1 540 206 COMPLIANCE EFFECTS IN A RANDOMISED CONTROLLED TRIAL OF YOGA FOR CHRONIC LOW BACK PAIN: A METHODOLOGICAL STUDY. 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. 2014 2 2560 72 YOGA FOR CHRONIC LOW BACK PAIN: A RANDOMIZED TRIAL. BACKGROUND: PREVIOUS STUDIES INDICATE THAT YOGA MAY BE AN EFFECTIVE TREATMENT FOR CHRONIC OR RECURRENT LOW BACK PAIN. OBJECTIVE: TO COMPARE THE EFFECTIVENESS OF YOGA AND USUAL CARE FOR CHRONIC OR RECURRENT LOW BACK PAIN. DESIGN: PARALLEL-GROUP, RANDOMIZED, CONTROLLED TRIAL USING COMPUTER-GENERATED RANDOMIZATION CONDUCTED FROM APRIL 2007 TO MARCH 2010. OUTCOMES WERE ASSESSED BY POSTAL QUESTIONNAIRE. (INTERNATIONAL STANDARD RANDOMISED CONTROLLED TRIAL NUMBER REGISTER: ISRCTN 81079604) SETTING: 13 NON-NATIONAL HEALTH SERVICE PREMISES IN THE UNITED KINGDOM. PATIENTS: 313 ADULTS WITH CHRONIC OR RECURRENT LOW BACK PAIN. INTERVENTION: YOGA (N = 156) OR USUAL CARE (N = 157). ALL PARTICIPANTS RECEIVED A BACK PAIN EDUCATION BOOKLET. THE INTERVENTION GROUP WAS OFFERED A 12-CLASS, GRADUALLY PROGRESSING YOGA PROGRAM DELIVERED BY 12 TEACHERS OVER 3 MONTHS. MEASUREMENTS: SCORES ON THE ROLAND-MORRIS DISABILITY QUESTIONNAIRE (RMDQ) AT 3 (PRIMARY OUTCOME), 6, AND 12 (SECONDARY OUTCOMES) MONTHS; PAIN, PAIN SELF-EFFICACY, AND GENERAL HEALTH MEASURES AT 3, 6, AND 12 MONTHS (SECONDARY OUTCOMES). RESULTS: 93 (60%) PATIENTS OFFERED YOGA ATTENDED AT LEAST 3 OF THE FIRST 6 SESSIONS AND AT LEAST 3 OTHER SESSIONS. THE YOGA GROUP HAD BETTER BACK FUNCTION AT 3, 6, AND 12 MONTHS THAN THE USUAL CARE GROUP. THE ADJUSTED MEAN RMDQ SCORE WAS 2.17 POINTS (95% CI, 1.03 TO 3.31 POINTS) LOWER IN THE YOGA GROUP AT 3 MONTHS, 1.48 POINTS (CI, 0.33 TO 2.62 POINTS) LOWER AT 6 MONTHS, AND 1.57 POINTS (CI, 0.42 TO 2.71 POINTS) LOWER AT 12 MONTHS. THE YOGA AND USUAL CARE GROUPS HAD SIMILAR BACK PAIN AND GENERAL HEALTH SCORES AT 3, 6, AND 12 MONTHS, AND THE YOGA GROUP HAD HIGHER PAIN SELF-EFFICACY SCORES AT 3 AND 6 MONTHS BUT NOT AT 12 MONTHS. TWO OF THE 157 USUAL CARE PARTICIPANTS AND 12 OF THE 156 YOGA PARTICIPANTS REPORTED ADVERSE EVENTS, MOSTLY INCREASED PAIN. LIMITATION: THERE WERE MISSING DATA FOR THE PRIMARY OUTCOME (YOGA GROUP, N = 21; USUAL CARE GROUP, N = 18) AND DIFFERENTIAL MISSING DATA (MORE IN THE YOGA GROUP) FOR SECONDARY OUTCOMES. CONCLUSION: OFFERING A 12-WEEK YOGA PROGRAM TO ADULTS WITH CHRONIC OR RECURRENT LOW BACK PAIN LED TO GREATER IMPROVEMENTS IN BACK FUNCTION THAN DID USUAL CARE. PRIMARY FUNDING SOURCE: ARTHRITIS RESEARCH UK. 2011 3 2821 83 YOGA TREATMENT FOR CHRONIC NON-SPECIFIC LOW BACK PAIN. 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. 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 NON-PROFIT 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 SELF-ASSESSED. 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-LOW-CERTAINTY 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 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. 2017 4 2820 74 YOGA TREATMENT FOR CHRONIC NON-SPECIFIC LOW BACK PAIN (2017). WIELAND LS, SKOETZ N, PILKINGTON K, VEMPATI R, DADAMO CR, BERMAN BM. YOGA TREATMENT FOR CHRONIC NON-SPECIFIC LOW BACK PAIN.COCHRANE DATABASE SYST REV2017, ISSUE 1. ART. NO.: CD010671. DOI: 10.1002/14651858.CD010671.PUB2. 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. 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 NON-PROFIT 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 SELF-ASSESSED. 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% CI: -0.66 TO -0.14; CORRESPONDING TO A CHANGE IN THE ROLAND-MORRIS DISABILITY QUESTIONNAIRE OF MEAN DIFFERENCE (MD) = -2.18, 95% CI: -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% CI: -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% CI: -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: 2-8%]. 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% CI: -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% CI: -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-LOW-CERTAINTY 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% CI: -22.96 TO 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. 2017 5 518 46 COMPARING ONCE- VERSUS TWICE-WEEKLY YOGA CLASSES FOR CHRONIC LOW BACK PAIN IN PREDOMINANTLY LOW INCOME MINORITIES: A RANDOMIZED DOSING TRIAL. BACKGROUND. PREVIOUS STUDIES HAVE DEMONSTRATED THAT ONCE-WEEKLY YOGA CLASSES ARE EFFECTIVE FOR CHRONIC LOW BACK PAIN (CLBP) IN WHITE ADULTS WITH HIGH SOCIOECONOMIC STATUS. THE COMPARATIVE EFFECTIVENESS OF TWICE-WEEKLY CLASSES AND GENERALIZABILITY TO RACIALLY DIVERSE LOW INCOME POPULATIONS ARE UNKNOWN. METHODS. WE CONDUCTED A 12-WEEK RANDOMIZED, PARALLEL-GROUP, DOSING TRIAL FOR 95 ADULTS RECRUITED FROM AN URBAN SAFETY-NET HOSPITAL AND FIVE COMMUNITY HEALTH CENTERS COMPARING ONCE-WEEKLY (N = 49) VERSUS TWICE-WEEKLY (N = 46) STANDARDIZED YOGA CLASSES SUPPLEMENTED BY HOME PRACTICE. PRIMARY OUTCOMES WERE CHANGE FROM BASELINE TO 12 WEEKS IN PAIN (11-POINT SCALE) AND BACK-RELATED FUNCTION (23-POINT MODIFIED ROLAND-MORRIS DISABILITY QUESTIONNAIRE). RESULTS. 