1 2851 163 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  
2  388  49 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        
3 2852  74 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  
4 2638  46 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    
5 2831  56 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 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              
7  156  32 A QUALITATIVE STUDY OF LOVEYOURBRAIN YOGA: A GROUP-BASED YOGA WITH PSYCHOEDUCATION INTERVENTION TO FACILITATE COMMUNITY INTEGRATION FOR PEOPLE WITH TRAUMATIC BRAIN INJURY AND THEIR CAREGIVERS. PURPOSE: TO EXPLORE PARTICIPANTS' EXPERIENCES IN A GROUP-BASED YOGA WITH PSYCHOEDUCATION INTERVENTION DESIGNED TO FACILITATE COMMUNITY INTEGRATION FOR PEOPLE WITH TRAUMATIC BRAIN INJURY AND THEIR CAREGIVERS.MATERIALS AND METHODS: WE CONDUCTED SEMI-STRUCTURED INTERVIEWS WITH 13 PEOPLE WITH TRAUMATIC BRAIN INJURY AND THREE CAREGIVERS WHO HAD COMPLETED LOVEYOURBRAIN YOGA, A 6-SESSION, MANUALIZED, GROUP-BASED YOGA INTERVENTION THAT INCORPORATES BREATHING EXERCISES, YOGA, MEDITATION, AND PSYCHOEDUCATION. INTERVIEWS WERE ANALYZED USING CONTENT ANALYSIS.RESULTS: WE IDENTIFIED SEVEN THEMES: EASE OF PARTICIPATION, BELONGING, SUSTAINING COMMUNITY CONNECTION, PHYSICAL HEALTH, SELF-REGULATION, SELF-EFFICACY, AND RESILIENCE. ALL PARTICIPANTS VALUED THE COMMUNITY-BASED YOGA STUDIO ENVIRONMENT AND MULTIFACETED STRUCTURE OF THE PROGRAM. PARTICIPANTS REPORTED IMPROVEMENTS IN STRENGTH, BALANCE, FLEXIBILITY, AND ATTENTION CONTROL, AND A GREATER SENSE OF BELONGING, COMMUNITY CONNECTION, AND ABILITY TO MOVE FORWARD WITH THEIR LIVES. PARTICIPANTS REPORTED ONGOING USE OF TOOLS (E.G., BREATHING EXERCISES) TO COPE WITH NEGATIVE EMOTIONS AND STRESS. ABOUT HALF OF PARTICIPANTS SUSTAINED RELATIONSHIPS BUILT DURING LOVEYOURBRAIN YOGA AND FELT MORE CAPABLE OF ACCESSING OTHER ACTIVITIES IN THEIR COMMUNITY.CONCLUSIONS: LOVEYOURBRAIN YOGA SUCCESSFULLY PROMOTED COMMUNITY INTEGRATION FOR PEOPLE WITH TRAUMATIC BRAIN INJURY. IT ALSO FACILITATED DIVERSE AND MEANINGFUL PHYSICAL, PSYCHOLOGICAL, AND SOCIAL HEALTH BENEFITS, WHICH SUGGEST THAT IT MAY BE AN EFFECTIVE MODE OF COMMUNITY-BASED REHABILITATION.IMPLICATIONS FOR REHABILITATIONTRAUMATIC BRAIN INJURY SURVIVORS OFTEN STRUGGLE TO PARTICIPATE IN THEIR COMMUNITY, THE ULTIMATE GOAL OF REHABILITATIONYOGA IS A HOLISTIC THERAPY WITH MANY BENEFITS, YET IS NOT ACCESSIBLE TO THE TRAUMATIC BRAIN INJURY POPULATION AT THE COMMUNITY LEVELPARTICIPANTS IN A COMMUNITY-BASED YOGA WITH PSYCHOEDUCATION INTERVENTION IN SIX STATES EXPERIENCED DIVERSE AND MEANINGFUL PHYSICAL, PSYCHOLOGICAL, AND SOCIAL HEALTH BENEFITSGROUP-BASED YOGA WITH PSYCHOEDUCATION MAY BE AN EFFECTIVE MODE OF COMMUNITY INTEGRATION AND COMMUNITY-BASED REHABILITATION FOR TRAUMATIC BRAIN INJURY SURVIVORS.	2020	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     
