1 2316 205 TRAUMA-SENSITIVE YOGA FOR POST-TRAUMATIC STRESS DISORDER IN WOMEN VETERANS WHO EXPERIENCED MILITARY SEXUAL TRAUMA: INTERIM RESULTS FROM A RANDOMIZED CONTROLLED TRIAL. OBJECTIVE: TO CONDUCT AN INTERIM ANALYSIS OF DATA COLLECTED FROM AN ONGOING MULTISITE RANDOMIZED CLINICAL TRIAL (RCT) ASSESSING THE EFFECTIVENESS OF TRAUMA CENTER TRAUMA-SENSITIVE YOGA (TCTSY) FOR POST-TRAUMATIC STRESS DISORDER (PTSD) AMONG WOMEN VETERANS WITH PTSD RELATED TO MILITARY SEXUAL TRAUMA (MST). THE PURPOSE OF THE INTERIM ANALYSIS WAS TO ASSESS OUTCOMES FROM THE PRIMARY SITE, WHICH IS GEOGRAPHICALLY, DEMOGRAPHICALLY, CULTURALLY, AND PROCEDURALLY DISTINCT FROM THE SECOND SITE. DESIGN: RCT WAS CONDUCTED WITHIN A VETERANS ADMINISTRATION HEALTH CARE SYSTEM. DATA COLLECTION INCLUDED PREINTERVENTION THROUGH 3 MONTHS POSTINTERVENTION. PARTICIPANTS: ENROLLMENT FOR THE MAIN SITE WAS 152 WOMEN. THE SAMPLE SIZE FOR THE INTENT-TO-TREAT ANALYSIS WAS 104. THE MAJORITY WERE AFRICAN AMERICAN (91.3%) WITH A MEAN AGE OF 48.46 YEARS. INTERVENTION: THE TCTSY INTERVENTION (N = 58) WAS CONDUCTED BY TCTSY-CERTIFIED YOGA FACILITATORS AND CONSISTED OF 10 WEEKLY 60-MIN GROUP SESSIONS. THE CONTROL INTERVENTION, COGNITIVE PROCESSING THERAPY (CPT; N = 46), CONSISTED OF 12 90-MIN WEEKLY GROUP SESSIONS CONDUCTED PER VETERANS ADMINISTRATION PROTOCOL BY CLINICIANS IN THE PTSD CLINIC. OUTCOME MEASURES: THE CLINICIAN ADMINISTERED PTSD SCALE FOR DSM-5 (CAPS-5) WAS USED TO ASSESS CURRENT PTSD DIAGNOSIS AND SYMPTOM SEVERITY, INCLUDING OVERALL PTSD AND FOUR SYMPTOM CLUSTERS. THE PTSD CHECKLIST FOR DSM-5 (PCL-5) WAS USED TO OBTAIN SELF-REPORT OF PTSD SYMPTOM SEVERITY, INCLUDING TOTAL SCORE AND FOUR SYMPTOM CLUSTERS. RESULTS: THE FINDINGS REPORTED HERE ARE INTERIM RESULTS FROM ONE CLINICAL SITE. FOR BOTH THE CAPS-5 AND PCL-5, TOTAL SCORES AND ALL FOUR CRITERION SCORES DECREASED SIGNIFICANTLY (P < 0.01) OVER TIME IN ALL FIVE MULTILEVEL LINEAR MODELS WITHIN BOTH TCTSY AND CPT GROUPS, WITHOUT SIGNIFICANT DIFFERENCES BETWEEN GROUPS. THERE WERE CLINICALLY MEANINGFUL IMPROVEMENTS SEEN FOR BOTH TCTSY AND CPT WITH 51.1%-64.3% OF TCTSY SUBJECTS AND 43.5%-73.7% OF CPT DECREASING THEIR CAPS-5 SCORES BY 10 POINTS OR MORE. EFFECT SIZES FOR TOTAL SYMPTOM SEVERITY WERE LARGE FOR TCTSY (COHEN'S D = 1.10-1.18) AND CPT (COHEN'S D = 0.90-1.40). INTERVENTION COMPLETION WAS HIGHER IN TCTSY (60.3%) THAN IN CPT (34.8%). SYMPTOM IMPROVEMENT OCCURRED EARLIER FOR TCTSY (MIDINTERVENTION) THAN FOR CPT (2 WEEKS POSTINTERVENTION). SAFETY: THERE WERE NO UNANTICIPATED ADVERSE