1 1821 153 PROTOCOL FOR TESTING YOGA TO REDUCE POST-LUMBAR SPINE SURGERY PAIN: A METHODOLOGY ARTICLE. CURRENTLY, ACUTE POSTOPERATIVE PAIN DURING HOSPITALIZATION IS PRIMARILY MANAGED BY MEDICATIONS, AND PATIENTS MUST ADHERE TO RESTRICTIVE POSTOPERATIVE PRECAUTIONS FOR 3 MONTHS FOLLOWING LUMBAR SPINE SURGERIES. YOGA CAN BE AN ALTERNATIVE APPROACH TO ASSIST IN ACUTE AND SUBACUTE POSTOPERATIVE PAIN MANAGEMENT, ANXIETY, AND RETURN TO FUNCTION. THE PURPOSE OF THE PRESENT WORK WAS TO DEVELOP AND TEST THE FEASIBILITY AND EXPLORE THE EFFECTIVENESS OF A TAILORED YOGA PROGRAM, DELIVERED IN-PERSON DURING THE HOSPITAL STAY AND ELECTRONICALLY AFTER HOSPITAL DISCHARGE, AS A POTENTIAL NEW AVENUE FOR POSTOPERATIVE CARE. THIS PILOT STUDY WILL USE A CROSSOVER RANDOMIZED CONTROLLED DESIGN. INDIVIDUALS AGED BETWEEN 40 AND 80 YEARS WHO ARE SCHEDULED FOR LUMBAR LAMINECTOMY AND/OR FUSION, AND WHO HAVE NOT PRACTICED REGULAR YOGA WITHIN THE PAST 6 MONTHS AT THE TIME OF ENROLLMENT, WILL BE RECRUITED AND RANDOMIZED TO EITHER A TAILORED YOGA PROGRAM (INTERVENTION GROUP) OR USUAL CARE (CONTROL GROUP) DURING THE HOSPITAL STAY (PHASE ONE). BEARING IN MIND POSTOPERATIVE PRECAUTIONS, ALL SUBJECTS WILL BE INSTRUCTED TO PERFORM A HOME-BASED TAILORED YOGA PROGRAM DELIVERED ELECTRONICALLY VIA YOUTUBE LINKS FOR 8 WEEKS POST-HOSPITAL DISCHARGE (PHASE TWO). THE PRIMARY OUTCOME MEASURES ASSESSING FEASIBILITY ARE ADHERENCE/COMPLIANCE. SECONDARY OUTCOME MEASURES INCLUDE PAIN, ANXIETY, FUNCTION, SLEEP, PERCEIVED STRESS, AND PAIN-CATASTROPHIZING BEHAVIOR. LENGTH OF HOSPITAL STAY AND PAIN MEDICATION USE, GAIT DISTANCE, AND OVERALL PHYSICAL ACTIVITY DURING HOSPITALIZATION WILL ALSO BE COLLECTED. FINALLY, A QUALITATIVE INTERVIEW WILL BE OBTAINED AFTER COMPLETION OF THE HOSPITAL AND HOME-BASED PROGRAMS. THIS STUDY WILL DETERMINE THE FEASIBILITY OF A TAILORED YOGA PROGRAM FOR ACUTE AND SUBACUTE POSTOPERATIVE LUMBAR SPINE SURGERY PAIN, ANXIETY, AND FUNCTIONAL OUTCOMES.	2021	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 
2  908  44 EFFECTIVENESS OF DEEP CERVICAL FASCIAL MANIPULATION AND YOGA POSTURES ON PAIN, FUNCTION, AND OCULOMOTOR CONTROL IN PATIENTS WITH MECHANICAL NECK PAIN: STUDY PROTOCOL OF A PRAGMATIC, PARALLEL-GROUP, RANDOMIZED, CONTROLLED TRIAL. INTRODUCTION: MECHANICAL NECK PAIN (MNP) IS A COMMONLY OCCURRING MUSCULOSKELETAL CONDITION THAT IS USUALLY MANAGED USING ELECTRICAL MODALITIES, JOINT MOBILIZATION TECHNIQUES, AND THERAPEUTIC EXERCISES, BUT HAS LIMITED EVIDENCE OF THEIR EFFICACY. PATHOLOGY (DENSIFICATION) OF THE DEEP CERVICAL FASCIA THAT OCCURS DUE TO THE INCREASED VISCOSITY OF HYALURONIC ACID (HA) MAY INDUCE NECK PAIN AND ASSOCIATED PAINFUL SYMPTOMS OF THE UPPER QUARTER REGION. FASCIAL MANIPULATION (FM) AND YOGA POSES ARE CONSIDERED TO REDUCE THE THIXOTROPY OF THE GROUND SUBSTANCES OF THE DEEP FASCIA AND IMPROVE MUSCLE FUNCTION. THE PURPOSE OF THIS STUDY IS TO INVESTIGATE THE EFFECT OF FM AND SEQUENTIAL YOGA POSES (SYP) WHEN COMPARED TO THE USUAL CARE ON PAIN, FUNCTION, AND OCULOMOTOR CONTROL IN MNP. METHODS: THIS FACE-MAN TRIAL WILL RECRUIT 160 PATIENTS WITH SUBACUTE AND CHRONIC MECHANICAL NECK PAIN DIAGNOSED USING PREDEFINED CRITERIA. PARTICIPANTS WILL BE RANDOMIZED TO EITHER THE INTERVENTION GROUP OR THE USUAL CARE GROUP, USING A RANDOM ALLOCATION RATIO OF 1:1. PATIENTS IN THE INTERVENTION GROUP WILL RECEIVE FM (4 SESSIONS IN 4 WEEKS) AND SYP (12 WEEKS) WHEREAS THE STANDARD CARE GROUP WILL RECEIVE CERVICAL MOBILIZATION/ THORACIC MANIPULATION (4 SESSIONS IN 4 WEEKS) AND THERAPEUTIC EXERCISES (12 WEEKS). THE PRIMARY OUTCOME IS THE CHANGE IN THE NUMERIC PAIN RATING SCALE (NPRS). THE SECONDARY OUTCOMES INCLUDE CHANGES IN THE PATIENT-SPECIFIC FUNCTIONAL SCALE AND OCULOMOTOR CONTROL, MYOFASCIAL STIFFNESS, FEAR-AVOIDANCE BEHAVIOR QUESTIONNAIRE, AND ELBOW EXTENSION RANGE OF MOTION DURING NEURODYNAMICS TEST 1. DISCUSSION: IF FOUND EFFECTIVE, FM ALONG WITH SYP INVESTIGATED IN THIS TRIAL CAN BE CONSIDERED AS A TREATMENT STRATEGY IN THE MANAGEMENT OF MECHANICAL NECK PAIN. CONSIDERING THE MAGNITUDE OF THE PROBLEM, AND THE PRAGMATIC AND PATIENT-CENTERED APPROACH TO BE FOLLOWED, IT IS WORTH INVESTIGATING THIS TRIAL. TRIAL REGISTRATION: CLINICALTRIALS.GOV CTRI/2020/01/022934 . REGISTERED ON JANUARY 24, 2020 WITH CTRI.NIC.IN. CLINICAL TRIALS REGISTRY - INDIA.	2021	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  
