1 2596 182 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 2 2831 51 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 3 2638 71 YOGA FOR VETERANS WITH CHRONIC LOW BACK PAIN: DESIGN AND METHODS OF A RANDOMIZED CLINICAL TRIAL. CHRONIC LOW BACK PAIN (CLBP) AFFLICTS MILLIONS OF PEOPLE WORLDWIDE, WITH PARTICULARLY HIGH PREVALENCE IN MILITARY VETERANS. MANY TREATMENT OPTIONS EXIST FOR CLBP, BUT MOST HAVE LIMITED EFFECTIVENESS AND SOME HAVE SIGNIFICANT SIDE EFFECTS. IN GENERAL POPULATIONS WITH CLBP, YOGA HAS BEEN SHOWN TO IMPROVE HEALTH OUTCOMES WITH FEW SIDE EFFECTS. HOWEVER, YOGA HAS NOT BEEN ADEQUATELY STUDIED IN MILITARY VETERAN POPULATIONS. IN THE CURRENT PAPER WE WILL DESCRIBE THE DESIGN AND METHODS OF A RANDOMIZED CLINICAL TRIAL AIMED AT EXAMINING WHETHER YOGA CAN EFFECTIVELY REDUCE DISABILITY AND PAIN IN US MILITARY VETERANS WITH CLBP. A TOTAL OF 144 US MILITARY VETERANS WITH CLBP WILL BE RANDOMIZED TO EITHER YOGA OR A DELAYED TREATMENT COMPARISON GROUP. THE YOGA INTERVENTION WILL CONSIST OF 2X WEEKLY YOGA CLASSES FOR 12WEEKS, COMPLEMENTED BY REGULAR HOME PRACTICE GUIDED BY A MANUAL. THE DELAYED TREATMENT GROUP WILL RECEIVE THE SAME INTERVENTION AFTER SIX MONTHS. THE PRIMARY OUTCOME IS THE CHANGE IN BACK PAIN-RELATED DISABILITY MEASURED WITH THE ROLAND-MORRIS DISABILITY QUESTIONNAIRE AT BASELINE AND 12-WEEKS. SECONDARY OUTCOMES INCLUDE PAIN INTENSITY, PAIN INTERFERENCE, DEPRESSION, ANXIETY, FATIGUE/ENERGY, QUALITY OF LIFE, SELF-EFFICACY, SLEEP QUALITY, AND MEDICATION USAGE. ADDITIONAL PROCESS AND/OR MEDIATIONAL FACTORS WILL BE MEASURED TO EXAMINE DOSE RESPONSE AND EFFECT MECHANISMS. ASSESSMENTS WILL BE CONDUCTED AT BASELINE, 6-WEEKS, 12-WEEKS, AND 6-MONTHS. ALL RANDOMIZED PARTICIPANTS WILL BE INCLUDED IN INTENTION-TO-TREAT ANALYSES. STUDY RESULTS WILL PROVIDE MUCH NEEDED EVIDENCE ON THE FEASIBILITY AND EFFECTIVENESS OF YOGA AS A THERAPEUTIC MODALITY FOR THE TREATMENT OF CLBP IN US MILITARY VETERANS. 2016 4 521 62 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 5 2441 44 YOGA AND SCHIZOPHRENIA-A COMPREHENSIVE ASSESSMENT OF NEUROPLASTICITY: PROTOCOL FOR A SINGLE BLIND RANDOMIZED CONTROLLED STUDY OF YOGA IN SCHIZOPHRENIA. INTRODUCTION: SCHIZOPHRENIA IS ONE OF THE MOST SEVERE MENTAL DISORDERS WITH A PREVALENCE OF ABOUT 1% AND A LEADING CAUSE OF DISABILITY AMONG YOUNG ADULTS. PHARMACOTHERAPY IS THE MAINSTAY IN THE MANAGEMENT OF SCHIZOPHRENIA. HOWEVER, EVEN WITH THE BEST OF MEDICATION, SEVERAL PROBLEMS LIKE REFRACTORINESS, NEGATIVE SYMPTOMS, FREQUENT RELAPSES, AND COGNITIVE IMPAIRMENTS PERSIST. METHODS: THIS IS A RANDOMIZED-CONTROLLED CLINICAL STUDY INCLUDING PATIENTS FROM AN URBAN TERTIARY HOSPITAL AND A SEMI-URBAN COMMUNITY CENTER, WITH A BETWEEN-GROUP, REPEATED-MEASURES, LONGITUDINAL DESIGN. THIS STUDY WILL RECRUIT 160 PATIENTS WITH DSM 5 DIAGNOSIS OF SCHIZOPHRENIA WHO ARE ON STABLE MEDICATION FOR A MINIMUM OF 6 WEEKS; THEY WILL BE RANDOMLY ASSIGNED INTO 2 ARMS VIZ., YOGA THERAPY (YT), AND TREATMENT-AS-USUAL (TAU) WITH 80 PATIENTS IN EACH ARM. PARTICIPANTS WILL UNDERGO CLINICAL, LABORATORY, AND RADIOLOGICAL ASSESSMENTS AT BASELINE AND AT INTERVALS OF 1 MONTH, 3 MONTHS, AND 6 MONTHS FROM THE BASELINE. IT IS HYPOTHESIZED THAT YOGA WILL