EVENTS IN THIS STUDY. CONCLUSION: THE RESULTS OF THIS STUDY DEMONSTRATE THAT TCTSY MAY BE AN EFFECTIVE TREATMENT FOR PTSD THAT YIELDS SYMPTOM IMPROVEMENT MORE QUICKLY, HAS HIGHER RETENTION THAN CPT, AND HAS A SUSTAINED EFFECT. TCTSY MAY BE AN EFFECTIVE ALTERNATIVE TO TRAUMA-FOCUSED THERAPY FOR WOMEN VETERANS WITH PTSD RELATED TO MST. THE STUDY IS REGISTERED IN CLINICALTRIALS.GOV (CTR NO.: NCT02640690). 2021 2 809 53 EFFECT OF YOGA ON AUTONOMIC FUNCTIONS AND PSYCHOLOGICAL STATUS DURING BOTH PHASES OF MENSTRUAL CYCLE IN YOUNG HEALTHY FEMALES. CONTEXT: PREMENSTRUAL STRESS AFFECTS 75% OF WOMEN OF CHILDBEARING AGE AND YOGA HAS BEEN FOUND TO BE BENEFICIAL IN MANY PSYCHO-SOMATIC DISORDERS. AIMS: TO INVESTIGATE THE EFFECT OF INTEGRATED YOGA ON AUTONOMIC PARAMETERS AND PSYCHOLOGICAL WELL-BEING DURING BOTH PRE AND POST PHASES OF MENSTRUAL CYCLE IN HEALTHY YOUNG FEMALE SUBJECTS. SETTINGS AND DESIGN: PRESENT STUDY IS A RANDOMIZED CONTROL TRIAL AND WAS CONDUCTED IN THE DEPARTMENT OF PHYSIOLOGY, LADY HARDINGE MEDICAL COLLEGE, NEW DELHI, INDIA. MATERIAL AND METHODS: FIFTY APPARENTLY HEALTHY FEMALES IN THE AGE GROUP OF 18-20 YEARS WERE RANDOMIZED INTO TWO GROUPS: GROUP I (N=25) CONSISTED OF SUBJECTS WHO PRACTICED YOGA 35-40 MINUTES PER DAY, SIX TIMES PER WEEK FOR THE DURATION OF THREE MENSTRUAL CYCLES. TRAINING WAS GIVEN BY QUALIFIED YOGA INSTRUCTOR. GROUP II (N=25) SUBJECTS ACTED AS CONTROLS. FOLLOWING PARAMETERS WERE RECORDED AT THE BEGINNING AND AFTER COMPLETION OF THREE MENSTRUAL CYCLES IN ALL THE SUBJECTS: HEIGHT, WEIGHT (BW), RESTING HEART RATE (HR), RESTING SYSTOLIC (SBP) AND DIASTOLIC BLOOD PRESSURE (DBP), PARASYMPATHETIC REACTIVITY TESTS INCLUDING EXPIRATION-INSPIRATION RATIO (E: I RATIO) AND 30:15 RATIO, SYMPATHETIC REACTIVITY TESTS INCLUDING BP CHANGES DUE TO ISOMETRIC HAND GRIP (IHG) EXERCISE, AND COLD PRESSOR TEST (CPT). ASSESSMENT OF PSYCHOLOGICAL STATUS WAS DONE BY ADMINISTERING DIPAS (DEFENSE INSTITUTE OF PHYSIOLOGY AND ALLIED SCIENCES) INVENTORIES OF ANGER SELF REPORT SCALE, TRAIT ANXIETY, SENSE OF WELL-BEING AND DEPRESSION SCALE. STATISTICAL ANALYSIS: INTRA-GROUP COMPARISON OF PHYSIOLOGICAL PARAMETERS WAS DONE BY USING PAIRED 'T' TEST, WHEREAS INTRA-GROUP COMPARISON OF NON-PARAMETERIC DATA SUCH AS SCORES OF ANXIETY, DEPRESSION, ANGER AND SENSE OF WELL-BEING WAS DONE BY WILCOXON SIGNED-RANK TEST. INTER-GROUP COMPARISON OF PARAMETERS WAS DONE BY STUDENTS 'T' TEST FOR PARAMETRIC TESTS AND MANN-WHITNEY 'U' TEST FOR NON-PARAMETERIC TESTS. RESULTS: THERE WAS SIGNIFICANTLY HIGHER BW, RESTING