3  507  39 COMPARATIVE EFFECTIVENESS OF PILATES AND YOGA GROUP EXERCISE INTERVENTIONS FOR CHRONIC MECHANICAL NECK PAIN: QUASI-RANDOMISED PARALLEL CONTROLLED STUDY. OBJECTIVES: TO DETERMINE THE EFFECTIVENESS OF PILATES AND YOGA GROUP EXERCISE INTERVENTIONS FOR INDIVIDUALS WITH CHRONIC NECK PAIN (CNP). DESIGN: QUASI-RANDOMISED PARALLEL CONTROLLED STUDY. SETTING: COMMUNITY, UNIVERSITY AND PRIVATE PRACTICE SETTINGS IN FOUR LOCATIONS. PARTICIPANTS: FIFTY-SIX INDIVIDUALS WITH CNP SCORING >/=3/10 ON THE NUMERIC PAIN RATING SCALE FOR >3 MONTHS (CONTROLS N=17, PILATES N=20, YOGA N=19). INTERVENTIONS: EXERCISE PARTICIPANTS COMPLETED 12 SMALL-GROUP SESSIONS WITH MODIFICATIONS AND PROGRESSIONS SUPERVISED BY A PHYSIOTHERAPIST. MAIN OUTCOME MEASURES: THE PRIMARY OUTCOME MEASURE WAS THE NECK DISABILITY INDEX (NDI). SECONDARY OUTCOMES WERE PAIN RATINGS, RANGE OF MOVEMENT AND POSTURAL MEASUREMENTS COLLECTED AT BASELINE, 6 WEEKS AND 12 WEEKS. FOLLOW-UP WAS PERFORMED 6 WEEKS AFTER COMPLETION OF THE EXERCISE CLASSES (WEEK 18). RESULTS: NDI DECREASED SIGNIFICANTLY IN THE PILATES {BASELINE: 11.1 [STANDARD DEVIATION (SD) 4.3] VS WEEK 12: 6.8 (SD 4.3); MEAN DIFFERENCE -4.3 (95% CONFIDENCE INTERVAL -1.64 TO -6.7); P<0.001} AND YOGA GROUPS [BASELINE: 12.8 (SD 7.4) VS WEEK 12: 8.1 (SD 5.6); MEAN DIFFERENCE -4.7 (95% CONFIDENCE INTERVAL -2.1 TO -7.4); P<0.00], WITH NO CHANGE IN THE CONTROL GROUP. PAIN RATINGS ALSO IMPROVED SIGNIFICANTLY. MODERATE-TO-LARGE EFFECT SIZES (0.7 TO 1.8) AND LOW NUMBERS NEEDED TO TREAT WERE FOUND. THERE WERE NO DIFFERENCES IN OUTCOMES BETWEEN THE EXERCISE GROUPS OR ASSOCIATED ADVERSE EFFECTS. NO IMPROVEMENTS IN RANGE OF MOVEMENT OR POSTURE WERE FOUND. CONCLUSIONS: PILATES AND YOGA GROUP EXERCISE INTERVENTIONS WITH APPROPRIATE MODIFICATIONS AND SUPERVISION WERE SAFE AND EQUALLY EFFECTIVE FOR DECREASING DISABILITY AND PAIN COMPARED WITH THE CONTROL GROUP FOR INDIVIDUALS WITH MILD-TO-MODERATE CNP. PHYSIOTHERAPISTS MAY CONSIDER INCLUDING THESE APPROACHES IN A PLAN OF CARE. CLINICAL TRIAL REGISTRATION NUMBER: CLINICALTRIALS.GOV NCT01999283.	2016	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          
4  258  46 ACCEPTABILITY AND FEASIBILITY OF A 12-WEEK YOGA VS. EDUCATIONAL FILM PROGRAM FOR THE MANAGEMENT OF RESTLESS LEGS SYNDROME (RLS): STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: RESTLESS LEGS SYNDROME (RLS) IS A COMMON AND BURDENSOME SLEEP DISORDER ASSOCIATED WITH PROFOUND IMPAIRMENT OF HEALTH, WELL-BEING, AND QUALITY OF LIFE. UNFORTUNATELY, THE MEDICATIONS USED FOR RLS MANAGEMENT CARRY RISK OF SERIOUS SIDE EFFECTS, INCLUDING AUGMENTATION OF SYMPTOMS. YOGA, AN ANCIENT MIND-BODY DISCIPLINE DESIGNED TO PROMOTE PHYSICAL, EMOTIONAL, AND MENTAL WELL-BEING, MAY OFFER A VIABLE, LOW-RISK NEW TREATMENT. THE PRIMARY OBJECTIVES OF THIS PILOT, PARALLEL-ARM, RANDOMIZED CONTROLLED TRIAL (RCT) ARE TO ASSESS THE ACCEPTABILITY AND FEASIBILITY OF A 12-WEEK YOGA VS. EDUCATIONAL FILM PROGRAM FOR THE MANAGEMENT OF RLS. METHODS: FORTY-FOUR ADULTS WITH CONFIRMED MODERATE TO SEVERE RLS WILL BE RECRUITED AND RANDOMIZED TO A 12-WEEK YOGA (N = 22) OR STANDARDIZED EDUCATIONAL FILM PROGRAM (N = 22). YOGA GROUP PARTICIPANTS WILL ATTEND TWO 75-MIN IYENGAR YOGA CLASSES PER WEEK FOR THE FIRST 4 WEEKS, THEN ONE 75-MIN CLASS PER WEEK FOR THE REMAINING 8 WEEKS, AND WILL COMPLETE A 30-MIN HOMEWORK ROUTINE ON NON-CLASS DAYS. EDUCATIONAL FILM GROUP PARTICIPANTS WILL ATTEND ONE 75-MIN CLASS PER WEEK FOR 12 WEEKS AND COMPLETE A DAILY RLS TREATMENT LOG; CLASSES WILL INCLUDE INFORMATION ON: RLS MANAGEMENT, INCLUDING SLEEP HYGIENE PRACTICES; OTHER SLEEP DISORDERS; AND COMPLEMENTARY THERAPIES LIKELY TO BE OF INTEREST TO THOSE PARTICIPATING IN A YOGA AND SLEEP