IMPROVE PSYCHOPATHOLOGY AND EMOTION PROCESSING, INCREASE SERUM BRAIN DERIVED NEUROTROPHIC FACTOR (BDNF) AND PLASMA OXYTOCIN LEVELS AND EFFECT CHANGES IN CEREBRAL ACTIVATION IN AREAS OF THE BRAIN ASSOCIATED WITH SCHIZOPHRENIA. DISCUSSION: THIS STUDY AIMS TO MEASURE THE EFFICACY OF A YOGA-BASED INTERVENTION AS AN ADJUNCT IN PATIENTS WITH SCHIZOPHRENIA AS WELL AS THE MECHANISMS OF THESE EFFECTS. TRIAL REGISTRATION: REGISTERED RETROSPECTIVELY WITH CLINICAL TRIAL REGISTRY - INDIA (CTRI) WITH REGISTRATION NUMBER CTRI/2017/08/009219. 2019 6 2782 38 YOGA THERAPY AS AN ADD-ON TREATMENT IN THE MANAGEMENT OF PATIENTS WITH SCHIZOPHRENIA--A RANDOMIZED CONTROLLED TRIAL. OBJECTIVE: TREATMENT OF SCHIZOPHRENIA HAS REMAINED UNSATISFACTORY DESPITE THE AVAILABILITY OF ANTIPSYCHOTICS. THIS STUDY EXAMINED THE EFFICACY OF YOGA THERAPY (YT) AS AN ADD-ON TREATMENT TO THE ONGOING ANTIPSYCHOTIC TREATMENT. METHOD: SIXTY-ONE MODERATELY ILL SCHIZOPHRENIA PATIENTS WERE RANDOMLY ASSIGNED TO YT (N = 31) AND PHYSICAL EXERCISE THERAPY (PT; N = 30) FOR 4 MONTHS. THEY WERE ASSESSED AT BASELINE AND 4 MONTHS AFTER THE START OF INTERVENTION, BY A RATER WHO WAS BLIND TO THEIR GROUP STATUS. RESULTS: FORTY-ONE SUBJECTS (YT = 21; PT = 20) WERE AVAILABLE AT THE END OF 4 MONTHS FOR ASSESSMENT. SUBJECTS IN THE YT GROUP HAD SIGNIFICANTLY LESS PSYCHOPATHOLOGY THAN THOSE IN THE PT GROUP AT THE END OF 4 MONTHS. THEY ALSO HAD SIGNIFICANTLY GREATER SOCIAL AND OCCUPATIONAL FUNCTIONING AND QUALITY OF LIFE. CONCLUSION: BOTH NON-PHARMACOLOGICAL INTERVENTIONS CONTRIBUTE TO REDUCTION IN SYMPTOMS, WITH YT HAVING BETTER EFFICACY. 2007 7 2824 53 YOGA VERSUS EDUCATION FOR VETERANS WITH CHRONIC LOW BACK PAIN: STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: CHRONIC LOW BACK PAIN IS THE MOST FREQUENT PAIN CONDITION IN VETERANS AND CAUSES SUBSTANTIAL SUFFERING, DECREASED FUNCTIONAL CAPACITY, AND LOWER QUALITY OF LIFE. SYMPTOMS OF POST-TRAUMATIC STRESS, DEPRESSION, AND MILD TRAUMATIC BRAIN INJURY ARE HIGHLY PREVALENT IN VETERANS WITH BACK PAIN. YOGA FOR LOW BACK PAIN HAS BEEN DEMONSTRATED TO BE EFFECTIVE FOR CIVILIANS IN RANDOMIZED CONTROLLED TRIALS. HOWEVER, IT IS UNKNOWN IF RESULTS FROM PREVIOUSLY PUBLISHED TRIALS GENERALIZE TO MILITARY POPULATIONS. METHODS/DESIGN: THIS STUDY IS A PARALLEL RANDOMIZED CONTROLLED TRIAL COMPARING YOGA TO EDUCATION FOR 120 VETERANS WITH CHRONIC LOW BACK PAIN. PARTICIPANTS ARE VETERANS >/=18 YEARS OLD WITH LOW BACK PAIN PRESENT ON AT LEAST HALF THE DAYS IN THE PAST SIX MONTHS AND A SELF-REPORTED AVERAGE PAIN INTENSITY IN THE PREVIOUS WEEK OF >/=4 ON A 0-10 SCALE. THE 24-WEEK STUDY HAS AN INITIAL 12-WEEK INTERVENTION PERIOD, WHERE PARTICIPANTS ARE RANDOMIZED EQUALLY INTO (1) A STANDARDIZED WEEKLY GROUP YOGA CLASS WITH HOME PRACTICE OR (2) EDUCATION DELIVERED WITH A SELF-CARE BOOK. PRIMARY OUTCOME MEASURES ARE CHANGE AT 12 WEEKS IN LOW BACK PAIN INTENSITY MEASURED BY THE DEFENSE AND VETERANS PAIN RATING SCALE (0-10) AND BACK-RELATED FUNCTION USING THE 23-POINT ROLAND MORRIS DISABILITY QUESTIONNAIRE. IN THE SUBSEQUENT 12-WEEK FOLLOW-UP PERIOD, YOGA PARTICIPANTS ARE ENCOURAGED TO CONTINUE HOME YOGA PRACTICE AND EDUCATION PARTICIPANTS CONTINUE FOLLOWING RECOMMENDATIONS FROM THE BOOK. QUALITATIVE