SBP, DBP, SYMPATHETIC ACTIVITY AND BLUNTING OF PARASYMPATHETIC REACTIVITY AND ALSO, SIGNIFICANTLY HIGHER SCORES OF ANGER, DEPRESSION, ANXIETY AND DECREASED SCORE OF WELL-BEING IN PREMENSTRUAL PHASE AS COMPARED TO POSTMENSTRUAL PHASE IN BOTH THE GROUPS IN INITIAL CYCLE. THERE WAS SIGNIFICANTLY HIGHER PERCENTAGE DECREASE IN BW, HR, SBP & DBP IN YOGA GROUP AS COMPARED TO CONTROL GROUP IN BOTH THE PHASES FROM INITIAL TO SECOND AND ONWARDS BETWEEN SECOND AND THIRD MENSTRUAL CYCLE. ALSO, DECREASE IN ANGER, DEPRESSION AND ANXIETY AND INCREASE IN WELL-BEING SCORE WAS SIGNIFICANT IN YOGA GROUP AS COMPARED TO CONTROL GROUP FROM INITIAL TO SECOND AND THIRD CYCLE IN PREMENSTRUAL PHASE WHILE THE CHANGE WAS SIGNIFICANT ONLY IN DEPRESSION SCORE IN POSTMENSTRUAL PHASE. CONCLUSION: OUR STUDY SHOWS THAT THERE WAS SIGNIFICANT ALTERATION OF AUTONOMIC FUNCTIONS AND PSYCHOLOGICAL STATUS IN PREMENSTRUAL PHASE WHEN COMPARED WITH POSTMENSTRUAL PHASE IN YOUNG HEALTHY FEMALES. ALSO, REGULAR PRACTICE OF YOGA HAS BENEFICIAL EFFECTS ON BOTH PHASES OF MENSTRUAL CYCLE BY BRINGING PARASYMPATHODOMINANCE AND PSYCHOLOGICAL WELL-BEING PROBABLY BY BALANCING NEURO-ENDOCRINAL AXIS. 2013 3 2218 40 THE IMPACT OF A YOGA-BASED PHYSICAL THERAPY GROUP FOR INDIVIDUALS WITH TRAUMATIC BRAIN INJURY: RESULTS FROM A PILOT STUDY. OBJECTIVE: TO COMPARE THE IMPACTS OF YOGA-BASED PHYSICAL THERAPY VERSUS A SEATED REST WITHIN THE CONTEXT OF STANDARD REHABILITATION PRACTICE ON SLEEP, HEART RATE VARIABILITY (HRV), ANXIETY, AND FATIGUE DURING ACUTE TRAUMATIC BRAIN INJURY (TBI) REHABILITATION. METHODS: ELEVEN INDIVIDUALS PARTICIPATED IN THIS CROSSOVER STUDY INVOLVING THE FOLLOWING INTERVENTIONS IN A RANDOMIZED ORDER: GROUP YOGA-BASED PHYSICAL THERAPY (YPT), CONVENTIONAL PHYSICAL THERAPY (CPT), AND GROUP SEATED REST IN A RELAXING ENVIRONMENT (SR). HRV AND SELF-REPORTED ANXIETY AND FATIGUE WERE MEASURED IMMEDIATELY BEFORE AND AFTER EACH GROUP, AND SLEEP AFTER EACH CONDITION AND AT BASELINE. DATA WAS ANALYZED USING GENERALIZED LINEAR MIXED MODELS WITH REPEATED MEASURES. RESULTS: THE INTERACTION BETWEEN TIME AND TREATMENT WAS STATISTICALLY SIGNIFICANT (P = .0203). FOR THE SR TREATMENT, WAKE AFTER SLEEP ONSET (WASO) RATE WAS REDUCED FROM 14.99 TO 10.60 (IRR = 0.71; P = .006). TIME AND TREATMENT WERE NOT FOUND TO BE STATISTICALLY SIGNIFICANTLY ASSOCIATED WITH ANY OF THE SECONDARY OUTCOMES. CONCLUSION: YOGA-BASED PHYSICAL THERAPY IS FEASIBLE AND SAFE IN THE INPATIENT REHABILITATION SETTING FOLLOWING TBI. SLEEP QUALITY IMPROVED FOLLOWING THE ADDITION OF A ONE-HOUR SEATED REST IN A RELAXING ENVIRONMENT TO A STANDARD REHABILITATION DAILY SCHEDULE, SUGGESTING THAT STRUCTURED REST TIME MAY BE BENEFICIAL TO SLEEP HYGIENE DURING INPATIENT REHABILITATION FOLLOWING TBI. CLINICALTRIALS.GOV REGISTRATION NUMBER: NCT03701594. 