EDUCATION STUDY. YOGA AND TREATMENT LOGS WILL BE COLLECTED WEEKLY. FEASIBILITY OUTCOMES WILL INCLUDE RECRUITMENT, ENROLLMENT, AND RANDOMIZATION RATES, RETENTION, ADHERENCE, AND PROGRAM SATISFACTION. PROGRAM EVALUATION AND YOGA-DOSING QUESTIONNAIRES WILL BE COLLECTED AT WEEK 12; DATA ON EXPLORATORY OUTCOMES (E.G., RLS SYMPTOM SEVERITY (IRLS), SLEEP QUALITY (PSQI), MOOD (POMS, PSS), AND HEALTH-RELATED QUALITY OF LIFE (SF-36)) WILL BE GATHERED AT BASELINE AND WEEK 12. DISCUSSION: THIS STUDY WILL LAY THE ESSENTIAL GROUNDWORK FOR A PLANNED LARGER RCT TO DETERMINE THE EFFICACY OF A YOGA PROGRAM FOR REDUCING SYMPTOMS AND ASSOCIATED BURDEN OF RLS. IF THE FINDINGS OF THE CURRENT TRIAL AND THE SUBSEQUENT LARGER RCTS ARE POSITIVE, THIS STUDY WILL ALSO HELP SUPPORT A NEW APPROACH TO CLINICAL TREATMENT OF THIS CHALLENGING DISORDER, HELP FOSTER IMPROVED UNDERSTANDING OF RLS ETIOLOGY, AND ULTIMATELY CONTRIBUTE TO REDUCING THE INDIVIDUAL, SOCIETAL, AND ECONOMIC BURDEN ASSOCIATED WITH THIS CONDITION. TRIAL REGISTRATION: CLINICALTRIALS.GOV, ID: NCT03570515 . RETROSPECTIVELY REGISTERED ON 1 FEBRUARY 2017.	2019	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    
5 2843  36 YOGA, COGNITIVE-BEHAVIOURAL THERAPY VERSUS EDUCATION TO IMPROVE QUALITY OF LIFE AND REDUCE HEALTHCARE COSTS IN PEOPLE WITH ENDOMETRIOSIS: A RANDOMISED CONTROLLED TRIAL. INTRODUCTION: ENDOMETRIOSIS IS A DEBILITATING CHRONIC INFLAMMATORY CONDITION HIGHLY BURDENSOME TO THE HEALTHCARE SYSTEM. THE PRESENT TRIAL WILL ESTABLISH THE EFFICACY OF (1) YOGA AND (2) COGNITIVE-BEHAVIOURAL THERAPY (CBT), ABOVE (3) EDUCATION, ON QUALITY OF LIFE, BIOPSYCHOSOCIAL OUTCOMES AND COST-EFFECTIVENESS. METHODS AND ANALYSIS: THIS STUDY IS A PARALLEL RANDOMISED CONTROLLED TRIAL. PARTICIPANTS WILL BE RANDOMLY ALLOCATED TO YOGA, CBT OR EDUCATION. PARTICIPANTS WILL BE ENGLISH-SPEAKING ADULTS, HAVE A DIAGNOSIS OF ENDOMETRIOSIS BY A QUALIFIED PHYSICIAN, WITH PAIN FOR AT LEAST 6 MONTHS, AND ACCESS TO INTERNET. PARTICIPANTS WILL ATTEND 8 WEEKLY GROUP CBT SESSIONS OF 120 MIN; OR 8 WEEKLY GROUP YOGA SESSIONS OF 60 MIN; OR RECEIVE WEEKLY EDUCATIONAL HANDOUTS ON ENDOMETRIOSIS. THE PRIMARY OUTCOME MEASURE IS QUALITY OF LIFE. THE ANALYSIS WILL INCLUDE MIXED-EFFECTS ANALYSIS OF VARIANCE AND LINEAR MODELS, COST-UTILITY ANALYSIS FROM A SOCIETAL AND HEALTH SYSTEM PERSPECTIVE AND QUALITATIVE THEMATIC ANALYSIS. ETHICS AND DISSEMINATION: ENROLMENT IN THE STUDY IS VOLUNTARY AND PARTICIPANTS CAN WITHDRAW AT ANY TIME. PARTICIPANTS WILL BE GIVEN THE OPTION TO DISCUSS THE STUDY WITH THEIR NEXT OF KIN/TREATING PHYSICIAN. FINDINGS WILL BE DISSEMINATED VIA PUBLICATIONS, CONFERENCES AND BRIEFS TO PROFESSIONAL ORGANISATIONS. THE UNIVERSITY'S MEDIA TEAM WILL ALSO BE USED TO FURTHER DISSEMINATE VIA LAY PERSON ARTICLES AND MEDIA RELEASES. TRIAL REGISTRATION NUMBER: ACTRN12620000756921P; PRE-RESULTS.	2021	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 
6 2638  43 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        
7 1870  31 RANDOMIZED-CONTROLLED TRIAL COMPARING YOGA AND HOME-BASED EXERCISE FOR CHRONIC NECK PAIN. OBJECTIVES: CHRONIC NECK PAIN IS A SIGNIFICANT PUBLIC HEALTH PROBLEM WITH ONLY VERY FEW EVIDENCE-BASED TREATMENT OPTIONS. THERE IS GROWING EVIDENCE FOR THE EFFECTIVENESS OF YOGA FOR RELIEVING MUSCULOSKELETAL DISORDERS. THE AIM OF THIS STUDY WAS TO EVALUATE THE EFFECT OF IYENGAR YOGA COMPARED WITH EXERCISE ON CHRONIC NONSPECIFIC NECK PAIN. METHODS: PATIENTS WERE RANDOMLY ASSIGNED TO EITHER YOGA OR EXERCISE. THE YOGA GROUP ATTENDED A 9-WEEK YOGA COURSE AND THE EXERCISE GROUP RECEIVED A SELF-CARE MANUAL ON HOME-BASED EXERCISES FOR NECK PAIN RELIEF. THE MAIN OUTCOME MEASURE WAS THE PRESENT NECK PAIN INTENSITY (100 MM VISUAL ANALOG SCALE). SECONDARY OUTCOME MEASURES INCLUDED FUNCTIONAL DISABILITY (NECK DISABILITY INDEX), PAIN AT MOTION (VISUAL ANALOG SCALE), HEALTH-RELATED QUALITY OF LIFE (SHORT FORM-36 QUESTIONNAIRE), CERVICAL RANGE OF MOTION, PROPRIOCEPTIVE ACUITY, AND PRESSURE PAIN THRESHOLD. RESULTS: FIFTY-ONE PATIENTS (MEAN AGE 47.8 Y ; 