INTERVIEWS WITH VETERANS IN THE YOGA GROUP AND THEIR PARTNERS EXPLORE THE IMPACT OF CHRONIC LOW BACK PAIN AND YOGA ON FAMILY RELATIONSHIPS. WE ALSO ASSESS COST-EFFECTIVENESS FROM THREE PERSPECTIVES: THE VETERAN, THE VETERANS HEALTH ADMINISTRATION, AND SOCIETY USING ELECTRONIC MEDICAL RECORDS, SELF-REPORTED COST DATA, AND STUDY RECORDS. DISCUSSION: THIS STUDY WILL HELP DETERMINE IF YOGA CAN BECOME AN EFFECTIVE TREATMENT FOR VETERANS WITH CHRONIC LOW BACK PAIN AND PSYCHOLOGICAL COMORBIDITIES. TRIAL REGISTRATION: CLINICALTRIALS.GOV: NCT02224183. 2016 8 2852 66 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 9 1180 60 EVALUATION OF THE EFFECTIVENESS AND EFFICACY OF IYENGAR YOGA THERAPY ON CHRONIC LOW BACK PAIN. STUDY DESIGN: THE EFFECTIVENESS AND EFFICACY OF IYENGAR YOGA FOR CHRONIC LOW BACK PAIN (CLBP) WERE ASSESSED WITH INTENTION-TO-TREAT AND PER-PROTOCOL ANALYSIS. NINETY SUBJECTS WERE RANDOMIZED TO A YOGA (N = 43) OR CONTROL GROUP (N = 47) RECEIVING STANDARD MEDICAL CARE. PARTICIPANTS WERE FOLLOWED 6 MONTHS AFTER COMPLETION OF THE INTERVENTION. OBJECTIVE: THIS STUDY AIMED TO EVALUATE IYENGAR YOGA THERAPY ON CHRONIC LOW BACK PAIN. YOGA SUBJECTS WERE HYPOTHESIZED TO REPORT GREATER REDUCTIONS IN FUNCTIONAL DISABILITY, PAIN INTENSITY, DEPRESSION, AND PAIN MEDICATION USAGE THAN CONTROLS. SUMMARY OF BACKGROUND DATA: CLBP IS A MUSCULOSKELETAL DISORDER WITH PUBLIC HEALTH AND ECONOMIC IMPACT. PILOT STUDIES OF YOGA AND BACK PAIN HAVE REPORTED SIGNIFICANT CHANGES IN CLINICALLY IMPORTANT OUTCOMES. METHODS: SUBJECTS WERE RECRUITED THROUGH SELF-REFERRAL AND HEALTH PROFESSIONAL REFERRALS ACCORDING TO EXPLICIT INCLUSION/EXCLUSION CRITERIA. YOGA SUBJECTS PARTICIPATED IN 24 WEEKS OF BIWEEKLY YOGA CLASSES DESIGNED FOR CLBP. OUTCOMES WERE ASSESSED AT 12 (MIDWAY), 24 (IMMEDIATELY AFTER), AND 48 WEEKS (6-MONTH FOLLOW-UP) AFTER THE START OF THE INTERVENTION USING THE OSWESTRY DISABILITY QUESTIONNAIRE, A VISUAL ANALOG SCALE, THE BECK DEPRESSION INVENTORY, AND A PAIN MEDICATION-USAGE QUESTIONNAIRE. RESULTS: USING INTENTION-TO-TREAT ANALYSIS WITH REPEATED MEASURES ANOVA (GROUP X TIME), SIGNIFICANTLY GREATER REDUCTIONS IN FUNCTIONAL DISABILITY AND PAIN INTENSITY WERE OBSERVED IN THE YOGA GROUP WHEN COMPARED TO THE CONTROL GROUP AT 24 WEEKS. A SIGNIFICANTLY GREATER PROPORTION OF YOGA SUBJECTS ALSO REPORTED CLINICAL IMPROVEMENTS AT BOTH 12 AND 24 WEEKS. IN ADDITION, DEPRESSION WAS SIGNIFICANTLY LOWER IN YOGA SUBJECTS. FURTHERMORE, WHILE A REDUCTION IN PAIN MEDICATION OCCURRED, THIS WAS COMPARABLE IN BOTH GROUPS. WHEN RESULTS WERE ANALYZED USING PER-PROTOCOL ANALYSIS, IMPROVEMENTS WERE OBSERVED FOR ALL OUTCOMES IN THE YOGA GROUP, INCLUDING AGREATER TREND FOR REDUCED PAIN MEDICATION USAGE. ALTHOUGH SLIGHTLY LESS THAN AT 24 WEEKS, THE YOGA GROUP HAD STATISTICALLY SIGNIFICANT REDUCTIONS IN FUNCTIONAL DISABILITY, PAIN INTENSITY, AND DEPRESSION COMPARED TO STANDARD MEDICAL CARE 6-MONTHS POSTINTERVENTION. CONCLUSION: YOGA IMPROVES FUNCTIONAL DISABILITY, PAIN INTENSITY, AND DEPRESSION IN ADULTS WITH CLBP. THERE WAS ALSO A CLINICALLY IMPORTANT TREND FOR THE YOGA GROUP TO REDUCE THEIR PAIN MEDICATION USAGE COMPARED TO THE CONTROL GROUP. 