2020 4 1635 52 MODERATORS OF TREATMENT EFFICACY IN A RANDOMIZED CONTROLLED TRIAL OF TRAUMA-SENSITIVE YOGA AS AN ADJUNCTIVE TREATMENT FOR POSTTRAUMATIC STRESS DISORDER. OBJECTIVE: THIS STUDY IS A FOLLOW-UP TO VAN DER KOLK ET AL. (2014), A TRIAL CONDUCTED THROUGH THE TRAUMA CENTER AT JUSTICE RESOURCE INSTITUTE, WHICH DEMONSTRATED TREATMENT EFFICACY AND REMAINS THE ONLY RANDOMIZED CONTROLLED TRIAL OF TRAUMA-SENSITIVE YOGA. THE PRESENT PROCESS STUDY EXTENDS THE OUTCOMES STUDY BY EXAMINING TREATMENT MODERATORS OF THE ORIGINAL TRIAL. METHOD: SIXTY-FOUR WOMEN WITH CHILDHOOD INTERPERSONAL TRAUMA HISTORIES AND POSTTRAUMATIC STRESS DISORDER PARTICIPATED IN THE INTERVENTIONS: TRAUMA CENTER TRAUMA-SENSITIVE YOGA (TCTSY) VERSUS ACTIVE CONTROL (WOMEN'S HEALTH EDUCATION). ANALYSES EXPLORED IF ADULT-ONSET INTERPERSONAL TRAUMA AND BASELINE PSYCHOLOGICAL MEASURES (CLINICIAN-RATED AND SELF-REPORTED PTSD, DISSOCIATION, DEPRESSION, PSYCHOLOGICAL FUNCTIONING) MODERATED PTSD CHANGES. RESULTS: THREE OF SIX MEASURES HAD SMALL EFFECTS IN MODERATING THE RELATIONSHIP BETWEEN ADULT-ONSET INTERPERSONAL TRAUMA AND TCTSY EFFICACY, IN WHICH TCTSY WAS MOST EFFICACIOUS FOR THOSE WITH FEWER ADULT-ONSET INTERPERSONAL TRAUMAS. WITHIN THIS SUBGROUP, VARIOUS LEVELS OF ALL BASELINE MEASURES EXCEPT DEPRESSION INDICATED THAT TCTSY WAS MORE EFFECTIVE IN REDUCING PTSD THAN THE ACTIVE CONTROL CONDITION. CONCLUSIONS: BY DELINEATING CLIENT CHARACTERISTICS MOST ASSOCIATED WITH PTSD IMPROVEMENTS, PRACTITIONERS MAY BEST TARGET YOGA INTERVENTIONS TO INCREASE EFFECTIVENESS. (PSYCINFO DATABASE RECORD (C) 2020 APA, ALL RIGHTS RESERVED). 2020 5 2831 45 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 6 518 47 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 7 2852 51 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 8 1352 45 IMMEDIATE EFFECT OF MIND SOUND RESONANCE TECHNIQUE (MSRT - A YOGA-BASED RELAXATION TECHNIQUE) ON BLOOD PRESSURE, HEART RATE, AND STATE ANXIETY IN INDIVIDUALS WITH HYPERTENSION: A PILOT STUDY. BACKGROUND MIND SOUND RESONANCE TECHNIQUE (MSRT) IS A YOGA-BASED RELAXATION TECHNIQUE. PREVIOUS STUDIES ON MSRT DEMONSTRATED ITS POTENTIAL HEALTH-BENEFITING EFFECTS IN BOTH CLINICAL AND NONCLINICAL POPULATION. PRESENT STUDY INTENDED TO ASSESS THE ACUTE EFFECT