8  461  67 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              
9 2824  43 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              
10 1379  43 IMPACT OF IYENGAR YOGA ON QUALITY OF LIFE IN YOUNG WOMEN WITH RHEUMATOID ARTHRITIS. OBJECTIVE: RHEUMATOID ARTHRITIS (RA) IS A CHRONIC, DISABLING DISEASE THAT CAN GREATLY COMPROMISE HEALTH-RELATED QUALITY OF LIFE (HRQOL). THE AIM OF THIS STUDY WAS TO ASSESS THE IMPACT OF A 6-WEEK TWICE/WEEK IYENGAR YOGA PROGRAM ON HRQOL OF YOUNG ADULTS WITH RA COMPARED WITH A USUAL-CARE WAITLIST CONTROL GROUP. METHODS: THE PROGRAM WAS DESIGNED TO IMPROVE THE PRIMARY OUTCOME OF HRQOL INCLUDING PAIN AND DISABILITY AND PSYCHOLOGICAL FUNCTIONING IN PATIENTS. ASSESSMENTS WERE COLLECTED PRETREATMENT, POSTTREATMENT, AND AT 2 MONTHS AFTER TREATMENT. WEEKLY RATINGS OF ANXIETY, DEPRESSION, PAIN, AND SLEEP WERE ALSO RECORDED. A TOTAL OF 26 PARTICIPANTS COMPLETED THE INTERVENTION (YOGA=11; USUAL-CARE WAITLIST=15). ALL PARTICIPANTS WERE FEMALE (MEAN AGE=28 Y). RESULTS: OVERALL ATTRITION WAS LOW AT 15%. ON AVERAGE, WOMEN IN THE YOGA GROUP ATTENDED 96% OF THE YOGA CLASSES. NO ADVERSE EVENTS WERE REPORTED. RELATIVE TO THE USUAL-CARE WAITLIST, WOMEN ASSIGNED TO THE YOGA PROGRAM SHOWED SIGNIFICANTLY GREATER IMPROVEMENT ON STANDARDIZED MEASURES OF HRQOL, PAIN DISABILITY, GENERAL HEALTH, MOOD, FATIGUE, ACCEPTANCE OF CHRONIC PAIN, AND SELF-EFFICACY REGARDING PAIN AT POSTTREATMENT. ALMOST HALF OF THE YOGA GROUP REPORTED CLINICALLY MEANINGFUL SYMPTOM IMPROVEMENT. ANALYSIS OF THE UNCONTROLLED EFFECTS AND MAINTENANCE OF TREATMENT EFFECTS SHOWED IMPROVEMENTS IN HRQOL GENERAL HEALTH, PAIN DISABILITY, AND WEEKLY RATINGS OF PAIN, ANXIETY, AND DEPRESSION WERE MAINTAINED AT FOLLOW-UP. CONCLUSIONS: THE FINDINGS SUGGEST THAT A BRIEF IYENGAR YOGA INTERVENTION IS A FEASIBLE AND SAFE ADJUNCTIVE TREATMENT FOR YOUNG PEOPLE WITH RA, LEADING TO HRQOL, PAIN DISABILITY, FATIGUE, AND MOOD BENEFITS. MOREOVER, IMPROVEMENTS IN QUALITY OF LIFE, PAIN DISABILITY, AND MOOD PERSISTED AT THE 2-MONTH FOLLOW-UP.	2013	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               
11 1953  48 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               