82.4% FEMALE) WERE RANDOMIZED TO YOGA (N=25) AND EXERCISE (N=26) INTERVENTION. AFTER THE STUDY PERIOD, PATIENTS IN THE YOGA GROUP REPORTED SIGNIFICANTLY LESS NECK PAIN INTENSITY COMPARED WITH THE EXERCISE GROUP [MEAN DIFFERENCE: -13.9 MM (95% CI, -26.4 TO -1.4), P=0.03]. THE YOGA GROUP REPORTED LESS DISABILITY AND BETTER MENTAL QUALITY OF LIFE. RANGE OF MOTION AND PROPRIOCEPTIVE ACUITY WERE IMPROVED AND THE PRESSURE PAIN THRESHOLD WAS ELEVATED IN THE YOGA GROUP. DISCUSSION: YOGA WAS MORE EFFECTIVE IN RELIEVING CHRONIC NONSPECIFIC NECK PAIN THAN A HOME-BASED EXERCISE PROGRAM. YOGA REDUCED NECK PAIN INTENSITY AND DISABILITY AND IMPROVED HEALTH-RELATED QUALITY OF LIFE. MOREOVER, YOGA SEEMS TO INFLUENCE THE FUNCTIONAL STATUS OF NECK MUSCLES, AS INDICATED BY IMPROVEMENT OF PHYSIOLOGICAL MEASURES OF NECK PAIN.	2013	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     
8 2831  39 YOGA VS. PHYSICAL THERAPY VS. EDUCATION FOR CHRONIC LOW BACK PAIN IN PREDOMINANTLY MINORITY POPULATIONS: STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL. BACKGROUND: CHRONIC LOW BACK PAIN CAUSES SUBSTANTIAL MORBIDITY AND COST TO SOCIETY WHILE DISPROPORTIONATELY IMPACTING LOW-INCOME AND MINORITY ADULTS. SEVERAL RANDOMIZED CONTROLLED TRIALS SHOW YOGA IS AN EFFECTIVE TREATMENT. HOWEVER, THE COMPARATIVE EFFECTIVENESS OF YOGA AND PHYSICAL THERAPY, A COMMON MAINSTREAM TREATMENT FOR CHRONIC LOW BACK PAIN, IS UNKNOWN. METHODS/DESIGN: THIS IS A RANDOMIZED CONTROLLED TRIAL FOR 320 PREDOMINANTLY LOW-INCOME MINORITY ADULTS WITH CHRONIC LOW BACK PAIN, COMPARING YOGA, PHYSICAL THERAPY, AND EDUCATION. INCLUSION CRITERIA ARE ADULTS 18-64 YEARS OLD WITH NON-SPECIFIC LOW BACK PAIN LASTING >/= 12 WEEKS AND A SELF-REPORTED AVERAGE PAIN INTENSITY OF >/= 4 ON A 0-10 SCALE. RECRUITMENT TAKES PLACE AT BOSTON MEDICAL CENTER, AN URBAN ACADEMIC SAFETY-NET HOSPITAL AND SEVEN FEDERALLY QUALIFIED COMMUNITY HEALTH CENTERS LOCATED IN DIVERSE NEIGHBORHOODS. THE 52-WEEK STUDY HAS AN INITIAL 12-WEEK TREATMENT PHASE WHERE PARTICIPANTS ARE RANDOMIZED IN A 2:2:1 RATIO INTO I) A STANDARDIZED WEEKLY HATHA YOGA CLASS SUPPLEMENTED BY HOME PRACTICE; II) A STANDARDIZED EVIDENCE-BASED EXERCISE THERAPY PROTOCOL ADAPTED FROM THE TREATMENT BASED CLASSIFICATION METHOD, INDIVIDUALLY DELIVERED BY A PHYSICAL THERAPIST AND SUPPLEMENTED BY HOME PRACTICE; AND III) EDUCATION DELIVERED THROUGH A SELF-CARE BOOK. CO-PRIMARY OUTCOME MEASURES ARE 12-WEEK PAIN INTENSITY MEASURED ON AN 11-POINT NUMERICAL RATING SCALE AND BACK-SPECIFIC FUNCTION MEASURED USING THE MODIFIED ROLAND MORRIS DISABILITY QUESTIONNAIRE. IN THE SUBSEQUENT 40-WEEK MAINTENANCE PHASE, YOGA PARTICIPANTS ARE RE-RANDOMIZED IN A 1:1 RATIO TO EITHER STRUCTURED MAINTENANCE YOGA CLASSES OR HOME PRACTICE ONLY. PHYSICAL THERAPY PARTICIPANTS ARE SIMILARLY RE-RANDOMIZED TO EITHER FIVE BOOSTER SESSIONS OR HOME PRACTICE ONLY. EDUCATION PARTICIPANTS CONTINUE TO FOLLOW RECOMMENDATIONS OF EDUCATIONAL MATERIALS. WE WILL ALSO ASSESS COST EFFECTIVENESS FROM THE PERSPECTIVES OF THE INDIVIDUAL, INSURERS, AND SOCIETY USING CLAIMS DATABASES, ELECTRONIC MEDICAL RECORDS, SELF-REPORT COST DATA, AND STUDY RECORDS. QUALITATIVE DATA FROM INTERVIEWS WILL ADD SUBJECTIVE DETAIL TO COMPLEMENT QUANTITATIVE DATA. TRIAL REGISTRATION: THIS TRIAL IS REGISTERED IN CLINICALTRIALS.GOV, WITH THE ID NUMBER: NCT01343927.	2014	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        
9  536  44 COMPARISON OF YOGA VERSUS STRETCHING FOR CHRONIC LOW BACK PAIN: PROTOCOL FOR THE YOGA EXERCISE SELF-CARE (YES) TRIAL. BACKGROUND: BACK PAIN, ONE OF THE MOST PREVALENT CONDITIONS AFFLICTING AMERICAN ADULTS, IS THE LEADING REASON FOR USING COMPLEMENTARY AND ALTERNATIVE MEDICINE (CAM) THERAPIES. YOGA IS AN INCREASINGLY POPULAR "MIND-BODY" CAM THERAPY OFTEN USED FOR RELIEVING BACK PAIN AND SEVERAL SMALL STUDIES HAVE FOUND YOGA EFFECTIVE FOR THIS CONDITION. THIS STUDY WILL ASSESS WHETHER YOGA IS EFFECTIVE FOR TREATING CHRONIC LOW BACK PAIN COMPARED WITH SELF CARE AND EXERCISE AND WILL EXPLORE THE MECHANISMS RESPONSIBLE