82% OF PARTICIPANTS WERE NONWHITE; 77% HAD ANNUAL HOUSEHOLD INCOMES <$40,000. THE SAMPLE'S BASELINE MEAN PAIN INTENSITY [6.9 (SD 1.6)] AND FUNCTION [13.7 (SD 5.0)] REFLECTED MODERATE TO SEVERE BACK PAIN AND IMPAIRMENT. PAIN AND BACK-RELATED FUNCTION IMPROVED WITHIN BOTH GROUPS (P < 0.001). HOWEVER, THERE WERE NO DIFFERENCES BETWEEN ONCE-WEEKLY AND TWICE-WEEKLY GROUPS FOR PAIN REDUCTION [-2.1 (95% CI -2.9, -1.3) VERSUS -2.4 (95% CI -3.1, -1.8), P = 0.62] OR BACK-RELATED FUNCTION [-5.1 (95% CI -7.0, -3.2) VERSUS -4.9 (95% CI -6.5, -3.3), P = 0.83]. CONCLUSIONS. TWELVE WEEKS OF ONCE-WEEKLY OR TWICE-WEEKLY YOGA CLASSES WERE SIMILARLY EFFECTIVE FOR PREDOMINANTLY LOW INCOME MINORITY ADULTS WITH MODERATE TO SEVERE CHRONIC LOW BACK PAIN. THIS TRIAL IS REGISTERED WITH CLINICALTRIALS.GOV NCT01761617. 2013 6 2852 53 YOGA, PHYSICAL THERAPY, OR EDUCATION FOR CHRONIC LOW BACK PAIN: A RANDOMIZED NONINFERIORITY TRIAL. BACKGROUND: YOGA IS EFFECTIVE FOR MILD TO MODERATE CHRONIC LOW BACK PAIN (CLBP), BUT ITS COMPARATIVE EFFECTIVENESS WITH PHYSICAL THERAPY (PT) IS UNKNOWN. MOREOVER, LITTLE IS KNOWN ABOUT YOGA'S EFFECTIVENESS IN UNDERSERVED PATIENTS WITH MORE SEVERE FUNCTIONAL DISABILITY AND PAIN. OBJECTIVE: TO DETERMINE WHETHER YOGA IS NONINFERIOR TO PT FOR CLBP. DESIGN: 12-WEEK, SINGLE-BLIND, 3-GROUP RANDOMIZED NONINFERIORITY TRIAL AND SUBSEQUENT 40-WEEK MAINTENANCE PHASE. (CLINICALTRIALS.GOV: NCT01343927). SETTING: ACADEMIC SAFETY-NET HOSPITAL AND 7 AFFILIATED COMMUNITY HEALTH CENTERS. PARTICIPANTS: 320 PREDOMINANTLY LOW-INCOME, RACIALLY DIVERSE ADULTS WITH NONSPECIFIC CLBP. INTERVENTION: PARTICIPANTS RECEIVED 12 WEEKLY YOGA CLASSES, 15 PT VISITS, OR AN EDUCATIONAL BOOK AND NEWSLETTERS. THE MAINTENANCE PHASE COMPARED YOGA DROP-IN CLASSES VERSUS HOME PRACTICE AND PT BOOSTER SESSIONS VERSUS HOME PRACTICE. MEASUREMENTS: PRIMARY OUTCOMES WERE BACK-RELATED FUNCTION, MEASURED BY THE ROLAND MORRIS DISABILITY QUESTIONNAIRE (RMDQ), AND PAIN, MEASURED BY AN 11-POINT SCALE, AT 12 WEEKS. PRESPECIFIED NONINFERIORITY MARGINS WERE 1.5 (RMDQ) AND 1.0 (PAIN). SECONDARY OUTCOMES INCLUDED PAIN MEDICATION USE, GLOBAL IMPROVEMENT, SATISFACTION WITH INTERVENTION, AND HEALTH-RELATED QUALITY OF LIFE. RESULTS: ONE-SIDED 95% LOWER CONFIDENCE LIMITS WERE 0.83 (RMDQ) AND 0.97 (PAIN), DEMONSTRATING NONINFERIORITY OF YOGA TO PT. HOWEVER, YOGA WAS NOT SUPERIOR TO EDUCATION FOR EITHER OUTCOME. YOGA AND PT WERE SIMILAR FOR MOST SECONDARY OUTCOMES. YOGA AND PT PARTICIPANTS WERE 21 AND 22 PERCENTAGE POINTS LESS LIKELY, RESPECTIVELY, THAN EDUCATION PARTICIPANTS TO USE PAIN MEDICATION AT 12 WEEKS. IMPROVEMENTS IN YOGA AND PT GROUPS WERE MAINTAINED AT 1 YEAR WITH NO DIFFERENCES BETWEEN MAINTENANCE STRATEGIES. FREQUENCY OF ADVERSE EVENTS, MOSTLY MILD SELF-LIMITED JOINT AND BACK PAIN, DID NOT DIFFER BETWEEN THE YOGA AND PT GROUPS. LIMITATIONS: PARTICIPANTS WERE NOT BLINDED TO TREATMENT ASSIGNMENT. THE PT GROUP HAD DISPROPORTIONATE LOSS TO FOLLOW-UP. CONCLUSION: A MANUALIZED YOGA PROGRAM FOR NONSPECIFIC CLBP WAS NONINFERIOR TO PT FOR FUNCTION AND PAIN. PRIMARY FUNDING SOURCE: NATIONAL CENTER FOR COMPLEMENTARY AND INTEGRATIVE HEALTH OF THE NATIONAL INSTITUTES OF HEALTH. 2017 7 1215 44 EXPLORING THE EFFECTS OF YOGA THERAPY ON HEART RATE VARIABILITY AND PATIENT-REPORTED OUTCOMES AFTER CANCER TREATMENT: A STUDY PROTOCOL. BACKGROUND: FOLLOWING CANCER TREATMENT, ADULTS COMMONLY REPORT WORSENED PATIENT-REPORTED OUTCOMES (PROS) SUCH AS ANXIETY, STRESS, DEPRESSION, PERSISTENT AND UPSETTING COGNITIVE COMPLAINTS, UNRELENTING FATIGUE, AND REDUCED QUALITY OF LIFE. POORER PROS ARE ASSOCIATED WITH DISRUPTED AUTONOMIC NERVOUS SYSTEM FUNCTIONING AS MEASURED BY HEART RATE VARIABILITY (HRV), BOTH OF WHICH HAVE BEEN ASSOCIATED WITH GREATER MORBIDITY AND MORTALITY. INTERVENTIONS TO IMPROVE HRV AND PROS AMONG ADULTS FOLLOWING CANCER TREATMENT ARE NEEDED. YOGA THERAPY HOLDS PROMISE AS AN INTERVENTION TO IMPROVE HRV AND PROS. THEREFORE, WE CONDUCTED A SINGLE-SUBJECT EXPLORATORY EXPERIMENTAL STUDY TO INVESTIGATE THE EFFECTS OF YOGA THERAPY ON HRV AND SPECIFIC PROS (IE, CANCER-RELATED FATIGUE, ANXIETY, COGNITIVE FUNCTION, DEPRESSION, STRESS, QUALITY OF LIFE) IN ADULTS TREATED FOR CANCER. TO REDUCE PUBLICATION BIAS, IMPROVE REPRODUCIBILITY, AND SERVE AS A REFERENCE FOR FORTHCOMING REPORTING OF STUDY RESULTS, WE PRESENT THE STUDY PROTOCOL FOR THIS STUDY HEREIN. METHODS: PARTICIPANTS WERE ADULTS WHO COMPLETED CANCER TREATMENT THAT WERE RECRUITED FROM THE OTTAWA INTEGRATIVE CANCER CENTRE. CONSENTING AND ELIGIBLE PARTICIPANTS RECEIVED ONE 1:1 YOGA THERAPY SESSION (IE, 1 PARTICIPANT, 1 YOGA THERAPIST) AND 6 WEEKLY GROUP-BASED YOGA THERAPY SESSIONS (IE, 2-3 PARTICIPANTS, 1 YOGA THERAPIST). PARTICIPANTS COMPLETED ASSESSMENTS 7 TIMES: 3 TIMES PRIOR TO THE PROGRAM (IE, -6 WEEKS, -3 WEEKS, IMMEDIATELY PRIOR TO THE 1:1 YOGA THERAPY SESSION), IMMEDIATELY FOLLOWING THE 1:1 YOGA THERAPY SESSION, PRIOR TO THE FIRST GROUP-BASED YOGA THERAPY SESSION, AFTER THE LAST GROUP-BASED YOGA THERAPY SESSION, AND AT A 6-WEEK FOLLOW-UP. HIERARCHICAL LINEAR MODELING WILL BE USED TO TEST THE AVERAGE EFFECTS OF THE YOGA THERAPY PROGRAM ACROSS PARTICIPANTS. DISCUSSION: THIS STUDY WILL EXPLORE SEVERAL NOVEL HYPOTHESES, INCLUDING WHETHER YOGA THERAPY CAN IMPROVE HRV AND/OR SPECIFIC PROS AMONG ADULTS TREATED FOR CANCER ACUTELY (IE, DURING A 1:1 YOGA THERAPY SESSION) AND/OR THROUGH REPEATED EXPOSURE (IE, AFTER COMPLETING 6 WEEKS OF GROUP-BASED YOGA THERAPY). ALTHOUGH THE FINDINGS WILL REQUIRE CONFIRMATION OR REFUTATION IN FUTURE TRIALS, THEY MAY PROVIDE INITIAL EVIDENCE THAT YT MAY BENEFIT ADULTS TREATED FOR CANCER. TRIAL REGISTRATION: ISRCTN REGISTRY, ISRCTN64763228. REGISTERED ON DECEMBER 12, 2021. THIS TRIAL WAS REGISTERED RETROSPECTIVELY. URL OF TRIAL REGISTRY RECORD: HTTPS://WWW.ISRCTN.COM/ISRCTN64763228. 