2009 10 193 59 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 11 1699 63 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 12 1953 97 SECONDARY OUTCOMES FROM A RANDOMIZED CONTROLLED TRIAL OF YOGA FOR VETERANS WITH CHRONIC LOW-BACK PAIN. CHRONIC LOW-BACK PAIN (CLBP) IS A PREVALENT CONDITION, AND RATES ARE HIGHER AMONG MILITARY VETERANS. CLBP IS A PERSISTENT CONDITION, AND TREATMENT OPTIONS HAVE EITHER MODEST EFFECTS OR A SIGNIFICANT RISK OF SIDE-EFFECTS, WHICH HAS LED TO RECENT EFFORTS TO EXPLORE MIND-BODY INTERVENTION OPTIONS AND REDUCE OPIOID MEDICATION USE. PRIOR STUDIES OF YOGA FOR CLBP IN COMMUNITY SAMPLES, AND THE MAIN RESULTS OF A RECENT TRIAL WITH MILITARY VETERANS, INDICATE THAT YOGA CAN REDUCE BACK-RELATED DISABILITY AND PAIN INTENSITY. SECONDARY OUTCOMES FROM THE TRIAL OF YOGA WITH MILITARY VETERANS ARE PRESENTED HERE. IN THE STUDY, 150 MILITARY VETERANS (VETERANS ADMINISTRATION PATIENTS) WITH CLBP WERE RANDOMIZED TO EITHER YOGA OR A DELAYED-TREATMENT GROUP RECEIVING USUAL CARE BETWEEN 2013 AND 2015. ASSESSMENTS OCCURRED AT BASELINE, 6 WEEKS, 12 WEEKS, AND 6 MONTHS. INTENT-TO-TREAT ANALYSES WERE CONDUCTED. YOGA CLASSES LASTING 60 MINUTES EACH WERE OFFERED TWICE WEEKLY FOR 12 WEEKS. YOGA SESSIONS CONSISTED OF PHYSICAL POSTURES, MOVEMENT, FOCUSED ATTENTION, AND BREATHING TECHNIQUES. HOME PRACTICE GUIDED BY A MANUAL WAS STRONGLY RECOMMENDED. THE PRIMARY OUTCOME MEASURE WAS ROLAND-MORRIS DISABILITY QUESTIONNAIRE SCORES AFTER 12 WEEKS. SECONDARY OUTCOMES INCLUDED PAIN INTENSITY, PAIN INTERFERENCE, DEPRESSION, FATIGUE, QUALITY OF LIFE, SELF-EFFICACY, AND MEDICATION USAGE. YOGA PARTICIPANTS IMPROVED MORE THAN DELAYED-TREATMENT PARTICIPANTS ON PAIN INTERFERENCE, FATIGUE, QUALITY OF LIFE, AND SELF-EFFICACY AT 12 WEEKS AND/OR 6 MONTHS. YOGA PARTICIPANTS HAD GREATER IMPROVEMENTS ACROSS A NUMBER OF IMPORTANT SECONDARY HEALTH OUTCOMES COMPARED TO CONTROLS. BENEFITS EMERGED DESPITE SOME VETERANS FACING CHALLENGES WITH ATTENDING YOGA SESSIONS IN PERSON. THE FINDINGS SUPPORT WIDER IMPLEMENTATION OF YOGA PROGRAMS FOR VETERANS, WITH ATTENTION TO INCREASING ACCESSIBILITY OF YOGA PROGRAMS IN THIS POPULATION. 2020 13 933 39 EFFECTIVENESS OF YOGA THERAPY IN THE TREATMENT OF MIGRAINE WITHOUT AURA: A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: NUMEROUS STUDIES HAVE EXPLORED THE EFFECTIVENESS OF COMPLEMENTARY AND ALTERNATIVE MEDICINE IN THE TREATMENT OF MIGRAINE BUT THERE IS NO DOCUMENTED INVESTIGATION OF THE EFFECTIVENESS OF YOGA THERAPY FOR MIGRAINE MANAGEMENT. OBJECTIVES: TO INVESTIGATE THE EFFECTIVENESS OF HOLISTIC APPROACH OF YOGA THERAPY FOR MIGRAINE TREATMENT COMPARED TO SELF-CARE. DESIGN: A RANDOMIZED CONTROLLED TRIAL. METHODS: SEVENTY-TWO PATIENTS WITH MIGRAINE WITHOUT AURA WERE RANDOMLY ASSIGNED TO YOGA THERAPY OR SELF-CARE GROUP FOR 3 MONTHS. PRIMARY OUTCOMES WERE HEADACHE FREQUENCY (HEADACHE DIARY), SEVERITY OF MIGRAINE (0-10 NUMERICAL SCALE) AND PAIN COMPONENT (MCGILL PAIN QUESTIONNAIRE). SECONDARY OUTCOMES WERE ANXIETY AND DEPRESSION (HOSPITAL ANXIETY DEPRESSION SCALE), MEDICATION SCORE. RESULTS: AFTER ADJUSTMENT FOR BASELINE VALUES, THE SUBJECTS' COMPLAINTS RELATED TO HEADACHE INTENSITY (P < .001), FREQUENCY (P < .001), PAIN RATING INDEX (P < .001), AFFECTIVE PAIN RATING INDEX (P < .001), TOTAL PAIN RATING INDEX (P < .001), ANXIETY AND DEPRESSION SCORES (P < .001), SYMPTOMATIC MEDICATION USE (P < .001) WERE SIGNIFICANTLY LOWER IN THE YOGA GROUP COMPARED TO THE SELF-CARE GROUP. CONCLUSION: THE STUDY DEMONSTRATED A SIGNIFICANT REDUCTION IN MIGRAINE HEADACHE FREQUENCY AND ASSOCIATED CLINICAL FEATURES, IN PATIENTS TREATED WITH YOGA OVER A PERIOD OF 3 MONTHS. FURTHER STUDY OF THIS THERAPEUTIC INTERVENTION APPEARS TO BE WARRANTED. 