j.ctcp.2009.09.010
PMCID: PMC2856861  PMID: 20347837
Randomised; Trial; RCT; Yoga; Back; Pain
22.  Effects of Yoga Interventions on Fatigue: A Meta-Analysis 
Background. Researchers aimed at systematically reviewing and meta-analyzing the effectiveness of yoga interventions for fatigue. Methods. PubMed/Medline was searched until January 2012 for controlled clinical studies. Two reviewers independently extracted the data. The methodological quality of the studies was assessed. A meta-analysis was performed. Results. Nineteen clinical studies (total n = 948) were included in this review. Investigated yoga styles included Hatha, Iyengar, Asanas, Patanjali, Sahaja, and Tibetan yoga. Participants were suffering from cancer, multiple sclerosis, dialysis, chronic pancreatitis, fibromyalgia, asthma, or were healthy. Yoga had a small positive effect on fatigue (SMD = 0.27, 59% CI = 0.23–0.31). Seven studies received 4 points on the Jadad score. There were baseline differences in at least 5 studies. Conclusion. Overall, the effects of yoga interventions on fatigue were only small, particularly in cancer patients. Although yoga is generally a safe therapeutic intervention and effective to attenuate other health-related symptoms, this meta-analysis was not able to define the powerful effect of yoga on patients suffering from fatigue. Treatment effects of yoga could be improved in well-designed future studies. According to the GRADE recommendations assessing the overall quality of evidence, there is a moderate effect of the confidence placed in the estimates of the effects discussed here.
doi:10.1155/2012/124703
PMCID: PMC3443845  PMID: 22991569
23.  Yoga for Children and Young People’s Mental Health and Well-Being: Research Review and Reflections on the Mental Health Potentials of Yoga 
This article discusses yoga as a potential tool for children to deal with stress and regulate themselves. Yoga provides training of mind and body to bring emotional balance. We argue that children and young people need such tools to listen inward to their bodies, feelings, and ideas. Yoga may assist them in developing in sound ways, to strengthen themselves, and be contributing social beings. First, we address how children and young people in today’s world face numerous expectations and constant stimulation through the Internet and other media and communication technologies. One reason why children experience stress and mental health challenges is that globalization exposes the youth all over the world to various new demands, standards, and options. There is also increased pressure to succeed in school, partly due to increased competition but also a diverse range of options available for young people in contemporary times than in the past. Our argument also partially rests on the fact that modern society offers plenty of distractions and unwelcome attractions, especially linked to new media technologies. The dominant presence of multimedia devices and the time spent on them by children are clear indicators of the shift in lifestyles and priorities of our new generation. While these media technologies are valuable resources in children and young people’s lives for communication, learning, and entertainment, they also result in constant competition for youngster’s attention. A main concept in our article is that yoga may help children and young people cope with stress and thus, contribute positively to balance in life, well-being, and mental health. We present research literature suggesting that yoga improves children’s physical and mental well-being. Similarly, yoga in schools helps students improve resilience, mood, and self-regulation skills pertaining to emotions and stress.
doi:10.3389/fpsyt.2014.00035
PMCID: PMC3980104  PMID: 24765080
children; young people; mental health; well-being; yoga
24.  Isometric yoga improves the fatigue and pain of patients with chronic fatigue syndrome who are resistant to conventional therapy: a randomized, controlled trial 
Biopsychosocial Medicine  2014;8(1):27.
Background
Patients with chronic fatigue syndrome (CFS) often complain of persistent fatigue even after conventional therapies such as pharmacotherapy, cognitive behavioral therapy, or graded exercise therapy. The aim of this study was to investigate in a randomized, controlled trial the feasibility and efficacy of isometric yoga in patients with CFS who are resistant to conventional treatments.
Methods
This trial enrolled 30 patients with CFS who did not have satisfactory improvement after receiving conventional therapy for at least six months. They were randomly divided into two groups and were treated with either conventional pharmacotherapy (control group, n = 15) or conventional therapy together with isometric yoga practice that consisted of biweekly, 20-minute sessions with a yoga instructor and daily in-home sessions (yoga group, n = 15) for approximately two months. The short-term effect of isometric yoga on fatigue was assessed by administration of the Profile of Mood Status (POMS) questionnaire immediately before and after the final 20-minute session with the instructor. The long-term effect of isometric yoga on fatigue was assessed by administration of the Chalder’s Fatigue Scale (FS) questionnaire to both groups before and after the intervention. Adverse events and changes in subjective symptoms were recorded for subjects in the yoga group.