2022 8 2831 46 YOGA VS. PHYSICAL THERAPY VS. EDUCATION FOR CHRONIC LOW BACK PAIN IN PREDOMINANTLY MINORITY POPULATIONS: STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL. 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. 2014 9 2518 67 YOGA COMPARED TO NON-EXERCISE OR PHYSICAL THERAPY EXERCISE ON PAIN, DISABILITY, AND QUALITY OF LIFE FOR PATIENTS WITH CHRONIC LOW BACK PAIN: A SYSTEMATIC REVIEW AND META-ANALYSIS OF RANDOMIZED CONTROLLED TRIALS. BACKGROUND: CHRONIC LOW BACK PAIN (CLBP) IS A COMMON AND OFTEN DISABLING MUSCULOSKELETAL CONDITION. YOGA HAS BEEN PROVEN TO BE AN EFFECTIVE THERAPY FOR CHRONIC LOW BACK PAIN. HOWEVER, THERE ARE STILL CONTROVERSIES ABOUT THE EFFECTS OF YOGA AT DIFFERENT FOLLOW-UP PERIODS AND COMPARED WITH OTHER PHYSICAL THERAPY EXERCISES. OBJECTIVE: TO CRITICALLY COMPARE THE EFFECTS OF YOGA FOR PATIENTS WITH CHRONIC LOW BACK PAIN ON PAIN, DISABILITY, QUALITY OF LIFE WITH NON-EXERCISE (E.G. USUAL CARE, EDUCATION), PHYSICAL THERAPY EXERCISE. METHODS: THIS STUDY WAS REGISTERED IN PROSPERO, AND THE REGISTRATION NUMBER WAS CRD42020159865. RANDOMIZED CONTROLLED TRIALS (RCTS) OF ONLINE DATABASES INCLUDED PUBMED, WEB OF SCIENCE, COCHRANE CENTRAL REGISTER OF CONTROLLED TRIALS, EMBASE WHICH EVALUATED EFFECTS OF YOGA FOR PATIENTS WITH CHRONIC LOW BACK PAIN ON PAIN, DISABILITY, AND QUALITY OF LIFE WERE SEARCHED FROM INCEPTION TIME TO NOVEMBER 1, 2019. STUDIES WERE ELIGIBLE IF THEY ASSESSED AT LEAST ONE IMPORTANT OUTCOME, NAMELY PAIN, BACK-SPECIFIC DISABILITY, QUALITY OF LIFE. THE COCHRANE RISK OF BIAS TOOL WAS USED TO ASSESS THE METHODOLOGICAL QUALITY OF INCLUDED RANDOMIZED CONTROLLED TRIALS. THE CONTINUOUS OUTCOMES WERE ANALYZED BY CALCULATING THE MEAN DIFFERENCE (MD) OR STANDARDIZED MEAN DIFFERENCE (SMD) WITH 95% CONFIDENCE INTERVALS (CI) ACCORDING TO WHETHER COMBINING OUTCOMES MEASURED ON DIFFERENT SCALES OR NOT. RESULTS: A TOTAL OF 18 RANDOMIZED CONTROLLED TRIALS WERE INCLUDED IN THIS META-ANALYSIS. YOGA COULD SIGNIFICANTLY REDUCE PAIN AT 4 TO 8 WEEKS (MD = -0.83, 95% CI = -1.19 TO -0.48, P<0.00001, I2 = 0%), 3 MONTHS (MD = -0.43, 95% CI = -0.64 TO -0.23, P<0.0001, I2 = 0%), 6 TO 7 MONTHS (MD = -0.56, 95% CI = -1.02 TO -0.11, P = 0.02, I2 = 50%), AND WAS NOT SIGNIFICANT IN 12 MONTHS (MD = -0.52, 95% CI = -1.64 TO 0.59, P = 0.36, I2 = 87%) COMPARED WITH NON-EXERCISE. YOGA WAS BETTER THAN NON-EXERCISE ON DISABILITY AT 4 TO 8 WEEKS (SMD = -0.30, 95% CI = -0.51 TO -0.10, P = 0.003, I2 = 0%), 3 MONTHS (SMD = -0.31, 95% CI = -0.45 TO -0.18, P<0.00001, I2 = 30%), 6 MONTHS (SMD = -0.38, 95% CI = -0.53 TO -0.23, P<0.00001, I2 = 0%), 12 MONTHS (SMD = -0.33, 95% CI = -0.54 TO -0.12, P = 0.002, I2 = 9%). THERE WAS NO SIGNIFICANT DIFFERENCE ON PAIN, DISABILITY COMPARED WITH PHYSICAL THERAPY EXERCISE GROUP. FURTHERMORE, IT SUGGESTED THAT THERE WAS A NON-SIGNIFICANT DIFFERENCE ON PHYSICAL AND MENTAL QUALITY OF LIFE BETWEEN YOGA AND ANY OTHER INTERVENTIONS. CONCLUSION: THIS META-ANALYSIS PROVIDED EVIDENCE FROM VERY LOW TO MODERATE INVESTIGATING THE EFFECTIVENESS OF YOGA FOR CHRONIC LOW BACK PAIN PATIENTS AT DIFFERENT TIME POINTS. YOGA MIGHT DECREASE PAIN FROM SHORT TERM TO INTERMEDIATE TERM AND IMPROVE FUNCTIONAL DISABILITY STATUS FROM SHORT TERM TO LONG TERM COMPARED WITH NON-EXERCISE (E.G. USUAL CARE, EDUCATION). YOGA HAD THE SAME EFFECT ON PAIN AND DISABILITY AS ANY OTHER EXERCISE OR PHYSICAL THERAPY. YOGA MIGHT NOT IMPROVE THE PHYSICAL AND MENTAL QUALITY OF LIFE BASED ON THE RESULT OF A MERGING. 2020 10 1699 47 PARTICIPANT CHARACTERISTICS ASSOCIATED WITH SYMPTOMATIC IMPROVEMENT FROM YOGA FOR CHRONIC LOW BACK PAIN. CONTEXT: STUDIES SUGGEST THAT YOGA IS EFFECTIVE FOR MODERATE TO SEVERE CHRONIC LOW BACK PAIN (CLBP) IN DIVERSE PREDOMINANTLY LOWER SOCIOECONOMIC STATUS POPULATIONS. HOWEVER, LITTLE IS KNOWN ABOUT FACTORS ASSOCIATED WITH BENEFIT FROM THE YOGA INTERVENTION. OBJECTIVE: IDENTIFY FACTORS AT BASELINE INDEPENDENTLY ASSOCIATED WITH GREATER EFFICACY AMONG PARTICIPANTS IN A STUDY OF YOGA FOR CLBP. DESIGN: FROM SEPTEMBER-DECEMBER 2011, A 12-WEEK RANDOMIZED DOSING TRIAL WAS CONDUCTED COMPARING WEEKLY VS. TWICE-WEEKLY 75-MINUTE HATHA YOGA CLASSES FOR 95 PREDOMINANTLY LOW-INCOME MINORITY ADULTS WITH NONSPECIFIC CLBP. PARTICIPANT CHARACTERISTICS COLLECTED AT BASELINE WERE USED TO DETERMINE FACTORS BEYOND TREATMENT ASSIGNMENT (REPORTED IN THE INITIAL STUDY) THAT PREDICTED OUTCOME. WE USED BIVARIATE TESTING TO IDENTIFY BASELINE CHARACTERISTICS ASSOCIATED WITH IMPROVEMENT IN FUNCTION AND PAIN, AND INCLUDED SELECT FACTORS IN A MULTIVARIATE LINEAR REGRESSION. SETTING: RECRUITMENT AND CLASSES OCCURRED IN AN ACADEMIC SAFETY-NET HOSPITAL AND FIVE AFFILIATED COMMUNITY HEALTH CENTERS IN BOSTON, MASSACHUSETTS. PARTICIPANTS: NINETY-FIVE ADULTS WITH NONSPECIFIC CLBP, AGES RANGING FROM 20-64 (MEAN 48) YEARS; 72 WOMEN AND 23 MEN. OUTCOME MEASURES: PRIMARY OUTCOMES WERE CHANGES IN BACK-RELATED FUNCTION (MODIFIED ROLAND-MORRIS DISABILITY