FOR ANY OBSERVED BENEFITS. METHODS/DESIGN: A TOTAL OF 210 PARTICIPANTS WITH LOW BACK PAIN LASTING AT LEAST 3 MONTHS WILL BE RECRUITED FROM PRIMARY CARE CLINICS OF A LARGE HEALTHCARE SYSTEM BASED IN SEATTLE. THEY WILL BE RANDOMIZED IN A 2:2:1 RATIO TO RECEIVE 12 WEEKLY YOGA CLASSES, 12 WEEKLY CONVENTIONAL THERAPEUTIC EXERCISE CLASSES OF COMPARABLE PHYSICAL EXERTION, OR A SELF-CARE BOOK. INTERVIEWERS MASKED TO PARTICIPANTS' TREATMENT GROUP WILL ASSESS OUTCOMES AT BASELINE AND 6, 12 AND 26 WEEKS AFTER RANDOMIZATION. PRIMARY OUTCOMES WILL BE BACK-RELATED DYSFUNCTION AND SYMPTOM BOTHERSOMENESS. IN ADDITION, DATA WILL BE COLLECTED ON PHYSICAL MEASUREMENTS (E.G., FLEXION) AT BASELINE AND 12 WEEKS AND SALIVA SAMPLES WILL BE OBTAINED AT BASELINE, 6 AND 12 WEEKS. INFORMATION WILL BE COLLECTED ON SPECIFIC PHYSICAL, PSYCHOLOGICAL, AND PHYSIOLOGICAL FACTORS TO ALLOW EXPLORATION OF POSSIBLE MECHANISMS OF ACTION THROUGH WHICH YOGA COULD RELIEVE BACK PAIN AND DYSFUNCTION. THE EFFECTIVENESS OF YOGA WILL BE ASSESSED USING ANALYSIS OF COVARIANCE (USING GENERAL ESTIMATING EQUATIONS - GEE) WITHIN AN INTENTION-TO-TREAT CONTEXT. IF YOGA IS FOUND EFFECTIVE, FURTHER ANALYSES WILL EXPLORE WHETHER YOGA'S BENEFITS ARE ATTRIBUTABLE TO PHYSICAL, PSYCHOLOGICAL AND/OR PHYSIOLOGICAL FACTORS. CONCLUSIONS: THIS STUDY WILL PROVIDE THE CLEAREST EVIDENCE TO DATE ABOUT THE VALUE OF YOGA AS A THERAPEUTIC OPTION FOR TREATING CHRONIC BACK PAIN, AND IF THE RESULTS ARE POSITIVE, WILL HELP FOCUS FUTURE, MORE IN-DEPTH, RESEARCH ON THE MOST PROMISING POTENTIAL MECHANISMS OF ACTION IDENTIFIED BY THIS STUDY.	2010	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     
10 2577  41 YOGA FOR GENERALIZED ANXIETY DISORDER: DESIGN OF A RANDOMIZED CONTROLLED CLINICAL TRIAL. GENERALIZED ANXIETY DISORDER (GAD) IS A COMMON DISORDER ASSOCIATED WITH SIGNIFICANT DISTRESS AND INTERFERENCE. ALTHOUGH COGNITIVE BEHAVIORAL THERAPY (CBT) HAS BEEN SHOWN TO BE THE MOST EFFECTIVE FORM OF PSYCHOTHERAPY, FEW PATIENTS RECEIVE OR HAVE ACCESS TO THIS INTERVENTION. YOGA THERAPY OFFERS ANOTHER PROMISING, YET UNDER-RESEARCHED, INTERVENTION THAT IS GAINING INCREASING POPULARITY IN THE GENERAL PUBLIC, AS AN ANXIETY REDUCTION INTERVENTION. THE PURPOSE OF THIS INNOVATIVE CLINICAL TRIAL PROTOCOL IS TO INVESTIGATE THE EFFICACY OF A KUNDALINI YOGA INTERVENTION, RELATIVE TO CBT AND A CONTROL CONDITION. KUNDALINI YOGA AND CBT ARE COMPARED WITH EACH OTHER IN A NONINFERIORITY TEST AND BOTH TREATMENTS ARE COMPARED TO STRESS EDUCATION TRAINING, AN ATTENTION CONTROL INTERVENTION, IN SUPERIORITY TESTS. THE SAMPLE WILL CONSIST OF 230 INDIVIDUALS WITH A PRIMARY DSM-5 DIAGNOSIS OF GAD. THIS RANDOMIZED CONTROLLED TRIAL WILL COMPARE YOGA (N=95) TO BOTH CBT FOR GAD (N=95) AND STRESS EDUCATION (N=40), A COMMONLY USED CONTROL CONDITION. ALL THREE TREATMENTS WILL BE ADMINISTERED BY TWO INSTRUCTORS IN A GROUP FORMAT OVER 12 WEEKLY SESSIONS WITH FOUR TO SIX PATIENTS PER GROUP. GROUPS WILL BE RANDOMIZED USING PERMUTED BLOCK RANDOMIZATION, WHICH WILL BE STRATIFIED BY SITE. TREATMENT OUTCOME WILL BE EVALUATED BI-WEEKLY AND AT 6MONTH FOLLOW-UP. FURTHERMORE, POTENTIAL MEDIATORS OF TREATMENT OUTCOME WILL BE INVESTIGATED. GIVEN THE INDIVIDUAL AND ECONOMIC BURDEN ASSOCIATED WITH GAD, IDENTIFYING ACCESSIBLE ALTERNATIVE BEHAVIORAL TREATMENTS WILL HAVE SUBSTANTIVE PUBLIC HEALTH IMPLICATIONS.	2015	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      
11 2441  33 YOGA AND SCHIZOPHRENIA-A COMPREHENSIVE ASSESSMENT OF NEUROPLASTICITY: PROTOCOL FOR A SINGLE BLIND RANDOMIZED CONTROLLED STUDY OF YOGA IN SCHIZOPHRENIA. INTRODUCTION: SCHIZOPHRENIA IS ONE OF THE MOST SEVERE MENTAL DISORDERS WITH A PREVALENCE OF ABOUT 1% AND A LEADING CAUSE OF DISABILITY AMONG YOUNG ADULTS. PHARMACOTHERAPY IS THE MAINSTAY IN THE MANAGEMENT OF SCHIZOPHRENIA. HOWEVER, EVEN WITH THE BEST OF MEDICATION, SEVERAL PROBLEMS LIKE REFRACTORINESS, NEGATIVE SYMPTOMS, FREQUENT RELAPSES, AND COGNITIVE IMPAIRMENTS PERSIST. METHODS: THIS IS A RANDOMIZED-CONTROLLED CLINICAL STUDY INCLUDING PATIENTS FROM AN