2007 14 232 45 A SYSTEMATIC REVIEW OF YOGA FOR MAJOR DEPRESSIVE DISORDER. BACKGROUND: THE PURPOSE OF THIS REVIEW WAS TO INVESTIGATE THE EFFICACY AND SAFETY OF YOGA INTERVENTIONS IN TREATING PATIENTS WITH MAJOR DEPRESSIVE DISORDER. METHODS: MEDLINE, SCOPUS, AND THE COCHRANE LIBRARY WERE SCREENED THROUGH DECEMBER 2016. RANDOMIZED CONTROLLED TRIALS (RCTS) COMPARING YOGA TO INACTIVE OR ACTIVE COMPARATORS IN PATIENTS WITH MAJOR DEPRESSIVE DISORDER WERE ELIGIBLE. PRIMARY OUTCOMES INCLUDED REMISSION RATES AND SEVERITY OF DEPRESSION. ANXIETY AND ADVERSE EVENTS WERE SECONDARY OUTCOMES. RISK OF BIAS WAS ASSESSED USING THE COCHRANE TOOL. RESULTS: SEVEN RCTS WITH 240 PARTICIPANTS WERE INCLUDED. RISK OF BIAS WAS UNCLEAR FOR MOST RCTS. COMPARED TO AEROBIC EXERCISE, NO SHORT- OR MEDIUM-TERM GROUP DIFFERENCES IN DEPRESSION SEVERITY WAS FOUND. HIGHER SHORT-TERM DEPRESSION SEVERITY WAS FOUND FOR YOGA COMPARED TO ELECTRO-CONVULSIVE THERAPY; REMISSION RATES DID NOT DIFFER BETWEEN GROUPS. NO SHORT-TERM GROUP DIFFERENCES OCCURRED WHEN YOGA WAS COMPARED TO ANTIDEPRESSANT MEDICATION. CONFLICTING EVIDENCE WAS FOUND WHEN YOGA WAS COMPARED TO ATTENTION-CONTROL INTERVENTIONS, OR WHEN YOGA AS AN ADD-ON TO ANTIDEPRESSANT MEDICATION WAS COMPARED TO MEDICATION ALONE. ONLY TWO RCTS ASSESSED ADVERSE EVENTS AND REPORTED THAT NO TREATMENT-RELATED ADVERSE EVENTS WERE REPORTED. LIMITATIONS: FEW RCTS WITH LOW SAMPLE SIZE. CONCLUSIONS: THIS REVIEW FOUND SOME EVIDENCE FOR POSITIVE EFFECTS BEYOND PLACEBO AND COMPARABLE EFFECTS COMPARED TO EVIDENCE-BASED INTERVENTIONS. HOWEVER, METHODOLOGICAL PROBLEMS AND THE UNCLEAR RISK-BENEFIT RATIO PRECLUDE DEFINITIVE RECOMMENDATIONS FOR OR AGAINST YOGA AS AN ADJUNCT TREATMENT FOR MAJOR DEPRESSIVE DISORDER. LARGER AND ADEQUATELY POWERED RCTS USING NON-INFERIORITY DESIGNS ARE NEEDED. 2017 15 162 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 16 721 56 EFFECT OF IYENGAR YOGA THERAPY FOR CHRONIC LOW BACK PAIN. LOW BACK PAIN IS A SIGNIFICANT PUBLIC HEALTH PROBLEM AND ONE OF THE MOST COMMONLY REPORTED REASONS FOR THE USE OF COMPLEMENTARY ALTERNATIVE MEDICINE. A RANDOMIZED CONTROL TRIAL WAS CONDUCTED IN SUBJECTS WITH NON-SPECIFIC CHRONIC LOW BACK PAIN COMPARING IYENGAR YOGA THERAPY TO AN EDUCATIONAL CONTROL GROUP. BOTH PROGRAMS WERE 16 WEEKS LONG. SUBJECTS WERE PRIMARILY SELF-REFERRED AND SCREENED BY PRIMARY CARE PHYSICIANS FOR STUDY OF INCLUSION/EXCLUSION CRITERIA. THE PRIMARY OUTCOME FOR THE STUDY WAS FUNCTIONAL DISABILITY. SECONDARY OUTCOMES INCLUDING PRESENT PAIN INTENSITY, PAIN MEDICATION USAGE, PAIN-RELATED ATTITUDES AND BEHAVIORS, AND SPINAL RANGE OF MOTION WERE MEASURED BEFORE AND AFTER THE INTERVENTIONS. SUBJECTS HAD LOW BACK PAIN FOR 11.2+/-1.54 YEARS AND 48% USED PAIN MEDICATION. OVERALL, SUBJECTS