QUESTIONNAIRE, RMDQ; 0-23) AND MEAN LOW BACK PAIN INTENSITY (0-10) IN THE PREVIOUS WEEK, FROM BASELINE TO WEEK 12. RESULTS: ADJUSTING FOR GROUP ASSIGNMENT, BASELINE RMDQ, AGE, AND GENDER, FOREIGN NATIONALITY AND LOWER BASELINE SF36 PHYSICAL COMPONENT SCORE (PCS) WERE INDEPENDENTLY ASSOCIATED WITH IMPROVEMENT IN RMDQ. GREATER THAN HIGH SCHOOL EDUCATION LEVEL, CLBP LESS THAN 1 YEAR, AND LOWER BASELINE SF36 PCS WERE INDEPENDENTLY ASSOCIATED WITH IMPROVEMENT IN PAIN INTENSITY. OTHER DEMOGRAPHICS INCLUDING RACE, INCOME, GENDER, BMI, AND USE OF PAIN MEDICATIONS WERE NOT ASSOCIATED WITH EITHER OUTCOME. CONCLUSIONS: POOR PHYSICAL HEALTH AT BASELINE IS ASSOCIATED WITH GREATER IMPROVEMENT FROM YOGA IN BACK-RELATED FUNCTION AND PAIN. RACE, INCOME, AND BODY MASS INDEX DO NOT AFFECT THE POTENTIAL FOR A PERSON WITH LOW BACK PAIN TO EXPERIENCE BENEFIT FROM YOGA. 2014 11 162 62 A RANDOMISED CONTROLLED TRIAL OF YOGA FOR THE TREATMENT OF CHRONIC LOW BACK PAIN: RESULTS OF A PILOT STUDY. OBJECTIVE: TO CONDUCT A PILOT TRIAL OF YOGA FOR THE TREATMENT OF CHRONIC LOW BACK PAIN (LBP) TO INFORM THE FEASIBILITY AND PRACTICALITY OF CONDUCTING A FULL-SCALE TRIAL IN THE UK; AND TO ASSESS THE EFFICACY OF YOGA FOR THE TREATMENT OF CHRONIC LOW BACK PAIN. DESIGN: A PRAGMATIC RANDOMISED CONTROLLED TRIAL WAS UNDERTAKEN COMPARING YOGA TO USUAL CARE. PARTICIPANTS: TWENTY PARTICIPANTS WHO HAD PRESENTED TO THEIR GP WITH CHRONIC LOW BACK PAIN IN THE PREVIOUS 18 MONTHS WERE RECRUITED VIA GP RECORDS FROM ONE PRACTICE IN YORK, UK. INTERVENTIONS: TWENTY PATIENTS WERE RANDOMISED TO EITHER 12 WEEKLY 75-MIN SESSIONS OF SPECIALISED YOGA PLUS WRITTEN ADVICE, OR USUAL CARE PLUS WRITTEN ADVICE. ALLOCATION WAS 50/50. MAIN OUTCOME MEASURES: RECRUITMENT RATE, LEVELS OF INTERVENTION ATTENDANCE, AND LOSS TO FOLLOW-UP WERE THE MAIN NON-CLINICAL OUTCOMES. CHANGE AS MEASURED BY THE ROLAND AND MORRIS DISABILITY QUESTIONNAIRE WAS THE PRIMARY CLINICAL OUTCOME. CHANGES IN THE ABERDEEN BACK PAIN SCALE, SF-12, EQ-5D, AND PAIN SELF-EFFICACY WERE SECONDARY CLINICAL OUTCOMES. DATA WERE COLLECTED VIA POSTAL QUESTIONNAIRE AT BASELINE, 4 WEEKS, AND 12 WEEKS FOLLOW-UP. RESULTS: OF THE 286 PATIENTS IDENTIFIED FROM THE GP DATABASE, 52 (18%) CONSENTED AND RETURNED THE ELIGIBILITY QUESTIONNAIRE, OUT OF THESE 20 (6.9%) WERE ELIGIBLE AND RANDOMISED. THE TOTAL PERCENTAGE OF PATIENTS RANDOMISED FROM THE GP PRACTICE POPULATION WAS 0.28%. TEN PATIENTS WERE RANDOMISED TO YOGA, RECEIVING AN AVERAGE OF 1.7 SESSIONS (RANGE 0-5), AND 10 WERE RANDOMISED TO USUAL CARE. AT 12 WEEKS FOLLOW-UP DATA WAS RECEIVED FROM 60% OF PATIENTS IN THE YOGA GROUP AND 90% OF PATIENTS IN THE USUAL CARE GROUP (75% OVERALL). NO SIGNIFICANT DIFFERENCES WERE SEEN BETWEEN GROUPS IN CLINICAL OUTCOMES APART FROM ON THE ABERDEEN BACK PAIN SCALE AT FOUR WEEKS FOLLOW-UP WHERE THE YOGA GROUP REPORTED SIGNIFICANTLY LESS PAIN. CONCLUSION: THIS PILOT STUDY PROVIDED USEFUL DATA AND INFORMATION TO INFORM THE DESIGN AND DEVELOPMENT OF A FULL-SCALE TRIAL OF YOGA FOR CLBP IN THE UK. A KEY FINDING IS THE CALCULATION OF GP PRACTICE TOTAL LIST SIZE REQUIRED FOR PATIENT RECRUITMENT IN A FULL-SCALE TRIAL, AND THE NEED TO IMPLEMENT METHODS TO INCREASE CLASS ATTENDANCE. 2010 12 521 57 COMPARING YOGA, EXERCISE, AND A SELF-CARE BOOK FOR CHRONIC LOW BACK PAIN: A RANDOMIZED, CONTROLLED TRIAL. BACKGROUND: CHRONIC LOW BACK PAIN IS A COMMON PROBLEM THAT HAS ONLY MODESTLY EFFECTIVE TREATMENT OPTIONS. OBJECTIVE: TO DETERMINE WHETHER YOGA IS MORE EFFECTIVE THAN CONVENTIONAL THERAPEUTIC EXERCISE OR A SELF-CARE BOOK FOR PATIENTS WITH CHRONIC LOW BACK PAIN. DESIGN: RANDOMIZED, CONTROLLED TRIAL. SETTING: A NONPROFIT, INTEGRATED HEALTH CARE SYSTEM. PATIENTS: 101 ADULTS WITH CHRONIC LOW BACK PAIN. INTERVENTION: 12-WEEK SESSIONS OF YOGA OR CONVENTIONAL THERAPEUTIC EXERCISE CLASSES OR A SELF-CARE BOOK. MEASUREMENTS: PRIMARY OUTCOMES WERE BACK-RELATED FUNCTIONAL STATUS (MODIFIED 24-POINT ROLAND DISABILITY SCALE) AND "BOTHERSOMENESS" OF PAIN (11-POINT NUMERICAL SCALE). THE PRIMARY TIME POINT WAS 12 WEEKS. CLINICALLY SIGNIFICANT CHANGE WAS CONSIDERED TO BE 2.5 POINTS ON THE FUNCTIONAL STATUS SCALE AND 1.5 POINTS ON THE BOTHERSOMENESS SCALE. SECONDARY OUTCOMES WERE DAYS OF RESTRICTED ACTIVITY, GENERAL HEALTH STATUS, AND MEDICATION USE. RESULTS: AFTER ADJUSTMENT FOR BASELINE VALUES, BACK-RELATED FUNCTION IN THE YOGA GROUP WAS SUPERIOR TO THE BOOK AND EXERCISE GROUPS AT 12 WEEKS (YOGA VS. BOOK: MEAN DIFFERENCE, -3.4 [95% CI, -5.1 TO - 1.6] [P < 0.001]; YOGA VS. EXERCISE: MEAN DIFFERENCE, -1.8 [CI, -3.5 TO - 0.1] [P = 0.034]). NO SIGNIFICANT DIFFERENCES IN SYMPTOM BOTHERSOMENESS WERE FOUND BETWEEN ANY 2 GROUPS AT 12 WEEKS; AT 26 WEEKS, THE YOGA GROUP WAS SUPERIOR TO THE BOOK GROUP WITH RESPECT TO THIS MEASURE (MEAN DIFFERENCE, -2.2 [CI, -3.2 TO - 1.2]; P < 0.001). AT 26 WEEKS, BACK-RELATED FUNCTION IN THE YOGA GROUP WAS SUPERIOR TO THE BOOK GROUP (MEAN DIFFERENCE, -3.6 [CI, -5.4 TO - 1.8]; P < 0.001). LIMITATIONS: PARTICIPANTS IN THIS STUDY WERE FOLLOWED FOR ONLY 26 WEEKS AFTER RANDOMIZATION. ONLY 1 INSTRUCTOR DELIVERED EACH INTERVENTION. CONCLUSIONS: YOGA WAS MORE EFFECTIVE THAN A SELF-CARE BOOK FOR IMPROVING FUNCTION AND REDUCING CHRONIC LOW BACK PAIN, AND THE BENEFITS PERSISTED FOR AT LEAST SEVERAL MONTHS. 