12 2316  54 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	

13  478  41 CLINICAL CASE REPORT: YOGA FOR FATIGUE IN FIVE YOUNG ADULT SURVIVORS OF CHILDHOOD CANCER. PURPOSE: CANCER-RELATED FATIGUE (CRF) IS A DISTRESSING CONSEQUENCE OF CANCER AND ITS TREATMENT. CRF IMPACTS MANY YOUNG ADULT (YA) SURVIVORS OF CHILDHOOD CANCER, COMPROMISING WORK, SOCIAL RELATIONSHIPS, AND DAILY ACTIVITIES. NO SATISFACTORY TREATMENT EXISTS. THIS PILOT STUDY AIMED TO ASSESS THE FEASIBILITY, SAFETY, AND PRELIMINARY EFFICACY OF AN 8-WEEK TWICE/WEEK IYENGAR YOGA (IY) INTERVENTION FOR TREATING PERSISTENT FATIGUE IN YA SURVIVORS OF CHILDHOOD CANCER. METHODS: USING A SINGLE-ARM MIXED-METHODS DESIGN, ADULT CHILDHOOD CANCER SURVIVORS AGED BETWEEN 18 AND 39 YEARS WERE RECRUITED FROM A SURVIVORSHIP CLINIC AT A SINGLE INSTITUTION. QUANTITATIVE: THE PRIMARY OUTCOME WAS FATIGUE AS MEASURED BY THE FUNCTIONAL ASSESSMENT OF CHRONIC ILLNESS THERAPY-FATIGUE. SECONDARY OUTCOMES INCLUDED VITALITY, SOCIAL FUNCTIONING, MULTIDIMENSIONAL FATIGUE, MOOD, AND SLEEP. WEEKLY SELF-REPORT MONITORING DATA WERE COLLECTED. QUALITATIVE: PARTICIPANTS ALSO COMPLETED A POST-INTERVENTION INTERVIEW, MAJOR THEMES EVALUATED. RESULTS: FIVE PARTICIPANTS ENROLLED INTO THE STUDY AND FOUR COMPLETED THE INTERVENTION. ATTENDANCE WAS 92% AND THERE WERE NO ADVERSE EVENTS. BASELINE MOBILITY WAS HIGHLY VARIED, WITH ONE YA HAVING HAD A HEMIPELVECTOMY. QUANTITATIVE DATA REVEALED SIGNIFICANTLY IMPROVED FATIGUE, SOCIAL FUNCTIONING, SOMATIZATION, AND GENERAL AND EMOTIONAL MANIFESTATIONS OF FATIGUE FOLLOWING YOGA. QUALITATIVE DATA CROSS VALIDATED, CLARIFIED, AND EXPANDED UPON THE QUANTITATIVE FINDINGS. CONCLUSIONS: THE STUDY SUGGESTS THAT A BRIEF IY INTERVENTION IS SAFE FOR YA SURVIVORS OF CHILDHOOD CANCER, EVEN FOR THOSE WITH PHYSICAL DISABILITIES. PRELIMINARY EFFICACY WAS DEMONSTRATED FOR THE PRIMARY OUTCOME OF FATIGUE. QUALITATIVE DATA ELUCIDATED ADDITIONAL IMPROVEMENTS, SUCH AS WORK-RELATED SOCIAL FUNCTIONING, AND A SENSE OF CALM AND RELAXATION.	2017	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        
14  518  52 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         
15  465  52 CHARACTERISTICS AND PREDICTORS OF SHORT-TERM OUTCOMES IN INDIVIDUALS SELF-SELECTING YOGA OR PHYSICAL THERAPY FOR TREATMENT OF CHRONIC LOW BACK PAIN. OBJECTIVE: TO COMPARE CLINICAL AND DEMOGRAPHIC CHARACTERISTICS OF INDIVIDUALS SELF-SELECTING YOGA OR PHYSICAL THERAPY (PT) FOR TREATMENT OF CHRONIC LOW BACK PAIN (CLBP) AND TO EXAMINE PREDICTORS OF SHORT-TERM PAIN AND FUNCTIONAL OUTCOMES. DESIGN: DESCRIPTIVE, LONGITUDINAL STUDY. SETTINGS: A HOSPITAL-BASED CLINIC THAT OFFERS MODIFIED INTEGRAL YOGA CLASSES FOR CLBP AND 2 OUTPATIENT PT CLINICS THAT OFFER EXERCISE-BASED PT. PARTICIPANTS: ADULTS (N=53) WITH CLBP>/=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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           