OF MSRT INTERVENTION ON BLOOD PRESSURE, HEART RATE (HR), AND STATE ANXIETY IN PATIENTS WITH ESSENTIAL HYPERTENSION (HTN). METHODS THIRTY PARTICIPANTS (13 FEMALES) WITH HTN, WITHIN THE AGE RANGE 30-60 YEARS (WITH MEAN+/-SD: 57.23+/-11.3 YEARS), WHO VISITED SVYASA UNIVERSITY CAMPUS TO ATTEND 1-WEEK RESIDENTIAL YOGA PROGRAM FOR HTN TREATMENT, WERE CONSIDERED FOR THIS STUDY BASED ON INCLUSION AND EXCLUSION CRITERIA. ALL PARTICIPANTS RECEIVED A 4-DAY MSRT ORIENTATION SESSIONS PRIOR TO THE STUDY. EACH PARTICIPANT UNDERWENT 30-MIN SESSION OF BOTH MSRT AND SUPINE REST (SR) ON 2 SUCCESSIVE DAYS. SYSTOLIC AND DIASTOLIC BLOOD PRESSURES, PULSE RATE, AND STATE ANXIETY WERE MEASURED BEFORE AND IMMEDIATELY AFTER BOTH MSRT AND SR SESSIONS. DATA WERE ANALYZED USING SPSS VERSION 16. REPEATED-MEASURE ANALYSIS OF VARIANCE WAS APPLIED TO ASSESS WITHIN-SUBJECTS CHANGES. RESULTS AFTER MSRT SESSION, SIGNIFICANT DECREASE IN SYSTOLIC BLOOD PRESSURE (SBP), DIASTOLIC BLOOD PRESSURE (DBP), HR, AND STATE ANXIETY WAS OBSERVED COMPARED TO BASELINE. SIMILARLY, AFTER SR SESSION, SIGNIFICANT CHANGES WERE FOUND IN HR AND STATE ANXIETY. NO SIGNIFICANT CHANGE WAS SEEN IN SBP AND DBP FOLLOWING SR COMPARED TO SR SESSION; MSRT SESSION SHOWED SIGNIFICANTLY BETTER IMPROVEMENT IN SBP, DBP, HR, AND STATE ANXIETY. CONCLUSION PRESENT STUDY DEMONSTRATED THE USEFULNESS OF SINGLE SESSION OF MSRT IN REDUCING BLOOD PRESSURE, HR, AND STATE ANXIETY AMONG INDIVIDUALS WITH HTN AS COMPARED TO SR. THESE FINDINGS ENCOURAGE THE FURTHER STUDIES WITH LARGER SAMPLE SIZE AND LONG-TERM INTERVENTION WITH A ROBUST RESEARCH DESIGN. 2018 9 1541 53 KRIPALU YOGA FOR MILITARY VETERANS WITH PTSD: A RANDOMIZED TRIAL. OBJECTIVES: THIS RANDOMIZED CONTROLLED TRIAL OF YOGA FOR MILITARY VETERANS AND ACTIVE DUTY PERSONNEL WITH POSTTRAUMATIC STRESS DISORDER (PTSD) EVALUATED THE EFFICACY OF A 10-WEEK YOGA INTERVENTION ON PTSD. METHOD: FIFTY-ONE PARTICIPANTS WERE RANDOMIZED INTO YOGA OR NO-TREATMENT ASSESSMENT-ONLY CONTROL GROUPS. PRIMARY OUTCOME MEASURES INCLUDED QUESTIONNAIRES AND THE CLINICIAN ADMINISTERED PTSD SCALE. RESULTS: BOTH YOGA (N = 9) AND CONTROL (N = 6) PARTICIPANTS SHOWED SIGNIFICANT DECREASES IN REEXPERIENCING SYMPTOMS, WITH NO SIGNIFICANT BETWEEN-GROUP DIFFERENCES. SECONDARY WITHIN-GROUP ANALYSES OF A SELF-SELECTED WAIT-LIST YOGA GROUP (N = 7) SHOWED SIGNIFICANT REDUCTIONS IN PTSD SYMPTOMS AFTER YOGA PARTICIPATION, IN CONTRAST TO THEIR CONTROL GROUP PARTICIPATION. CONSISTENT WITH CURRENT LITERATURE REGARDING HIGH RATES OF PTSD TREATMENT DROPOUT FOR VETERANS, THIS STUDY FACED CHALLENGES RETAINING PARTICIPANTS ACROSS CONDITIONS. CONCLUSION: THESE RESULTS ARE CONSISTENT WITH RECENT LITERATURE INDICATING THAT YOGA MAY HAVE POTENTIAL AS A PTSD THERAPY IN A VETERAN OR MILITARY POPULATION. HOWEVER, ADDITIONAL LARGER SAMPLE SIZE TRIALS ARE NECESSARY TO CONFIRM THIS CONCLUSION. 