URBAN TERTIARY HOSPITAL AND A SEMI-URBAN COMMUNITY CENTER, WITH A BETWEEN-GROUP, REPEATED-MEASURES, LONGITUDINAL DESIGN. THIS STUDY WILL RECRUIT 160 PATIENTS WITH DSM 5 DIAGNOSIS OF SCHIZOPHRENIA WHO ARE ON STABLE MEDICATION FOR A MINIMUM OF 6 WEEKS; THEY WILL BE RANDOMLY ASSIGNED INTO 2 ARMS VIZ., YOGA THERAPY (YT), AND TREATMENT-AS-USUAL (TAU) WITH 80 PATIENTS IN EACH ARM. PARTICIPANTS WILL UNDERGO CLINICAL, LABORATORY, AND RADIOLOGICAL ASSESSMENTS AT BASELINE AND AT INTERVALS OF 1 MONTH, 3 MONTHS, AND 6 MONTHS FROM THE BASELINE. IT IS HYPOTHESIZED THAT YOGA WILL IMPROVE PSYCHOPATHOLOGY AND EMOTION PROCESSING, INCREASE SERUM BRAIN DERIVED NEUROTROPHIC FACTOR (BDNF) AND PLASMA OXYTOCIN LEVELS AND EFFECT CHANGES IN CEREBRAL ACTIVATION IN AREAS OF THE BRAIN ASSOCIATED WITH SCHIZOPHRENIA. DISCUSSION: THIS STUDY AIMS TO MEASURE THE EFFICACY OF A YOGA-BASED INTERVENTION AS AN ADJUNCT IN PATIENTS WITH SCHIZOPHRENIA AS WELL AS THE MECHANISMS OF THESE EFFECTS. TRIAL REGISTRATION: REGISTERED RETROSPECTIVELY WITH CLINICAL TRIAL REGISTRY - INDIA (CTRI) WITH REGISTRATION NUMBER CTRI/2017/08/009219.	2019	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                
12  181  41 A RANDOMIZED CONTROLLED TRIAL OF YOGA VS NONAEROBIC EXERCISE FOR VETERANS WITH PTSD: UNDERSTANDING EFFICACY, MECHANISMS OF CHANGE, AND MODE OF DELIVERY. BACKGROUND AND OBJECTIVES: POSTTRAUMATIC STRESS DISORDER (PTSD) IS A CHRONIC, DISABLING, AND PREVALENT MENTAL HEALTH DISORDER AMONG VETERANS. DESPITE THE AVAILABILITY OF EMPIRICALLY SUPPORTED PSYCHOTHERAPIES, MANY VETERANS REMAIN SYMPTOMATIC AFTER TREATMENT AND/OR PREFER TO SEEK COMPLEMENTARY AND INTEGRATIVE HEALTH APPROACHES, INCLUDING YOGA, TO MANAGE PTSD. THE RANDOMIZED CONTROLLED TRIAL (RCT) DESCRIBED HEREIN WILL EVALUATE THE EFFICACY OF A MANUALIZED YOGA PROGRAM AS COMPARED TO NONAEROBIC EXERCISE IN REDUCING PTSD SEVERITY AMONG VETERANS. A SECONDARY AIM OF THIS STUDY IS TO BETTER UNDERSTAND THE MECHANISMS OF CHANGE. METHODS: VETERANS (N = 192) WITH PTSD WILL BE RANDOMIZED TO HATHA YOGA OR NONAEROBIC PHYSICAL ACTIVITY CONTROL; BOTH GROUPS CONSIST OF 12 WEEKLY, 60-MIN GROUP OR ONLINE TRAINING SESSIONS WITH 15-20 MIN OF DAILY AT-HOME PRACTICE. OUTCOME MEASURES WILL BE ADMINISTERED AT BASELINE, MID-TREATMENT, POSTTREATMENT, AND 12-WEEK FOLLOW-UP. PROJECTED OUTCOMES: THIS STUDY WILL EVALUATE CHANGES IN PTSD SEVERITY (PRIMARY OUTCOME) AS WELL AS DEPRESSION, ANXIETY, ANGER, SLEEP PROBLEMS, AND PSYCHOSOCIAL DISABILITY (SECONDARY OUTCOMES). WE WILL ALSO USE MULTIPLE MEDIATION TO EXAMINE TWO POTENTIAL MODELS OF THE MECHANISMS OF CLINICAL EFFECT: THE ATTENTION MODEL (I.E., YOGA INCREASES ATTENTIONAL CONTROL, WHICH REDUCES PTSD SYMPTOMS), THE COPING MODEL (I.E., YOGA INCREASES DISTRESS TOLERANCE, WHICH IMPROVES COPING, WHICH REDUCES PTSD SYMPTOMS), AND THE COMBINATION OF THESE MODELS. THIS ASPECT OF THE STUDY IS INNOVATIVE AND IMPORTANT GIVEN THE ABSENCE OF AN EXISTING, COMPREHENSIVE MODEL FOR UNDERSTANDING YOGA'S IMPACT ON PTSD. ULTIMATELY, WE HOPE TO DEVELOP GUIDELINES FOR APPLICATION OF YOGA TO PTSD RECOVERY.	2021	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     
13  199  45 A RESEARCH PROTOCOL FOR A PILOT, RANDOMIZED CONTROLLED TRIAL DESIGNED TO EXAMINE THE FEASIBILITY OF A DYADIC VERSUS INDIVIDUAL YOGA PROGRAM FOR FAMILY CAREGIVERS OF GLIOMA PATIENTS UNDERGOING RADIOTHERAPY. BACKGROUND: ALTHOUGH THE DIAGNOSIS AND TREATMENT OF A PRIMARY BRAIN TUMOR PRESENT UNIQUE CHALLENGES TO PATIENTS AND THEIR FAMILY CAREGIVERS, EVIDENCE-BASED SUPPORTIVE CARE INTERVENTIONS ARE GENERALLY LACKING. THE PRIMARY AIM OF THIS RESEARCH PROTOCOL IS TO DETERMINE THE FEASIBILITY OF IMPLEMENTING A DYADIC YOGA (DY) VERSUS A CAREGIVER YOGA (CY) INTERVENTION OR A WAIT-LIST CONTROL (WLC) GROUP USING A RANDOMIZED CONTROLLED TRIAL DESIGN. METHODS: SEVENTY-FIVE GLIOMA PATIENTS UNDERGOING RADIOTHERAPY AND THEIR FAMILY CAREGIVERS ARE RANDOMIZED TO THE DY, CY, OR A WLC GROUP. PATIENT-CAREGIVER DYADS IN THE DY GROUP AND CAREGIVERS IN THE CY GROUP RECEIVE 15 SESSIONS (45 