16  430  89 CAN YOGA OR PHYSICAL THERAPY FOR CHRONIC LOW BACK PAIN IMPROVE DEPRESSION AND ANXIETY AMONG ADULTS FROM A RACIALLY DIVERSE, LOW-INCOME COMMUNITY? A SECONDARY ANALYSIS OF A RANDOMIZED CONTROLLED TRIAL. OBJECTIVE: TO DETERMINE AND COMPARE THE EFFECT OF YOGA, PHYSICAL THERAPY (PT), AND EDUCATION ON DEPRESSIVE AND ANXIOUS SYMPTOMS IN PATIENTS WITH CHRONIC LOW BACK PAIN (CLBP). DESIGN: SECONDARY ANALYSIS OF A RANDOMIZED CONTROLLED TRIAL. SETTING: ACADEMIC SAFETY NET HOSPITAL AND 7 COMMUNITY HEALTH CENTERS. PARTICIPANTS: A TOTAL OF 320 ADULTS WITH CLBP. INTERVENTION: YOGA CLASSES, PT SESSIONS, OR AN EDUCATIONAL BOOK. OUTCOME MEASURE: DEPRESSION AND ANXIETY WERE MEASURED USING THE PATIENT HEALTH QUESTIONNAIRE AND GENERALIZED ANXIETY DISORDER 7-ITEM SCALE, RESPECTIVELY, AT BASELINE, 12, AND 52 WEEKS. WE IDENTIFIED BASELINE AND MIDTREATMENT (6-WK) FACTORS ASSOCIATED WITH CLINICALLY MEANINGFUL IMPROVEMENTS IN DEPRESSIVE (>/=3 POINTS) OR ANXIOUS (>/=2 POINTS) SYMPTOMS AT 12 WEEKS. RESULTS: PARTICIPANTS (FEMALE=64%; MEAN AGE, 46.0+/-10.7 YEARS) WERE PREDOMINANTLY NON-WHITE (82%), LOW-INCOME (<$30,000/YEAR, 59%), AND HAD NOT RECEIVED A COLLEGE DEGREE (71%). MOST PARTICIPANTS HAD MILD OR WORSE DEPRESSIVE (60%) AND ANXIOUS (50%) SYMPTOMS. AT 12 WEEKS, YOGA AND PT PARTICIPANTS EXPERIENCED MODEST WITHIN-GROUP IMPROVEMENTS IN DEPRESSIVE SYMPTOMS (MEAN DIFFERENCE [MD]=-1.23 [95% CI, -2.18 TO -0.28]; MD=-1.01 [95% CI, -2.05 TO -0.03], RESPECTIVELY). COMPARED WITH THE EDUCATION GROUP, 12-WEEK DIFFERENCES WERE NOT STATISTICALLY SIGNIFICANT, ALTHOUGH TRENDS FAVORED YOGA (MD=-0.71 [95% CI, -2.22 TO 0.81]) AND PT (MD= -0.32 [95% CI, -1.82 TO 1.18]). AT 12 WEEKS, IMPROVEMENTS IN ANXIOUS SYMPTOMS WERE ONLY FOUND IN PARTICIPANTS WHO HAD MILD OR MODERATE ANXIETY AT BASELINE. INDEPENDENT OF TREATMENT ARM, PARTICIPANTS WHO HAD 30% OR GREATER IMPROVEMENT IN PAIN OR FUNCTION MIDTREATMENT WERE MORE LIKELY TO HAVE A CLINICALLY MEANINGFUL IMPROVEMENT IN DEPRESSIVE SYMPTOMS (ODDS RATIO [OR], 1.82 [95% CI, 1.03-3.22]; OR, 1.79 [95% CI, 1.06-3.04], RESPECTIVELY). CONCLUSIONS: IN OUR SECONDARY ANALYSIS WE FOUND THAT DEPRESSION AND ANXIETY, COMMON IN THIS SAMPLE OF UNDERSERVED ADULTS WITH CLBP, MAY IMPROVE MODESTLY WITH PT AND YOGA. HOWEVER, EFFECTS WERE NOT SUPERIOR TO EDUCATION. IMPROVEMENTS IN PAIN AND FUNCTION ARE ASSOCIATED WITH A DECREASE IN DEPRESSIVE SYMPTOMS. MORE RESEARCH IS NEEDED TO OPTIMIZE THE INTEGRATION OF PHYSICAL AND PSYCHOLOGICAL WELL-BEING IN PT AND YOGA.	2021	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                  