2018 10 388 54 BENEFITS OF THE RESTORATIVE EXERCISE AND STRENGTH TRAINING FOR OPERATIONAL RESILIENCE AND EXCELLENCE YOGA PROGRAM FOR CHRONIC LOW BACK PAIN IN SERVICE MEMBERS: A PILOT RANDOMIZED CONTROLLED TRIAL. OBJECTIVE: TO EXAMINE THE FEASIBILITY AND PRELIMINARY EFFECTIVENESS OF AN INDIVIDUALIZED YOGA PROGRAM. DESIGN: PILOT RANDOMIZED CONTROLLED TRIAL. SETTING: MILITARY MEDICAL CENTER. PARTICIPANTS: PATIENTS (N=68) WITH CHRONIC LOW BACK PAIN. INTERVENTIONS: RESTORATIVE EXERCISE AND STRENGTH TRAINING FOR OPERATIONAL RESILIENCE AND EXCELLENCE (RESTORE) PROGRAM (9-12 INDIVIDUAL YOGA SESSIONS) OR TREATMENT AS USUAL (CONTROL) FOR AN 8-WEEK PERIOD. MAIN OUTCOME MEASURES: THE PRIMARY OUTCOME WAS PAST 24-HOUR PAIN (DEFENSE & VETERANS PAIN RATING SCALE 2.0). SECONDARY OUTCOMES INCLUDED DISABILITY (ROLAND-MORRIS DISABILITY QUESTIONNAIRE) AND PHYSICAL FUNCTIONING AND SYMPTOM BURDEN (PATIENT-REPORTED OUTCOMES MEASUREMENT INFORMATION SYSTEM-29 SUBSCALES). ASSESSMENT OCCURRED AT BASELINE, WEEK 4, WEEK 8, 3-MONTH FOLLOW-UP, AND 6-MONTH FOLLOW-UP. EXPLORATORY OUTCOMES INCLUDED THE PROPORTION OF PARTICIPANTS IN EACH GROUP REPORTING CLINICALLY MEANINGFUL CHANGES AT 3- AND 6-MONTH FOLLOW-UPS. RESULTS: GENERALIZED LINEAR MIXED MODELS WITH SEQUENTIAL BONFERRONI-ADJUSTED PAIRWISE SIGNIFICANCE TESTS AND CHI-SQUARE ANALYSES EXAMINED LONGITUDINAL OUTCOMES. SECONDARY OUTCOME SIGNIFICANCE TESTS WERE BONFERRONI ADJUSTED FOR MULTIPLE OUTCOMES. THE RESTORE GROUP REPORTED IMPROVED PAIN COMPARED WITH THE CONTROL GROUP. SECONDARY OUTCOMES DID NOT RETAIN SIGNIFICANCE AFTER BONFERRONI ADJUSTMENTS FOR MULTIPLE OUTCOMES, ALTHOUGH A HIGHER PROPORTION OF RESTORE PARTICIPANTS REPORTED CLINICALLY MEANINGFULLY CHANGES IN ALL OUTCOMES AT 3-MONTH FOLLOW-UP AND IN SYMPTOM BURDEN AT 6-MONTH FOLLOW-UP. CONCLUSIONS: RESTORE MAY BE A VIABLE NONPHARMACOLOGICAL TREATMENT FOR LOW BACK PAIN WITH MINIMAL SIDE EFFECTS, AND RESEARCH EFFORTS ARE NEEDED TO COMPARE THE EFFECTIVENESS OF RESTORE DELIVERY FORMATS (EG, GROUP VS INDIVIDUAL) WITH THAT OF OTHER TREATMENT MODALITIES. 