Results
All subjects completed the intervention. The mean POMS fatigue score decreased significantly (from 21.9 ± 7.7 to 13.8 ± 6.7, P < 0.001) after a yoga session. The Chalder’s FS score decreased significantly (from 25.9 ± 6.1 to 19.2 ± 7.5, P = 0.002) in the yoga group, but not in the control group. In addition to the improvement of fatigue, two patients with CFS and fibromyalgia syndrome in the yoga group also reported pain relief. Furthermore, many subjects reported that their bodies became warmer and lighter after practicing isometric yoga. Although there were no serious adverse events in the yoga group, two patients complained of tiredness and one of dizziness after the first yoga session with the instructor.
Conclusions
Isometric yoga as an add-on therapy is both feasible and successful at relieving the fatigue and pain of a subset of therapy-resistant patients with CFS.
Trial registration
University Hospital Medical Information Network (UMIN CTR) UMIN000009646.
doi:10.1186/s13030-014-0027-8
PMCID: PMC4269854  PMID: 25525457
Chronic fatigue syndrome; Isometric yoga; Fatigue; Treatment; Fibromyalgia
25.  Compliance effects in a randomised controlled trial of yoga for chronic low back pain: a methodological study 
Physiotherapy  2014;100(3):256-262.
Study design
Methodological study nested within a multicentre randomised controlled trial (RCT) of yoga plus usual general practitioner (GP) care vs usual GP care for chronic low back pain.
Objective
To explore the treatment effects of non-compliance using three approaches in an RCT evaluating yoga for low back pain.
Summary of background data
A large multicentre RCT using intention-to-treat (ITT) analysis found that participants with chronic low back pain who were offered a 12-week progressive programme of yoga plus usual GP care had better back function than those offered usual GP care alone. However, ITT analysis can underestimate the effect of treatment in those who comply with treatment. As such, the data were analysed using other approaches to assess the problem of non-compliance. The main outcome measure was the self-reported Roland Morris Disability Questionnaire (RMDQ).
Methods
Complier average causal effect (CACE) analysis, per-protocol analysis and on-treatment analysis were conducted on the data of participants who were fully compliant, predefined as attendance of at least three of the first six sessions and at least three other sessions. The analysis was repeated for participants who had attended at least one yoga session (i.e. any compliance), which included participants who were fully compliant. Each approach was described, including strengths and weaknesses, and the results of the different approaches were compared with those of the ITT analysis.
Results
For the participants who were fully compliant (n = 93, 60%), a larger beneficial treatment effect was seen using CACE analysis compared with per-protocol, on-treatment and ITT analyses at 3 and 12 months. The difference in mean change in RMDQ score between randomised groups was −3.30 [95% confidence interval (CI) −4.90 to −1.70, P < 0.001] at 3 months and −2.23 (95% CI −3.93 to −0.53, P = 0.010) at 12 months for CACE analysis, −3.12 (95% CI −4.26 to −1.98, P < 0.001) at 3 months and −2.11 (95% CI −3.33 to −0.89, P = 0.001) at 12 months for per-protocol analysis, and −2.91 (95% CI −4.06 to −1.76, P < 0.001) at 3 months and −2.10 (95% CI −3.31 to −0.89, P = 0.001) at 12 months for on-treatment analysis. For the participants who demonstrated any compliance (n = 133, 85%), the results were generally consistent with the fully compliant group at 3 months, but the treatment effect was smaller. The difference in mean change in RMDQ score between randomised groups was −2.45 (95% CI −3.67 to −1.24) for CACE analysis, −2.30 (95% CI −3.43 to 1.17) for per-protocol analysis and −2.15 (95% CI −3.25 to −1.06) for on-treatment analysis, which was slightly less than that for ITT analysis. In contrast, at 12 months, per-protocol and on-treatment analyses showed a larger treatment effect compared with CACE and ITT analyses: per protocol analysis −1.86 (95% CI −3.02 to −0.71), on-treatment analysis −1.99 (95% CI −3.13 to −0.86) and CACE analysis −1.67 (95% CI −2.95 to −0.40).
Conclusion
ITT analysis estimated a slightly smaller treatment effect in participants who complied with treatment. When examining compliance, CACE analysis is more rigorous than per-protocol and on-treatment analyses. Using CACE analysis, the treatment effect was larger in participants who complied with treatment compared with participants who were allocated to treatment, and the difference between ITT and CACE analyses for the fully compliant group at 3 months was small but clinically important. Per-protocol and on-treatment analyses may produce unreliable estimates when the effect of treatment is small.
International Standard Randomised Trial Number Register
ISRCTN 81079604.
doi:10.1016/j.physio.2013.10.001
PMCID: PMC4152624  PMID: 24530169
Compliance effects; CACE analysis; Per-protocol analysis; On-treatment analysis; Yoga; Low back pain

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