17 1787  51 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 1699  61 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            
19 1746  41 PILOT EVALUATION OF AN IYENGAR YOGA PROGRAM FOR BREAST CANCER SURVIVORS. BACKGROUND: WITH CONTINUAL IMPROVEMENTS IN SCREENING UPTAKE AND ADJUVANT CANCER TREATMENTS, THE NUMBER OF CANADIAN WOMEN SURVIVING BREAST CANCER CONTINUES TO GROW. PRELIMINARY FINDINGS SUGGEST YOGA CAN IMPROVE QUALITY OF LIFE (QOL) IN BREAST CANCER SURVIVORS, BUT FEW STUDIES HAVE FOCUSED ON IYENGAR YOGA (IY). OBJECTIVE: THE PURPOSE OF THIS PILOT STUDY WAS TO EVALUATE THE IMPACT OF IY ON QOL AND PSYCHOSOCIAL FUNCTIONING IN A SELECT SAMPLE OF BREAST CANCER SURVIVORS. METHODS: BREAST CANCER SURVIVORS (N = 24) PARTICIPATING IN IY CLASSES COMPLETED A QUESTIONNAIRE MEASURING GENERIC AND DISEASE-SPECIFIC QOL AND PSYCHOSOCIAL FUNCTIONING, BEFORE AND AFTER THE 12-WEEK CLASSES. RESULTS: POSTPROGRAM QUESTIONNAIRES WERE COMPLETED BY 17 PARTICIPANTS (71%) WHO ATTENDED AN AVERAGE OF 78.9% OF THE IY SESSIONS. SEVERAL INDICATORS OF GENERIC QOL IMPROVED SIGNIFICANTLY, INCLUDING MENTAL HEALTH (MEAN CHANGE, +4.2; P = .045), VITALITY (MEAN CHANGE, +4.9; P = .033), ROLE-EMOTIONAL (MEAN CHANGE, +6.4; P = .010), AND BODILY PAIN (MEAN CHANGE, +4.4; P = .024). OTHER IMPROVEMENTS IN QOL AND PSYCHOSOCIAL FUNCTIONING WERE MEANINGFUL BUT WERE NOT STATISTICALLY SIGNIFICANT. FINDINGS WERE FURTHER SUBSTANTIATED BY PARTICIPANT'S EVALUATION OF THE PROGRAM'S BENEFITS AND MOTIVATIONAL VALUE. CONCLUSION: IN THIS PILOT STUDY OF BREAST CANCER SURVIVORS PARTICIPATING IN IY, WE FOUND IMPROVEMENTS IN QOL AND PSYCHOSOCIAL FUNCTIONING. MOREOVER, POSITIVE PROGRAM EVALUATION AND MOTIVATIONAL PROFILE PROVIDE SUPPORT FOR THE ACCEPTABILITY OF IY WITH BREAST CANCER SURVIVORS. RANDOMIZED CONTROLLED TRIALS COMPARING IY TO USUAL CARE AND OTHER FORMS OF YOGA IN BREAST CANCER SURVIVORS ARE WARRANTED. IMPLICATIONS FOR PRACTICE: NURSES MAY CONSIDER IY AS A POSSIBLE INTERVENTION STRATEGY TO HELP BREAST CANCER SURVIVORS IMPROVE THEIR QOL AND PSYCHOSOCIAL FUNCTIONING.	2010	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       
20 1541  36 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