MIN EACH) OVER THE COURSE OF PATIENTS' STANDARD RADIOTHERAPY (6 WEEKS). PATIENTS AND CAREGIVERS IN ALL GROUPS COMPLETE BASELINE ASSESSMENTS OF SYMPTOMS, QUALITY OF LIFE (QOL), AND HEALTH UTILIZATION OUTCOMES PRIOR TO RANDOMIZATION. FOLLOW-UP ASSESSMENTS ARE PERFORMED 6 WEEKS AND THEN AGAIN 3 MONTHS LATER. THE PRIMARY OUTCOME IS FEASIBILITY (I.E., >/= 50% OF ELIGIBLE DYADS CONSENT, >/= 70% OF ENROLLED DYADS COMPLETE ALL ASSESSMENTS, AND >/= 50% OF ALL PRACTICE SESSIONS ARE ATTENDED). WE WILL ALSO PERFORM PRIMARILY DESCRIPTIVE ANALYSES OF THE SELF-REPORTED OUTCOMES (E.G., FATIGUE, OVERALL QOL) AND EXPLORE POTENTIAL INTERVENTION MODERATORS (E.G., PERFORMANCE STATUS) TO INFORM A LARGER FUTURE TRIAL. CONCLUSION: THIS TRIAL WILL PROVIDE IMPORTANT INFORMATION REGARDING THE FEASIBILITY OF A DYADIC VERSUS A CAREGIVER YOGA INTERVENTION REGARDING SYMPTOM, QOL, AND HEALTH UTILIZATION OUTCOMES IN GLIOMA PATIENTS AND THEIR CAREGIVERS. TRIAL REGISTRATION: CLINICALTRIALS.GOV NCT02481349.	2019	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              
14 2824  45 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	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 
15 2008  43 STUDY PROTOCOL FOR YOGA-BASED LIFESTYLE INTERVENTION FOR HEALTHY AGEING PHENOTYPE IN THE OLDER ADULTS (YHAP): A TWO-ARMED, WAITLIST RANDOMISED CONTROLLED TRIAL WITH MULTIPLE PRIMARY OUTCOMES. INTRODUCTION: THE CONCEPTUALISATION OF HEALTHY AGEING PHENOTYPE (HAP) AND THE AVAILABILITY OF A TENTATIVE PANEL FOR HAP BIOMARKERS RAISE THE NEED TO TEST THE EFFICACY OF POTENTIAL INTERVENTIONS TO PROMOTE HEALTH IN OLDER ADULTS. THIS STUDY PROTOCOL REPORTS THE METHODOLOGY FOR A 24-WEEK PROGRAMME TO EXPLORE THE HOLISTIC INFLUENCE OF THE YOGA-BASED INTERVENTION ON THE (BIO)MARKERS OF HAP. METHODS AND ANALYSIS: THE STUDY IS A TWO-ARMED, RANDOMISED WAITLIST CONTROLLED TRIAL WITH BLINDED OUTCOME ASSESSORS AND MULTIPLE PRIMARY OUTCOMES. WE AIM TO RECRUIT 250 SUBJECTS, AGED 60-80 YEARS FROM THE RESIDENTIAL COMMUNITIES AND OLD AGE CLUBS IN BANGALORE CITY, INDIA, WHO WILL UNDERGO RANDOMISATION INTO INTERVENTION OR CONTROL ARMS (1:1). THE INTERVENTION WILL INCLUDE A YOGA-BASED PROGRAMME TAILORED FOR THE OLDER ADULTS, 1 HOUR PER DAY FOR 6 DAYS A WEEK, SPREAD FOR 24 WEEKS. DATA WOULD BE COLLECTED AT THE BASELINE AND POST-INTERVENTION, THE 24TH WEEK. THE MULTIPLE PRIMARY OUTCOMES OF THE STUDY ARE THE (BIO)MARKERS OF HAP: GLYCATED HAEMOGLOBIN, LOW-DENSITY LIPOPROTEIN CHOLESTEROL (LDL-C), SYSTOLIC BLOOD PRESSURE, AND FORCED EXPIRATORY VOLUME IN 1 S FOR PHYSIOLOGICAL AND METABOLIC HEALTH; DIGIT SYMBOL SUBSTITUTION TEST, TRAIL MAKING TESTS A AND B FOR COGNITION; HAND GRIP STRENGTH AND GAIT SPEED FOR PHYSICAL CAPABILITY; LONELINESS FOR SOCIAL WELL-BEING AND WHO QUALITY OF LIFE INSTRUMENT-SHORT FORM FOR QUALITY OF LIFE. THE SECONDARY OUTCOMES INCLUDE INFLAMMATORY MARKERS, TUMOUR NECROSIS FACTOR-ALPHA RECEPTOR II, C REACTIVE PROTEIN, INTERLEUKIN 6 AND SERUM KLOTHO LEVELS. ANALYSES WILL BE BY INTENTION-TO-TREAT AND THE HOLISTIC IMPACT OF YOGA ON HAP WILL BE ASSESSED USING GLOBAL STATISTICAL TEST. ETHICS AND DISSEMINATION: THE STUDY IS APPROVED BY THE INSTITUTIONAL ETHICS COMMITTEE OF SWAMI VIVEKANANDA YOGA ANUSANDHANA SAMSTHANA UNIVERSITY, BANGALORE (ID: RES/IEC-SVYASA/143/2019). WRITTEN INFORMED CONSENT WILL BE OBTAINED FROM EACH PARTICIPANT PRIOR TO INCLUSION. RESULTS WILL BE AVAILABLE THROUGH RESEARCH ARTICLES AND CONFERENCES. TRIAL REGISTRATION NUMBER: CTRI/2021/02/031373.	2021	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        