2005 13 2851 53 YOGA, PHYSICAL THERAPY, AND BACK PAIN EDUCATION FOR SLEEP QUALITY IN LOW-INCOME RACIALLY DIVERSE ADULTS WITH CHRONIC LOW BACK PAIN: A SECONDARY ANALYSIS OF A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: POOR SLEEP IS COMMON AMONG ADULTS WITH CHRONIC LOW BACK PAIN (CLBP), BUT THE INFLUENCE OF CLBP TREATMENTS, SUCH AS YOGA AND PHYSICAL THERAPY (PT), ON SLEEP QUALITY IS UNDER STUDIED. OBJECTIVE: EVALUATE THE EFFECTIVENESS OF YOGA AND PT FOR IMPROVING SLEEP QUALITY IN ADULTS WITH CLBP. DESIGN: SECONDARY ANALYSIS OF A RANDOMIZED CONTROLLED TRIAL. SETTING: ACADEMIC SAFETY-NET HOSPITAL AND 7 AFFILIATED COMMUNITY HEALTH CENTERS. PARTICIPANTS: A TOTAL OF 320 ADULTS WITH CLBP. INTERVENTION: TWELVE WEEKLY YOGA CLASSES, 1-ON-1 PT SESSIONS, OR AN EDUCATIONAL BOOK. MAIN MEASURES: SLEEP QUALITY WAS MEASURED USING THE PITTSBURGH SLEEP QUALITY INDEX (PSQI) GLOBAL SCORE (0-21) AT BASELINE, 12 WEEKS, AND 52 WEEKS. ADDITIONALLY, WE ALSO EVALUATED HOW THE PROPORTION OF PARTICIPANTS WHO ACHIEVED A CLINICALLY MEANINGFUL IMPROVEMENT IN SLEEP QUALITY (> 3-POINT REDUCTION IN PSQI) AT 12 WEEKS VARIED BY CHANGES IN PAIN AND PHYSICAL FUNCTION AT 6 WEEKS. KEY RESULTS: AMONG PARTICIPANTS (MEAN AGE = 46.0, 64% FEMALE, 82% NON-WHITE), NEARLY ALL (92%) REPORTED POOR SLEEP QUALITY (PSQI > 5) AT BASELINE. AT 12 WEEKS, MODEST IMPROVEMENTS IN SLEEP QUALITY WERE OBSERVED AMONG THE YOGA (PSQI MEAN DIFFERENCE [MD] = - 1.19, 95% CONFIDENCE INTERVAL [CI] - 1.82, - 0.55) AND PT (PSQI MD = - 0.91, 95% CI - 1.61, - 0.20) GROUPS. PARTICIPANTS WHO REPORTED A >/= 30% IMPROVEMENT IN PAIN OR PHYSICAL FUNCTION AT 6 WEEKS, COMPARED WITH THOSE WHO IMPROVED < 10%, WERE MORE LIKELY TO BE A SLEEP QUALITY RESPONDER AT 12 WEEKS (ODDS RATIO [OR] = 3.51, 95% CI 1.73, 7.11 AND OR = 2.16, 95% CI 1.18, 3.95, RESPECTIVELY). RESULTS WERE SIMILAR AT 52 WEEKS. CONCLUSION: IN A SAMPLE OF ADULTS WITH CLBP, VIRTUALLY ALL WITH POOR SLEEP QUALITY PRIOR TO INTERVENTION, MODEST BUT STATISTICALLY SIGNIFICANT IMPROVEMENTS IN SLEEP QUALITY WERE OBSERVED WITH BOTH YOGA AND PT. IRRESPECTIVE OF TREATMENT, CLINICALLY IMPORTANT SLEEP IMPROVEMENTS AT THE END OF THE INTERVENTION WERE ASSOCIATED WITH MID-INTERVENTION PAIN AND PHYSICAL FUNCTION IMPROVEMENTS. TRIAL REGISTRATION: CLINICALTRIALS.GOV IDENTIFIER: NCT01343927. 2020 14 193 49 A RANDOMIZED TRIAL COMPARING YOGA, STRETCHING, AND A SELF-CARE BOOK FOR CHRONIC LOW BACK PAIN. BACKGROUND: CHRONIC LOW BACK PAIN IS A COMMON PROBLEM LACKING HIGHLY EFFECTIVE TREATMENT OPTIONS. SMALL TRIALS SUGGEST THAT YOGA MAY HAVE BENEFITS FOR THIS CONDITION. THIS TRIAL WAS DESIGNED TO DETERMINE WHETHER YOGA IS MORE EFFECTIVE THAN CONVENTIONAL STRETCHING EXERCISES OR A SELF-CARE BOOK FOR PRIMARY CARE PATIENTS WITH CHRONIC LOW BACK PAIN. METHODS: A TOTAL OF 228 ADULTS WITH CHRONIC LOW BACK PAIN WERE RANDOMIZED TO 12 WEEKLY CLASSES OF YOGA (92 PATIENTS) OR CONVENTIONAL STRETCHING EXERCISES (91 PATIENTS) OR A SELF-CARE BOOK (45 PATIENTS). BACK-RELATED FUNCTIONAL STATUS (MODIFIED ROLAND DISABILITY QUESTIONNAIRE, A 23-POINT SCALE) AND BOTHERSOMENESS OF PAIN (AN 11-POINT NUMERICAL SCALE) AT 12 WEEKS WERE THE PRIMARY OUTCOMES. OUTCOMES WERE ASSESSED AT BASELINE, 6, 12, AND 26 WEEKS BY INTERVIEWERS UNAWARE OF TREATMENT GROUP. RESULTS: AFTER ADJUSTMENT FOR BASELINE VALUES, 12-WEEK OUTCOMES FOR THE YOGA GROUP WERE SUPERIOR TO THOSE FOR THE SELF-CARE GROUP (MEAN DIFFERENCE FOR FUNCTION, -2.5 [95% CI, -3.7 TO -1.3]; P < .001; MEAN DIFFERENCE FOR SYMPTOMS, -1.1 [95% CI, -1.7 TO -0.4]; P < .001). AT 26 WEEKS, FUNCTION FOR THE YOGA GROUP REMAINED SUPERIOR (MEAN DIFFERENCE, -1.8 [95% CI, -3.1 TO -0.5]; P < .001). YOGA WAS NOT SUPERIOR TO CONVENTIONAL STRETCHING EXERCISES AT ANY TIME POINT. CONCLUSION: YOGA CLASSES WERE MORE EFFECTIVE THAN A SELF-CARE BOOK, BUT NOT MORE EFFECTIVE THAN STRETCHING CLASSES, IN IMPROVING FUNCTION AND REDUCING SYMPTOMS DUE TO CHRONIC LOW BACK PAIN, WITH BENEFITS LASTING AT LEAST SEVERAL MONTHS. TRIAL REGISTRATION: CLINICALTRIALS.GOV IDENTIFIER: NCT00447668. 2011 15 2587 68 YOGA FOR IMPROVING HEALTH-RELATED QUALITY OF LIFE, MENTAL HEALTH AND CANCER-RELATED SYMPTOMS IN WOMEN DIAGNOSED WITH BREAST CANCER. BACKGROUND: BREAST CANCER IS THE CANCER MOST FREQUENTLY DIAGNOSED IN WOMEN WORLDWIDE. EVEN THOUGH SURVIVAL RATES ARE CONTINUALLY INCREASING, BREAST CANCER IS OFTEN ASSOCIATED WITH LONG-TERM PSYCHOLOGICAL DISTRESS, CHRONIC PAIN, FATIGUE AND IMPAIRED QUALITY OF LIFE. YOGA COMPRISES ADVICE FOR AN ETHICAL LIFESTYLE, SPIRITUAL PRACTICE, PHYSICAL ACTIVITY, BREATHING EXERCISES AND MEDITATION. IT IS A COMPLEMENTARY THERAPY THAT IS COMMONLY RECOMMENDED FOR BREAST CANCER-RELATED IMPAIRMENTS AND HAS BEEN SHOWN TO IMPROVE PHYSICAL AND MENTAL HEALTH IN PEOPLE WITH DIFFERENT CANCER TYPES. OBJECTIVES: TO ASSESS EFFECTS OF YOGA ON HEALTH-RELATED QUALITY OF LIFE, MENTAL HEALTH AND CANCER-RELATED SYMPTOMS AMONG WOMEN WITH A DIAGNOSIS OF BREAST CANCER WHO ARE RECEIVING ACTIVE TREATMENT OR HAVE COMPLETED TREATMENT. SEARCH METHODS: WE SEARCHED THE COCHRANE BREAST CANCER SPECIALISED REGISTER, MEDLINE (VIA PUBMED), EMBASE, THE COCHRANE CENTRAL REGISTER OF CONTROLLED TRIALS (CENTRAL; 2016, ISSUE 1), INDEXING OF INDIAN MEDICAL JOURNALS (INDMED), THE WORLD HEALTH ORGANIZATION (WHO) INTERNATIONAL CLINICAL TRIALS REGISTRY PLATFORM (ICTRP) SEARCH PORTAL AND CLINICALTRIALS.GOV ON 29 JANUARY 2016. WE ALSO SEARCHED REFERENCE LISTS OF IDENTIFIED RELEVANT TRIALS OR REVIEWS, AS WELL AS CONFERENCE PROCEEDINGS OF THE INTERNATIONAL CONGRESS ON COMPLEMENTARY MEDICINE RESEARCH (ICCMR), THE EUROPEAN CONGRESS FOR INTEGRATIVE MEDICINE (ECIM) AND THE AMERICAN SOCIETY OF CLINICAL ONCOLOGY (ASCO). WE APPLIED NO LANGUAGE RESTRICTIONS. SELECTION CRITERIA: RANDOMISED CONTROLLED TRIALS WERE ELIGIBLE WHEN THEY (1) COMPARED YOGA INTERVENTIONS VERSUS NO THERAPY OR VERSUS ANY OTHER ACTIVE THERAPY IN WOMEN WITH A DIAGNOSIS OF NON-METASTATIC OR METASTATIC BREAST CANCER, AND (2) ASSESSED AT LEAST ONE OF THE PRIMARY OUTCOMES ON PATIENT-REPORTED INSTRUMENTS, INCLUDING HEALTH-RELATED QUALITY OF LIFE, DEPRESSION, ANXIETY, FATIGUE OR SLEEP DISTURBANCES. DATA COLLECTION AND ANALYSIS: TWO REVIEW AUTHORS INDEPENDENTLY COLLECTED DATA ON METHODS AND RESULTS. WE EXPRESSED OUTCOMES AS STANDARDISED MEAN DIFFERENCES (SMDS) WITH 95% CONFIDENCE INTERVALS (CIS) AND CONDUCTED RANDOM-EFFECTS MODEL META-ANALYSES. WE ASSESSED POTENTIAL RISK OF PUBLICATION BIAS THROUGH VISUAL ANALYSIS OF FUNNEL PLOT SYMMETRY AND HETEROGENEITY BETWEEN STUDIES BY USING THE CHI(2) TEST AND THE I(2) STATISTIC. WE CONDUCTED SUBGROUP ANALYSES FOR CURRENT TREATMENT STATUS, TIME SINCE DIAGNOSIS, STAGE OF CANCER AND TYPE OF YOGA INTERVENTION. MAIN RESULTS: WE INCLUDED 24 STUDIES WITH A TOTAL OF 2166 PARTICIPANTS, 23 OF WHICH PROVIDED DATA FOR META-ANALYSIS. THIRTEEN STUDIES HAD LOW RISK OF SELECTION BIAS, FIVE STUDIES REPORTED ADEQUATE BLINDING OF OUTCOME ASSESSMENT AND 15 STUDIES HAD LOW RISK OF ATTRITION BIAS.SEVENTEEN STUDIES THAT COMPARED YOGA VERSUS NO THERAPY PROVIDED MODERATE-QUALITY EVIDENCE SHOWING THAT YOGA IMPROVED HEALTH-RELATED QUALITY OF LIFE (POOLED SMD 0.22, 95% CI 0.04 TO 0.40; 10 STUDIES, 675 PARTICIPANTS), REDUCED FATIGUE (POOLED SMD -0.48, 95% CI -0.75 TO -0.20; 11 STUDIES, 883 PARTICIPANTS) AND REDUCED SLEEP DISTURBANCES IN THE SHORT TERM (POOLED SMD -0.25, 95% CI -0.40 TO -0.09; SIX STUDIES, 657 PARTICIPANTS). THE FUNNEL PLOT FOR HEALTH-RELATED QUALITY OF LIFE WAS ASYMMETRICAL, FAVOURING NO THERAPY, AND THE FUNNEL PLOT FOR FATIGUE WAS ROUGHLY SYMMETRICAL. THIS HINTS AT OVERALL LOW RISK OF PUBLICATION BIAS. YOGA DID NOT APPEAR TO REDUCE DEPRESSION (POOLED SMD -0.13, 95% CI -0.31 TO 0.05; SEVEN STUDIES, 496 PARTICIPANTS; LOW-QUALITY EVIDENCE) OR ANXIETY (POOLED SMD -0.53, 95% CI -1.10 TO 0.04; SIX STUDIES, 346 PARTICIPANTS; VERY LOW-QUALITY EVIDENCE) IN THE SHORT TERM AND HAD NO MEDIUM-TERM EFFECTS ON HEALTH-RELATED QUALITY OF LIFE (POOLED SMD 0.10, 95% CI -0.23 TO 0.42; TWO STUDIES, 146 PARTICIPANTS; LOW-QUALITY EVIDENCE) OR FATIGUE (POOLED SMD -0.04, 95% CI -0.36 TO 0.29; TWO STUDIES, 146 PARTICIPANTS; LOW-QUALITY EVIDENCE). INVESTIGATORS REPORTED NO SERIOUS ADVERSE EVENTS.FOUR STUDIES THAT COMPARED YOGA VERSUS PSYCHOSOCIAL/EDUCATIONAL INTERVENTIONS PROVIDED MODERATE-QUALITY EVIDENCE INDICATING THAT YOGA CAN REDUCE DEPRESSION (POOLED SMD -2.29, 95% CI -3.97 TO -0.61; FOUR STUDIES, 226 PARTICIPANTS), ANXIETY (POOLED SMD -2.21, 95% CI -3.90 TO -0.52; THREE STUDIES, 195 PARTICIPANTS) AND FATIGUE (POOLED SMD -0.90, 95% CI -1.31 TO -0.50; TWO STUDIES, 106 PARTICIPANTS) IN THE SHORT TERM. VERY LOW-QUALITY EVIDENCE SHOWED NO SHORT-TERM EFFECTS ON HEALTH-RELATED QUALITY OF LIFE (POOLED SMD 0.81, 95% CI -0.50 TO 2.12; TWO STUDIES, 153 PARTICIPANTS) OR SLEEP DISTURBANCES (POOLED SMD -0.21, 95% CI -0.76 TO 0.34; TWO STUDIES, 119 PARTICIPANTS). NO TRIAL ADEQUATELY REPORTED SAFETY-RELATED DATA.THREE STUDIES THAT COMPARED YOGA VERSUS EXERCISE PRESENTED VERY LOW-QUALITY EVIDENCE SHOWING NO SHORT-TERM EFFECTS ON HEALTH-RELATED QUALITY OF LIFE (POOLED SMD -0.04, 95% CI -0.30 TO 0.23; THREE STUDIES, 233 PARTICIPANTS) OR FATIGUE (POOLED SMD -0.21, 95% CI -0.66 TO 0.25; THREE STUDIES, 233 PARTICIPANTS); NO TRIAL PROVIDED SAFETY-RELATED DATA. AUTHORS' CONCLUSIONS: MODERATE-QUALITY EVIDENCE SUPPORTS THE RECOMMENDATION OF YOGA AS A SUPPORTIVE INTERVENTION FOR IMPROVING HEALTH-RELATED QUALITY OF LIFE AND REDUCING FATIGUE AND SLEEP DISTURBANCES WHEN COMPARED WITH NO THERAPY, AS WELL AS FOR REDUCING DEPRESSION, ANXIETY AND FATIGUE, WHEN COMPARED WITH PSYCHOSOCIAL/EDUCATIONAL INTERVENTIONS. VERY LOW-QUALITY EVIDENCE SUGGESTS THAT YOGA MIGHT BE AS EFFECTIVE AS OTHER EXERCISE INTERVENTIONS AND MIGHT BE USED AS AN ALTERNATIVE TO OTHER EXERCISE PROGRAMMES. 