PRESENTED WITH LESS PAIN AND LOWER FUNCTIONAL DISABILITY THAN SUBJECTS IN OTHER PUBLISHED INTERVENTION STUDIES FOR CHRONIC LOW BACK PAIN. OF THE 60 SUBJECTS ENROLLED, 42 (70%) COMPLETED THE STUDY. MULTIVARIATE ANALYSES OF OUTCOMES IN THE CATEGORIES OF MEDICAL, FUNCTIONAL, PSYCHOLOGICAL AND BEHAVIORAL FACTORS INDICATED THAT SIGNIFICANT DIFFERENCES BETWEEN GROUPS EXISTED IN FUNCTIONAL AND MEDICAL OUTCOMES BUT NOT FOR THE PSYCHOLOGICAL OR BEHAVIORAL OUTCOMES. UNIVARIATE ANALYSES OF MEDICAL AND FUNCTIONAL OUTCOMES REVEALED SIGNIFICANT REDUCTIONS IN PAIN INTENSITY (64%), FUNCTIONAL DISABILITY (77%) AND PAIN MEDICATION USAGE (88%) IN THE YOGA GROUP AT THE POST AND 3-MONTH FOLLOW-UP ASSESSMENTS. THESE PRELIMINARY DATA INDICATE THAT THE MAJORITY OF SELF-REFERRED PERSONS WITH MILD CHRONIC LOW BACK PAIN WILL COMPLY TO AND REPORT IMPROVEMENT ON MEDICAL AND FUNCTIONAL PAIN-RELATED OUTCOMES FROM IYENGAR YOGA THERAPY. 2005 17 1787 54 PREFERENCE AND EXPECTATION FOR TREATMENT ASSIGNMENT IN A RANDOMIZED CONTROLLED TRIAL OF ONCE- VS TWICE-WEEKLY YOGA FOR CHRONIC LOW BACK PAIN. BACKGROUND: IN STUDIES INVOLVING NONPHARMACOLOGICAL COMPLEMENTARY AND ALTERNATIVE MEDICINE INTERVENTIONS, PARTICIPANT BLINDING IS VERY DIFFICULT. PARTICIPANT EXPECTATIONS MAY AFFECT PERCEIVED BENEFIT OF THERAPY. IN STUDIES OF YOGA AS TREATMENT FOR CHRONIC LOW BACK PAIN, LITTLE IS KNOWN ABOUT THE RELATIONSHIP BETWEEN PATIENT EXPECTATIONS AND PREFERENCES ON OUTCOMES. THIS STUDY WAS DESIGNED TO IDENTIFY BASELINE PREDICTORS OF PREFERENCE AND TO DETERMINE IF EXPECTATIONS AND PREFERENCES FOR DIFFERENT DOSES OF YOGA AFFECT BACK-RELATED FUNCTION AND LOW BACK PAIN INTENSITY. METHODS: THIS WAS A SECONDARY DATA ANALYSIS OF A 12-WEEK RANDOMIZED CONTROLLED TRIAL COMPARING ONCE-WEEKLY VS TWICE-WEEKLY YOGA FOR TREATMENT OF CHRONIC LOW BACK PAIN IN 93 ADULTS FROM A PREDOMINANTLY LOW-INCOME MINORITY POPULATION. AT BASELINE, PARTICIPANTS WERE ASKED ABOUT BACK FUNCTION, BACK PAIN, TREATMENT EXPECTATIONS, AND TREATMENT PREFERENCES. WE CREATED A VARIABLE "CONCORDANCE" TO DESCRIBE THE MATCHING OF PARTICIPANT PREFERENCE TO RANDOMIZED TREATMENT. OUR OUTCOME VARIABLES WERE CHANGE IN BACK FUNCTION AND PAIN INTENSITY AFTER 12 WEEKS OF YOGA INSTRUCTION. WE PERFORMED LOGISTIC REGRESSION TO IDENTIFY PREDICTORS OF PREFERENCE FOR ONCE- OR TWICE-WEEKLY YOGA INSTRUCTION. WE CREATED LINEAR REGRESSION MODELS TO IDENTIFY INDEPENDENT ASSOCIATIONS BETWEEN EXPECTATIONS, PREFERENCE, CONCORDANCE, AND OUTCOMES. RESULTS: WORSE BACK FUNCTION AT BASELINE WAS ASSOCIATED WITH 20% HIGHER ODDS OF PREFERRING TWICE-WEEKLY YOGA (OR 1.2, CI 1.1, 1.3). INDIVIDUALS WITH HIGHER EXPECTATION SCORES FOR TWICE-WEEKLY YOGA HAD 90% HIGHER ODDS OF PREFERRING TWICE-WEEKLY VS ONCE-WEEKLY YOGA (OR 1.9, CI 1.3, 2.7). INDIVIDUALS WITH HIGHER EXPECTATION SCORES FOR ONCE-WEEKLY YOGA HAD 40% LESS ODDS OF PREFERRING TWICE-WEEKLY YOGA (OR 0.6, CI 0.5, 0.9). AFTER CONTROLLING FOR BASELINE CHARACTERISTICS, WE FOUND NO STATISTICALLY SIGNIFICANT RELATIONSHIP BETWEEN TREATMENT OUTCOMES, PREFERENCE, EXPECTATION SCORES, OR CONCORDANCE. CONCLUSION: IN A POPULATION OF PREDOMINANTLY LOW-INCOME MINORITY PARTICIPANTS WITH CHRONIC LOW BACK PAIN, WORSE BACK FUNCTION WAS ASSOCIATED WITH PREFERENCE FOR MORE FREQUENT YOGA CLASSES. THOSE WHO PREFERRED MORE YOGA CLASSES HAD HIGHER EXPECTATIONS FOR THOSE CLASSES. TWELVE-WEEK CHANGE IN BACK PAIN INTENSITY AND BACK FUNCTION WERE NOT AFFECTED BY DOSING PREFERENCE, EXPECTATION SCORE, OR CONCORDANCE. MORE RESEARCH IS NEEDED TO BETTER MEASURE AND QUANTIFY PREFERENCE, EXPECTATIONS, AND THEIR RELATIONSHIP TO OUTCOMES IN YOGA RESEARCH. 