2018 11 2851 54 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 12 945 59 EFFECTS OF A 12-WEEK YOGA VERSUS A 12-WEEK EDUCATIONAL FILM INTERVENTION ON SYMPTOMS OF RESTLESS LEGS SYNDROME AND RELATED OUTCOMES: AN EXPLORATORY RANDOMIZED CONTROLLED TRIAL. STUDY OBJECTIVES: TO ASSESS THE EFFECTS OF A YOGA VERSUS EDUCATIONAL FILM (EF) PROGRAM ON RESTLESS LEGS SYNDROME (RLS) SYMPTOMS AND RELATED OUTCOMES IN ADULTS WITH RLS. METHODS: FORTY-ONE COMMUNITY-DWELLING, AMBULATORY NONPREGNANT ADULTS WITH MODERATE TO SEVERE RLS WERE RANDOMIZED TO A 12-WEEK YOGA (N = 19) OR EF PROGRAM (N = 22). IN ADDITION TO ATTENDING CLASSES, ALL PARTICIPANTS COMPLETED PRACTICE/TREATMENT LOGS. YOGA GROUP PARTICIPANTS WERE ASKED TO PRACTICE AT HOME 30 MINUTES PER DAY ON NONCLASS DAYS; EF PARTICIPANTS WERE INSTRUCTED TO RECORD ANY RLS TREATMENTS USED ON THEIR DAILY LOGS. CORE OUTCOMES ASSESSED PRETREATMENT AND POSTTREATMENT WERE RLS SYMPTOMS AND SYMPTOM SEVERITY (INTERNATIONAL RLS STUDY GROUP SCALE (IRLS) AND RLS ORDINAL SCALE), SLEEP QUALITY, MOOD, PERCEIVED STRESS, AND QUALITY OF LIFE (QOL). RESULTS: THIRTY ADULTS (13 YOGA, 17 EF), AGED 24 TO 73 (MEAN = 50.4 +/- 2.4 YEARS), COMPLETED THE 12-WEEK STUDY (78% FEMALE, 80.5% WHITE). POST-INTERVENTION, BOTH GROUPS SHOWED SIGNIFICANT IMPROVEMENT IN RLS SYMPTOMS AND SEVERITY, PERCEIVED STRESS, MOOD, AND QOL-MENTAL HEALTH (P /=12 WEEKS: YOGA (N=27), PT (N=26). METHODS: YOGA PARTICIPANTS ATTENDED A 6-WEEK, ONCE WEEKLY, 2-HOUR YOGA CLASS. PT PARTICIPANTS UNDERWENT TWICE WEEKLY, 1-HOUR INDIVIDUALIZED PT. DATA WERE COLLECTED AT BASELINE AND AT 6 WEEKS. GROUPS WERE COMPARED BY USING CHI2 AND INDEPENDENT SAMPLES T-TESTS. HIERARCHICAL LINEAR REGRESSION WAS USED TO PREDICT TREATMENT OUTCOMES. MAIN OUTCOME MEASURES: DISABILITY (ROLAND MORRIS DISABILITY QUESTIONNAIRE), HEALTH STATUS (RAND SHORT FORM 36 HEALTH SURVEY 1.0), PAIN BOTHERSOMENESS (NUMERICAL RATING SCALE), BACK PAIN SELF-EFFICACY (BACK PAIN SELF-EFFICACY SCALE), AND TREATMENT SATISFACTION. RESULTS: AT BASELINE, YOGA PARTICIPANTS WERE SIGNIFICANTLY LESS DISABLED (P=.013), HAD HIGHER HEALTH STATUS (P=.023), GREATER PAIN SELF-EFFICACY (P=.012), AND LESS AVERAGE PAIN BOTHERSOMENESS (P=.001) COMPARED WITH PT PARTICIPANTS. AT 6 WEEKS, WHEN CONTROLLING FOR BASELINE GROUP DIFFERENCES, GREATER PAIN SELF-EFFICACY WAS THE STRONGEST PREDICTOR FOR REDUCED PAIN AND HIGHER FUNCTION FOR THE ENTIRE SAMPLE. A SIGNIFICANT GROUP INTERACTION BY BASELINE PAIN SELF-EFFICACY PREDICTED DISABILITY AT 6 WEEKS. PT PARTICIPANTS WITH LOW PAIN SELF-EFFICACY REPORTED SIGNIFICANTLY GREATER DISABILITY THAN THOSE WITH HIGH PAIN SELF-EFFICACY. YOGA PARTICIPANTS WITH LOW AND HIGH PAIN SELF-EFFICACY HAD SIMILAR DISABILITY OUTCOMES. CONCLUSION: THESE FINDINGS STRENGTHEN EVIDENCE THAT SELF-EFFICACY IS ASSOCIATED WITH CLBP OUTCOMES, ESPECIALLY IN INDIVIDUALS SELF-SELECTING PT. FURTHER RESEARCH TO EVALUATE OUTCOMES AFTER YOGA AND PT IN PARTICIPANTS WITH LOW PAIN SELF-EFFICACY IS NEEDED. 