2017 16 2558 52 YOGA FOR CHRONIC LOW BACK PAIN IN A PREDOMINANTLY MINORITY POPULATION: A PILOT RANDOMIZED CONTROLLED TRIAL. BACKGROUND: SEVERAL STUDIES SUGGEST YOGA MAY BE EFFECTIVE FOR CHRONIC LOW BACK PAIN; HOWEVER, TRIALS TARGETING MINORITIES HAVE NOT BEEN CONDUCTED. PRIMARY STUDY OBJECTIVES: ASSESS THE FEASIBILITY OF STUDYING YOGA IN A PREDOMINANTLY MINORITY POPULATION WITH CHRONIC LOW BACK PAIN. COLLECT PRELIMINARY DATA TO PLAN A LARGER POWERED STUDY. STUDY DESIGN: PILOT RANDOMIZED CONTROLLED TRIAL. SETTING: TWO COMMUNITY HEALTH CENTERS IN A RACIALLY DIVERSE NEIGHBORHOOD OF BOSTON, MASSACHUSETTS. PARTICIPANTS: THIRTY ENGLISH-SPEAKING ADULTS (MEAN AGE 44 YEARS, 83% FEMALE, 83% RACIAL/ETHNIC MINORITIES; 48% WITH INCOMES < OR = $30,000) WITH MODERATE-TO-SEVERE CHRONIC LOW BACK PAIN. INTERVENTIONS: STANDARDIZED SERIES OF WEEKLY HATHA YOGA CLASSES FOR 12 WEEKS COMPARED TO A WAITLIST USUAL CARE CONTROL. OUTCOME MEASURES: FEASIBILITY MEASURED BY TIME TO COMPLETE ENROLLMENT, PROPORTION OF RACIAL/ETHNIC MINORITIES ENROLLED, RETENTION RATES, AND ADVERSE EVENTS. PRIMARY EFFICACY OUTCOMES WERE CHANGES FROM BASELINE TO 12 WEEKS IN PAIN SCORE (0=NO PAIN TO 10=WORST POSSIBLE PAIN) AND BACK-RELATED FUNCTION USING THE MODIFIED ROLAND-MORRIS DISABILITY QUESTIONNAIRE (0-23 POINT SCALE, HIGHER SCORES REFLECT POORER FUNCTION). SECONDARY EFFICACY OUTCOMES WERE ANALGESIC USE, GLOBAL IMPROVEMENT, AND QUALITY OF LIFE (SF-36). RESULTS: RECRUITMENT TOOK 2 MONTHS. RETENTION RATES WERE 97% AT 12 WEEKS AND 77% AT 26 WEEKS. MEAN PAIN SCORES FOR YOGA DECREASED FROM BASELINE TO 12 WEEKS (6.7 TO 4.4) COMPARED TO USUAL CARE, WHICH DECREASED FROM 7.5 TO 7.1 (P=.02). MEAN ROLAND SCORES FOR YOGA DECREASED FROM 14.5 TO 8.2 COMPARED TO USUAL CARE, WHICH DECREASED FROM 16.1 TO 12.5 (P=.28). AT 12 WEEKS, YOGA COMPARED TO USUAL CARE PARTICIPANTS REPORTED LESS ANALGESIC USE (13% VS 73%, P=.003), LESS OPIATE USE (0% VS 33%, P=.04), AND GREATER OVERALL IMPROVEMENT (73% VS 27%, P=.03). THERE WERE NO DIFFERENCES IN SF-36 SCORES AND NO SERIOUS ADVERSE EVENTS. CONCLUSION: A YOGA STUDY INTERVENTION IN A PREDOMINANTLY MINORITY POPULATION WITH CHRONIC LOW BACK PAIN WAS MODERATELY FEASIBLE AND MAY BE MORE EFFECTIVE THAN USUAL CARE FOR REDUCING PAIN AND PAIN MEDICATION USE. 2009 17 34 41 A 12-WEEK IYENGAR YOGA PROGRAM IMPROVED BALANCE AND MOBILITY IN OLDER COMMUNITY-DWELLING PEOPLE: A PILOT RANDOMIZED CONTROLLED TRIAL. BACKGROUND: EXERCISE THAT CHALLENGES BALANCE CAN IMPROVE MOBILITY AND PREVENT FALLS IN OLDER ADULTS. YOGA AS A PHYSICAL ACTIVITY OPTION FOR OLDER ADULTS IS NOT WELL STUDIED. THIS TRIAL EVALUATED THE FEASIBILITY AND EFFECT OF A 12-WEEK IYENGAR YOGA PROGRAM ON BALANCE AND MOBILITY IN OLDER PEOPLE. METHODS: WE CONDUCTED A BLINDED, PILOT RANDOMIZED CONTROLLED TRIAL WITH INTENTION-TO-TREAT ANALYSIS. PARTICIPANTS WERE 54 COMMUNITY DWELLERS (MEAN AGE 68 YEARS, SD 7.1) NOT CURRENTLY PARTICIPATING IN YOGA OR TAI CHI. THE INTERVENTION GROUP (N = 27) PARTICIPATED IN A 12-WEEK, TWICE-WEEKLY YOGA PROGRAM FOCUSED ON STANDING POSTURES AND RECEIVED A FALL PREVENTION EDUCATION BOOKLET. THE CONTROL GROUP (N = 27) RECEIVED THE EDUCATION BOOKLET ONLY. PRIMARY OUTCOME WAS STANDING BALANCE COMPONENT OF THE SHORT PHYSICAL PERFORMANCE BATTERY WITH ADDITION OF ONE-LEGGED STANCE TIME (STANDING BALANCE). SECONDARY OUTCOMES WERE THE TIMED SIT-TO-STAND TEST, TIMED 4-M WALK, ONE-LEGGED STAND WITH EYES CLOSED, AND SHORT FALLS EFFICACY SCALE-INTERNATIONAL. FEASIBILITY WAS MEASURED BY RECORDING CLASS ATTENDANCE AND ADVERSE EVENTS. RESULTS: FIFTY-TWO PARTICIPANTS COMPLETED FOLLOW-UP ASSESSMENTS. THE INTERVENTION GROUP SIGNIFICANTLY IMPROVED COMPARED WITH CONTROL GROUP ON STANDING BALANCE (MEAN DIFFERENCE = 1.52 SECONDS, 95% CI 0.10-2.96, P = .04), SIT-TO-STAND TEST (MEAN DIFFERENCE = -3.43 SECONDS, 95% CI -5.23 TO -1.64, P < .001), 4-M WALK (MEAN DIFFERENCE = -0.50 SECONDS, 95% CI -0.72 TO -0.28, P < .001), AND ONE-LEGGED STAND WITH EYES CLOSED (MEAN DIFFERENCE = 1.93 SECONDS, 95% CI 0.40-3.46, P = .02). AVERAGE CLASS ATTENDANCE WAS 20 OF 24 CLASSES (83%). NO SERIOUS ADVERSE EVENTS OCCURRED. CONCLUSIONS: THIS TRIAL DEMONSTRATES THE BALANCE AND MOBILITY-RELATED BENEFITS AND FEASIBILITY OF IYENGAR YOGA FOR OLDER PEOPLE. THE FALL PREVENTION EFFECT OF IYENGAR YOGA WARRANTS FURTHER INVESTIGATION. 2013 18 258 46 ACCEPTABILITY AND FEASIBILITY OF A 12-WEEK YOGA VS. EDUCATIONAL FILM PROGRAM FOR THE MANAGEMENT OF RESTLESS LEGS SYNDROME (RLS): STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: RESTLESS LEGS SYNDROME (RLS) IS A COMMON AND BURDENSOME SLEEP DISORDER ASSOCIATED WITH PROFOUND IMPAIRMENT OF HEALTH, WELL-BEING, AND QUALITY OF LIFE. UNFORTUNATELY, THE MEDICATIONS USED FOR RLS MANAGEMENT CARRY RISK OF SERIOUS SIDE EFFECTS, INCLUDING AUGMENTATION OF SYMPTOMS. YOGA, AN ANCIENT MIND-BODY DISCIPLINE DESIGNED TO PROMOTE PHYSICAL, EMOTIONAL, AND MENTAL WELL-BEING, MAY OFFER A VIABLE, LOW-RISK NEW TREATMENT. THE PRIMARY OBJECTIVES OF THIS PILOT, PARALLEL-ARM, RANDOMIZED CONTROLLED TRIAL (RCT) ARE TO ASSESS THE ACCEPTABILITY AND FEASIBILITY OF A 12-WEEK YOGA VS. EDUCATIONAL FILM PROGRAM FOR THE MANAGEMENT OF RLS. METHODS: FORTY-FOUR ADULTS WITH CONFIRMED MODERATE TO SEVERE RLS WILL BE RECRUITED AND RANDOMIZED TO A 12-WEEK YOGA (N = 22) OR STANDARDIZED EDUCATIONAL FILM PROGRAM (N = 22). YOGA GROUP PARTICIPANTS WILL ATTEND TWO 75-MIN IYENGAR YOGA CLASSES PER WEEK FOR THE FIRST 4 WEEKS, THEN ONE 75-MIN CLASS PER WEEK FOR THE REMAINING 8 WEEKS, AND WILL COMPLETE A 30-MIN HOMEWORK ROUTINE ON NON-CLASS DAYS. EDUCATIONAL FILM GROUP PARTICIPANTS WILL ATTEND ONE 75-MIN CLASS PER WEEK FOR 12 WEEKS AND COMPLETE A DAILY RLS TREATMENT LOG; CLASSES WILL INCLUDE INFORMATION ON: RLS MANAGEMENT, INCLUDING SLEEP HYGIENE PRACTICES; OTHER SLEEP DISORDERS; AND COMPLEMENTARY THERAPIES LIKELY TO BE OF INTEREST TO THOSE PARTICIPATING IN A YOGA AND SLEEP EDUCATION STUDY. YOGA AND TREATMENT LOGS WILL BE COLLECTED WEEKLY. FEASIBILITY OUTCOMES WILL INCLUDE RECRUITMENT, ENROLLMENT, AND RANDOMIZATION