2015 18 1370 51 IMPACT OF A STRUCTURED YOGA PROGRAM ON BLOOD PRESSURE REDUCTION AMONG HYPERTENSIVE PATIENTS: STUDY PROTOCOL FOR A PRAGMATIC RANDOMIZED MULTICENTER TRIAL IN PRIMARY HEALTH CARE SETTINGS IN NEPAL. BACKGROUND: HYPERTENSION CONTROL REMAINS A MAJOR GLOBAL CHALLENGE. THE BEHAVIORAL APPROACHES RECOMMENDED FOR BLOOD PRESSURE REDUCTION ARE STRESS REDUCTION, INCREASED EXERCISE AND HEALTHY DIETARY HABITS. SOME STUDY FINDINGS SUGGEST THAT YOGA HAS A BENEFICIAL EFFECT IN REDUCING BLOOD PRESSURE. HOWEVER, THE ROLE OF YOGA ON BLOOD PRESSURE HAS RECEIVED LITTLE ATTENTION IN EXISTING HEALTH CARE PRACTICES IN DEVELOPING COUNTRIES. THIS STUDY WILL BE CONDUCTED IN PRIMARY HEALTH CARE FACILITIES IN NEPAL TO ASSESS THE EFFECTIVENESS OF A PRAGMATIC YOGA INTERVENTION TO COMPLEMENT STANDARD PRACTICE IN FURTHER REDUCING BLOOD PRESSURE. METHODS: THIS WILL BE MULTICENTRIC, TWO ARMS, RANDOMIZED, NONBLINDED, PRAGMATIC TRIAL. IT WILL BE CONDUCTED IN SEVEN DISTRICT AYURVEDA HEALTH CENTERS (DAHCS) IN NEPAL BETWEEN JULY 2017 AND JUNE 2018. THE STUDY PARTICIPANTS WILL CONSIST OF HYPERTENSIVE PATIENTS WITH OR WITHOUT ANTIHYPERTENSIVE MEDICATION ATTENDING TO THE OUTPATIENT DEPARTMENT (OPD). ONE HUNDRED AND FORTY PARTICIPANTS WILL BE RANDOMIZED TO TREATMENT OR CONTROL GROUPS BY USING A STRATIFIED BLOCK RANDOMIZATION. AT THE STUDY SITE, THE TREATMENT ARM PARTICIPANTS WILL RECEIVE AN INTERVENTION CONSISTING OF FIVE DAYS OF STRUCTURED YOGA TRAINING AND PRACTICE OF THE SAME PACKAGE AT HOME WITH A RECOMMENDATION OF FIVE DAYS A WEEK FOR THE FOLLOWING 90 DAYS. BOTH THE INTERVENTION AND CONTROL GROUPS WILL RECEIVE TWO HOURS OF HEALTH EDUCATION ON LIFESTYLE MODIFICATIONS. THE PRIMARY OUTCOME OF THIS TRIAL WILL BE THE CHANGE IN SYSTOLIC BLOOD PRESSURE AND IT WILL BE ASSESSED AFTER 90 DAYS OF THE INTERVENTION. DISCUSSION: THIS STUDY WILL ESTABLISH THE EXTENT TO WHICH A YOGA INTERVENTION PACKAGE CAN HELP REDUCE BLOOD PRESSURE IN HYPERTENSIVE PATIENTS. IF PROVEN EFFECTIVE, STUDY FINDINGS MAY BE USED TO RECOMMEND THE GOVERNING BODIES AND OTHER STAKEHOLDERS FOR THE INTEGRATION OF YOGA IN THE NATIONAL HEALTHCARE SYSTEM FOR THE TREATMENT AND CONTROL OF HYPERTENSION. TRIAL REGISTRATION: CLINICAL TRIAL REGISTRY- INDIA (CTRI); CTRI REG. NO- CTRI/2017/02/007822 . REGISTERED ON 10/02/2017. 2018 19 2293 48 THERAPEUTIC EFFICACY OF ADD-ON YOGASANA INTERVENTION IN STABILIZED OUTPATIENT SCHIZOPHRENIA: RANDOMIZED CONTROLLED COMPARISON WITH EXERCISE AND WAITLIST. BACKGROUND: SCHIZOPHRENIA IS A HIGHLY DISABLING ILLNESS. PREVIOUS STUDIES HAVE SHOWN YOGA TO BE A FEASIBLE ADD-ON THERAPY IN SCHIZOPHRENIA. AIMS: THE CURRENT STUDY AIMED TO TEST THE EFFICACY OF YOGA AS AN ADD-ON TREATMENT IN OUTPATIENTS WITH SCHIZOPHRENIA. SETTINGS AND DESIGN: THE STUDY DONE AT A TERTIARY PSYCHIATRY CENTER USED A SINGLE BLIND RANDOMIZED