2010 15 2824 52 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 16 521 55 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 17 2596 63 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 18 461 50 CHANGES IN PERCEIVED STRESS AFTER YOGA, PHYSICAL THERAPY, AND EDUCATION INTERVENTIONS FOR CHRONIC LOW BACK PAIN: A SECONDARY ANALYSIS OF A RANDOMIZED CONTROLLED TRIAL. OBJECTIVE: PERCEIVED STRESS AND MUSCULOSKELETAL PAIN ARE COMMON, ESPECIALLY IN LOW-INCOME POPULATIONS. STUDIES EVALUATING TREATMENTS TO REDUCE STRESS IN PATIENTS WITH CHRONIC PAIN ARE LACKING. WE AIMED TO QUANTIFY THE EFFECT OF TWO EVIDENCE-BASED INTERVENTIONS FOR CHRONIC LOW BACK PAIN (CLBP), YOGA AND PHYSICAL THERAPY (PT), ON PERCEIVED STRESS IN ADULTS WITH CLBP. METHODS: WE USED DATA FROM AN ASSESSOR-BLINDED, PARALLEL-GROUP RANDOMIZED CONTROLLED TRIAL, WHICH RECRUITED PREDOMINANTLY LOW-INCOME AND RACIALLY DIVERSE ADULTS WITH CLBP. PARTICIPANTS (N = 320) WERE RANDOMLY ASSIGNED TO 12 WEEKS OF YOGA, PT, OR BACK PAIN EDUCATION. WE COMPARED CHANGES IN THE 10-ITEM PERCEIVED STRESS SCALE (PSS-10) FROM BASELINE TO 12- AND 52-WEEK FOLLOW-UP AMONG YOGA AND PT PARTICIPANTS WITH THOSE RECEIVING EDUCATION. SUBANALYSES WERE CONDUCTED FOR PARTICIPANTS WITH ELEVATED PRE-INTERVENTION PERCEIVED STRESS (PSS-10 SCORE >/=17). WE CONDUCTED SENSITIVITY ANALYSES USING VARIOUS IMPUTATION METHODS TO ACCOUNT FOR POTENTIAL BIASES IN OUR ESTIMATES DUE TO MISSING DATA. RESULTS: AMONG 248 PARTICIPANTS (MEAN AGE = 46.4 YEARS, 80% NONWHITE) COMPLETING ALL THREE SURVEYS, YOGA AND PT SHOWED GREATER REDUCTIONS IN PSS-10 SCORES COMPARED WITH EDUCATION AT 12 WEEKS (MEAN BETWEEN-GROUP DIFFERENCE = -2.6, 95% CONFIDENCE INTERVAL [CI] = -4.5 TO -0.66, AND MEAN BETWEEN-GROUP DIFFERENCE = -2.4, 95% CI = -4.4 TO -0.48, RESPECTIVELY). THIS EFFECT WAS STRONGER AMONG PARTICIPANTS WITH ELEVATED PRE-INTERVENTION PERCEIVED STRESS. BETWEEN-GROUP EFFECTS HAD ATTENUATED BY 52 WEEKS. RESULTS WERE SIMILAR IN SENSITIVITY ANALYSES. CONCLUSIONS: YOGA AND PT WERE MORE EFFECTIVE THAN BACK PAIN EDUCATION FOR REDUCING PERCEIVED STRESS AMONG LOW-INCOME ADULTS WITH CLBP. 2020 19 2560 59 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 20 162 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