RATES, RETENTION, ADHERENCE, AND PROGRAM SATISFACTION. PROGRAM EVALUATION AND YOGA-DOSING QUESTIONNAIRES WILL BE COLLECTED AT WEEK 12; DATA ON EXPLORATORY OUTCOMES (E.G., RLS SYMPTOM SEVERITY (IRLS), SLEEP QUALITY (PSQI), MOOD (POMS, PSS), AND HEALTH-RELATED QUALITY OF LIFE (SF-36)) WILL BE GATHERED AT BASELINE AND WEEK 12. DISCUSSION: THIS STUDY WILL LAY THE ESSENTIAL GROUNDWORK FOR A PLANNED LARGER RCT TO DETERMINE THE EFFICACY OF A YOGA PROGRAM FOR REDUCING SYMPTOMS AND ASSOCIATED BURDEN OF RLS. IF THE FINDINGS OF THE CURRENT TRIAL AND THE SUBSEQUENT LARGER RCTS ARE POSITIVE, THIS STUDY WILL ALSO HELP SUPPORT A NEW APPROACH TO CLINICAL TREATMENT OF THIS CHALLENGING DISORDER, HELP FOSTER IMPROVED UNDERSTANDING OF RLS ETIOLOGY, AND ULTIMATELY CONTRIBUTE TO REDUCING THE INDIVIDUAL, SOCIETAL, AND ECONOMIC BURDEN ASSOCIATED WITH THIS CONDITION. TRIAL REGISTRATION: CLINICALTRIALS.GOV, ID: NCT03570515 . RETROSPECTIVELY REGISTERED ON 1 FEBRUARY 2017. 2019 19 2596 58 YOGA FOR MILITARY VETERANS WITH CHRONIC LOW BACK PAIN: A RANDOMIZED CLINICAL TRIAL. INTRODUCTION: CHRONIC LOW BACK PAIN (CLBP) IS PREVALENT, ESPECIALLY AMONG MILITARY VETERANS. MANY CLBP TREATMENT OPTIONS HAVE LIMITED BENEFITS AND ARE ACCOMPANIED BY SIDE EFFECTS. MAJOR EFFORTS TO REDUCE OPIOID USE AND EMBRACE NONPHARMACOLOGICAL PAIN TREATMENTS HAVE RESULTED. RESEARCH WITH COMMUNITY CLBP PATIENTS INDICATES THAT YOGA CAN IMPROVE HEALTH OUTCOMES AND HAS FEW SIDE EFFECTS. THE BENEFITS OF YOGA AMONG MILITARY VETERANS WERE EXAMINED. DESIGN: PARTICIPANTS WERE RANDOMIZED TO EITHER YOGA OR DELAYED YOGA TREATMENT IN 2013-2015. OUTCOMES WERE ASSESSED AT BASELINE, 6 WEEKS, 12 WEEKS, AND 6 MONTHS. INTENTION-TO-TREAT ANALYSES OCCURRED IN 2016. SETTING/PARTICIPANTS: ONE HUNDRED AND FIFTY MILITARY VETERANS WITH CLBP WERE RECRUITED FROM A MAJOR VETERANS AFFAIRS MEDICAL CENTER IN CALIFORNIA. INTERVENTION: YOGA CLASSES (WITH HOME PRACTICE) WERE LED BY A CERTIFIED INSTRUCTOR TWICE WEEKLY FOR 12 WEEKS, AND CONSISTED PRIMARILY OF PHYSICAL POSTURES, MOVEMENT, AND BREATHING TECHNIQUES. MAIN OUTCOME MEASURES: THE PRIMARY OUTCOME WAS ROLAND-MORRIS DISABILITY QUESTIONNAIRE SCORES AFTER 12 WEEKS. PAIN INTENSITY WAS IDENTIFIED AS AN IMPORTANT SECONDARY OUTCOME. RESULTS: PARTICIPANT CHARACTERISTICS WERE MEAN AGE 53 YEARS, 26% WERE FEMALE, 35% WERE UNEMPLOYED OR DISABLED, AND MEAN BACK PAIN DURATION WAS 15 YEARS. IMPROVEMENTS IN ROLAND-MORRIS DISABILITY QUESTIONNAIRE SCORES DID NOT DIFFER BETWEEN THE TWO GROUPS AT 12 WEEKS, BUT YOGA PARTICIPANTS HAD GREATER REDUCTIONS IN ROLAND-MORRIS DISABILITY QUESTIONNAIRE SCORES THAN DELAYED TREATMENT PARTICIPANTS AT 6 MONTHS -2.48 (95% CI= -4.08, -0.87). YOGA PARTICIPANTS IMPROVED MORE ON PAIN INTENSITY AT 12 WEEKS AND AT 6 MONTHS. OPIOID MEDICATION USE DECLINED AMONG ALL PARTICIPANTS, BUT GROUP DIFFERENCES WERE NOT FOUND. CONCLUSIONS: YOGA IMPROVED HEALTH OUTCOMES AMONG VETERANS DESPITE EVIDENCE THEY HAD FEWER RESOURCES, WORSE HEALTH, AND MORE CHALLENGES ATTENDING YOGA SESSIONS THAN COMMUNITY SAMPLES STUDIED PREVIOUSLY. THE MAGNITUDE OF PAIN INTENSITY DECLINE WAS SMALL, BUT OCCURRED IN THE CONTEXT OF REDUCED OPIOID USE. THE FINDINGS SUPPORT WIDER IMPLEMENTATION OF YOGA PROGRAMS FOR VETERANS. TRIAL REGISTRATION: THIS STUDY IS REGISTERED AT WWW.CLINICALTRIALS.GOV NCT02524158. 2017 20 2552 48 YOGA FOR CHEMOTHERAPY-INDUCED PERIPHERAL NEUROPATHY AND FALL RISK: A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: CHEMOTHERAPY-INDUCED PERIPHERAL NEUROPATHY (CIPN) IS A COMMON, DEBILITATING SIDE EFFECT THAT WORSENS QUALITY OF LIFE AND INCREASES THE RISK OF FALLS IN CANCER SURVIVORS. EVIDENCE OF YOGA'S SAFETY AND EFFICACY IN TREATING CIPN IS LACKING. METHODS: IN A RANDOMIZED CONTROLLED STUDY, WE ASSIGNED BREAST AND GYNECOLOGICAL CANCER SURVIVORS WITH PERSISTENT MODERATE-TO-SEVERE CIPN PAIN, NUMBNESS, OR TINGLING WITH A SCORE OF 4 OR GREATER (0-10 NUMERIC RATING SCALE [NRS]) FOR AT LEAST 3 MONTHS AFTER CHEMOTHERAPY TO 8 WEEKS OF USUAL CARE OR YOGA FOCUSED ON BREATHWORK AND MUSCULOSKELETAL CONDITIONING. PRIMARY ENDPOINT WAS TREATMENT ARM DIFFERENCES FOR NRS, AND SECONDARY ENDPOINTS WERE FUNCTIONAL ASSESSMENT OF CANCER THERAPY/GYNECOLOGIC ONCOLOGY GROUP-NEUROTOXICITY SUBSCALE (FACT/GOG-NTX), AND FUNCTIONAL REACH TEST AFTER WEEK 8. WE TESTED TREATMENT ARM DIFFERENCES FOR EACH OUTCOME MEASURE USING LINEAR MIXED MODELS WITH TREATMENT-BY-TIME INTERACTIONS. ALL STATISTICAL TESTS WERE TWO-SIDED. RESULTS: WE RANDOMLY ASSIGNED 41 PARTICIPANTS INTO YOGA (N = 21) OR USUAL CARE (N = 20). AT WEEK 8, MEAN NRS PAIN DECREASED BY 1.95 POINTS (95% CONFIDENCE INTERVAL [CI] = -3.20 TO -0.70) IN YOGA VS 0.65 (95% CI = -1.81 TO 0.51) IN USUAL CARE (P = .14). FACT/GOG-NTX IMPROVED BY 4.25 (95% CI = 2.29 TO 6.20) IN YOGA VS 1.36 (95% CI = -0.47 TO 3.19) IN USUAL CARE (P = .035). FUNCTIONAL REACH, AN OBJECTIVE FUNCTIONAL MEASURE PREDICTING THE RISK OF FALLS, IMPROVED BY 7.14 CM (95% CI = 3.68 TO 10.59) IN YOGA AND DECREASED BY 1.65 CM (95% CI = -5.00 TO 1.72) IN USUAL CARE (P = .001). FOUR GRADE 1 ADVERSE EVENTS WERE OBSERVED IN THE YOGA ARM. CONCLUSION: AMONG BREAST AND GYNECOLOGICAL CANCER SURVIVORS WITH MODERATE-TO-SEVERE CIPN, YOGA WAS SAFE AND SHOWED PROMISING EFFICACY IN IMPROVING CIPN SYMPTOMS. 2020