CONTROLLED DESIGN WITH ACTIVE CONTROL AND WAITLIST GROUPS. MATERIALS AND METHODS: CONSENTING PATIENTS WITH SCHIZOPHRENIA WERE RANDOMIZED INTO YOGA, EXERCISE, OR WAITLIST GROUP. THEY CONTINUED TO RECEIVE PHARMACOLOGICAL THERAPY THAT WAS UNCHANGED DURING THE STUDY. PATIENTS IN THE YOGA OR EXERCISE GROUP WERE OFFERED SUPERVISED DAILY PROCEDURES FOR ONE MONTH. ALL PATIENTS WERE ASSESSED BY A BLIND RATER AT THE START OF THE INTERVENTION AND AT THE END OF 4 MONTHS. RESULTS: KENDALL TAU, A NONPARAMETRIC STATISTICAL TEST, SHOWED THAT SIGNIFICANTLY MORE PATIENTS IN THE YOGA GROUP IMPROVED IN POSITIVE AND NEGATIVE SYNDROME SCALE (PANSS) NEGATIVE AND TOTAL PANSS SCORES AS WELL AS SOCIAL FUNCTIONING SCORES COMPARED WITH THE EXERCISE AND WAITLIST GROUP. ODDS RATIO ANALYSIS SHOWED THAT THE LIKELIHOOD OF IMPROVEMENT IN YOGA GROUP IN TERMS OF NEGATIVE SYMPTOMS WAS ABOUT FIVE TIMES GREATER THAN EITHER THE EXERCISE OR WAITLIST GROUPS. CONCLUSION: IN SCHIZOPHRENIA PATIENTS WITH SEVERAL YEARS OF ILLNESS AND ON STABILIZED PHARMACOLOGICAL THERAPY, ONE-MONTH TRAINING FOLLOWED BY THREE MONTHS OF HOME PRACTICES OF YOGA AS AN ADD-ON TREATMENT OFFERED SIGNIFICANT ADVANTAGE OVER EXERCISE OR TREATMENT AS USUAL. YOGA HOLDS PROMISE AS A COMPLEMENTARY INTERVENTION IN THE MANAGEMENT OF SCHIZOPHRENIA. 2012 20 2628 46 YOGA FOR THE MANAGEMENT OF PAIN AND SLEEP IN RHEUMATOID ARTHRITIS: A PILOT RANDOMIZED CONTROLLED TRIAL. OBJECTIVE: THE AIM OF THE PRESENT STUDY WAS TO DETERMINE THE FEASIBILITY OF A RELAXATION-BASED YOGA INTERVENTION FOR RHEUMATOID ARTHRITIS, DESIGNED AND REPORTED IN ACCORDANCE WITH DELPHI RECOMMENDATIONS FOR YOGA INTERVENTIONS FOR MUSCULOSKELETAL CONDITIONS. METHODS: PARTICIPANTS WERE RECRUITED FROM A HOSPITAL DATABASE, AND RANDOMIZED TO EITHER EIGHT WEEKLY 75-MIN YOGA CLASSES OR A USUAL CARE CONTROL. FEASIBILITY WAS DETERMINED BY RECRUITMENT RATES, RETENTION, PROTOCOL ADHERENCE, PARTICIPANT SATISFACTION AND ADVERSE EVENTS. SECONDARY PHYSICAL AND PSYCHOSOCIAL OUTCOMES WERE ASSESSED USING SELF-REPORTED QUESTIONNAIRES AT BASELINE (WEEK 0), WEEK 9 (PRIMARY TIME POINT) AND WEEK 12 (FOLLOW-UP). RESULTS: OVER A 3-MONTH PERIOD, 26 PARTICIPANTS WITH MILD PAIN, MILD TO MODERATE FUNCTIONAL DISABILITY AND MODERATE DISEASE ACTIVITY WERE RECRUITED INTO THE STUDY (25% RECRUITMENT RATE). RETENTION RATES WERE 100% FOR YOGA PARTICIPANTS AND 92% FOR USUAL CARE PARTICIPANTS AT BOTH WEEKS 9 AND 12. PROTOCOL ADHERENCE AND PARTICIPANT SATISFACTION WERE HIGH. YOGA PARTICIPANTS ATTENDED A MEDIAN OF SEVEN CLASSES; ADDITIONALLY, SEVEN OF THE YOGA PARTICIPANTS (54%) REPORTED CONTINUING YOGA AT HOME DURING THE FOLLOW-UP PERIOD. NO SERIOUS ADVERSE EVENTS WERE RELATED TO THE STUDY. SECONDARY OUTCOMES SHOWED NO GROUP EFFECTS OF YOGA COMPARED WITH USUAL CARE. CONCLUSIONS: A RELAXATION-BASED YOGA PROGRAMME WAS FOUND TO BE FEASIBLE AND SAFE FOR PARTICIPANTS WITH RHEUMATOID ARTHRITIS-RELATED PAIN AND FUNCTIONAL DISABILITY. ADVERSE EVENTS WERE MINOR, AND NOT UNEXPECTED FROM AN INTERVENTION INCLUDING PHYSICAL COMPONENTS. THIS PILOT PROVIDES A FRAMEWORK FOR LARGER INTERVENTION STUDIES, AND SUPPORTS FURTHER EXPLORATION OF YOGA AS A COMPLEX INTERVENTION TO ASSIST WITH THE MANAGEMENT OF RHEUMATOID ARTHRITIS. 2018