16 2035  28 TELE-YOGA FOR CHRONIC PAIN: CURRENT STATUS AND FUTURE DIRECTIONS. PAIN IS A PERVASIVE, DEBILITATING DISORDER THAT IS RESISTANT TO LONG-TERM PHARMACOLOGICAL INTERVENTIONS. ALTHOUGH PSYCHOLOGICAL THERAPIES SUCH AS COGNITIVE BEHAVIOR THERAPY DEMONSTRATE MODERATE EFFICACY, MANY INDIVIDUALS CONTINUE TO HAVE ONGOING DIFFICULTIES FOLLOWING TREATMENT. THERE IS A CURRENT TREND TO ESTABLISH COMPLEMENTARY AND INTEGRATIVE HEALTH INTERVENTIONS FOR CHRONIC PAIN, FOR WHICH YOGA HAS BEEN FOUND TO HAVE EXCITING POTENTIAL. NEVERTHELESS, AN IMPORTANT CONSIDERATION WITHIN THE FIELD IS ACCESSIBILITY TO ADEQUATE CARE. TELEHEALTH CAN BE USED TO PROVIDE REAL-TIME INTERACTIVE VIDEO CONFERENCING LEADING TO INCREASED ACCESS TO HEALTH CARE FOR INDIVIDUALS LOCATED REMOTELY OR WHO OTHERWISE HAVE DIFFICULTY ACCESSING SERVICES, PERHAPS THROUGH ISSUES OF MOBILITY OR PROXIMITY OF ADEQUATE SERVICES. THIS ARTICLE ASSESSES THE CURRENT STATUS AND FEASIBILITY OF IMPLEMENTING TELE-YOGA FOR CHRONIC PAIN. METHODOLOGICAL LIMITATIONS AND RECOMMENDATIONS FOR FUTURE RESEARCH ARE DISCUSSED.	2018	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                
17 1291  32 GROUP ACUPUNCTURE THERAPY WITH YOGA THERAPY FOR CHRONIC NECK, LOW BACK, AND OSTEOARTHRITIS PAIN IN SAFETY NET SETTING FOR AN UNDERSERVED POPULATION: DESIGN AND RATIONALE FOR A FEASIBILITY PILOT. CHRONIC PAIN IS PREVALENT IN THE UNITED STATES, WITH IMPACT ON PHYSICAL AND PSYCHOLOGICAL FUNCTIONING AS WELL AS LOST WORK PRODUCTIVITY. MINORITY AND LOWER SOCIOECONOMIC POPULATIONS HAVE INCREASED PREVALENCE OF CHRONIC PAIN WITH LESS ACCESS TO PAIN CARE, POORER OUTCOMES, AND HIGHER RISK OF FATAL OPIOID OVERDOSE. ACUPUNCTURE THERAPY IS EFFECTIVE IN TREATING CHRONIC PAIN CONDITIONS INCLUDING CHRONIC LOW BACK PAIN, NECK PAIN, SHOULDER PAIN, AND KNEE PAIN FROM OSTEOARTHRITIS. ACUPUNCTURE THERAPY, INCLUDING GROUP ACUPUNCTURE, IS FEASIBLE AND EFFECTIVE, AND SPECIFICALLY SO FOR UNDERSERVED AND DIVERSE POPULATIONS AT RISK FOR HEALTH OUTCOME DISPARITIES. ACUPUNCTURE THERAPY ALSO ENCOURAGES PATIENT ENGAGEMENT AND ACTIVATION. AS CHRONIC PAIN IMPROVES, THERE IS A NATURAL PROGRESSION TO WANT AND NEED TO INCREASE ACTIVITY AND MOVEMENT RECOVERY. DIVERSE MOVEMENT APPROACHES ARE IMPORTANT FOR IMPROVING RANGE OF MOTION, MAINTAINING GAINS, STRENGTHENING, AND PROMOTING PATIENT ENGAGEMENT AND ACTIVATION. YOGA THERAPY IS AN ACTIVE THERAPY WITH PROVEN BENEFIT IN MUSCULOSKELETAL PAIN DISORDERS AND PAIN ASSOCIATED DISABILITY. THE AIM OF THIS QUASI-EXPERIMENTAL PILOT FEASIBILITY TRIAL IS TO TEST THE BUNDLING OF THESE 2 EFFECTIVE CARE OPTIONS FOR CHRONIC PAIN, TO INFORM BOTH THE DESIGN FOR A LARGER RANDOMIZED PRAGMATIC EFFECTIVENESS TRIAL AS WELL AS IMPLEMENTATION STRATEGIES ACROSS UNDERSERVED SETTINGS.	2020	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          
18 1165  50 EVALUATING THE FEASIBILITY AND IMPACT OF A YOGA INTERVENTION ON COGNITION, PHYSICAL FUNCTION, PHYSICAL ACTIVITY, AND AFFECTIVE OUTCOMES IN PEOPLE LIVING WITH HIV: PROTOCOL FOR A RANDOMIZED PILOT TRIAL. BACKGROUND: DESPITE LOWER MORTALITY RATES DUE TO COMBINATION ANTIRETROVIRAL THERAPY, PEOPLE LIVING WITH HIV (PLWH) ARE GRAPPLING WITH INCREASINGLY COMPLEX HEALTH ISSUES, INCLUDING COGNITIVE IMPAIRMENTS IN AREAS SUCH AS MEMORY, ATTENTION, PROCESSING SPEED, AND MOTOR FUNCTION. YOGA HAS BEEN SHOWN TO BE AN EFFECTIVE FORM OF EXERCISE AND MINDFULNESS-BASED STRESS REDUCTION FOR MANY CLINICAL POPULATIONS. HOWEVER, NO RANDOMIZED TRIALS HAVE EVALUATED THE IMPACT OF YOGA ON COGNITIVE AND PHYSICAL FUNCTION AMONG PLWH. OBJECTIVE: THE AIM OF THIS PILOT RANDOMIZED TRIAL WAS TO DETERMINE THE FEASIBILITY OF A YOGA INTERVENTION TO LAY THE GROUNDWORK FOR A FULL-SCALE, MULTISITE, COMMUNITY-BASED TRIAL FOR PLWH. SPECIFIC OBJECTIVES ARE TO (1) ASSESS THE FEASIBILITY OF STUDY PROTOCOL AND PROCEDURES, (2) COMPARE COGNITION IN THE YOGA GROUP WITH THE USUAL CARE CONTROL GROUP AFTER 12 WEEKS OF THE INTERVENTION IN PLWH, AND (3) COMPARE THE EFFECTS OF THE 12-WEEK YOGA INTERVENTION VERSUS CONTROL ON BALANCE, WALKING SPEED, PHYSICAL ACTIVITY, MENTAL HEALTH, MEDICATION ADHERENCE, AND QUALITY OF LIFE AMONG PLWH. METHODS: WE PROPOSE A PILOT RANDOMIZED TRIAL WITH 2 PARALLEL GROUPS (YOGA VERSUS CONTROL). WE WILL RECRUIT 25 PLWH (>35 YEARS) FROM COMMUNITY AND HEALTH ORGANIZATIONS IN HALIFAX, CANADA. AFTER BASELINE ASSESSMENT WITH BLINDED ASSESSORS, PARTICIPANTS WILL BE RANDOMLY ASSIGNED TO THE YOGA OR CONTROL GROUP, USING A RANDOM COMPUTER GENERATOR. PARTICIPANTS IN THE YOGA GROUP WILL ENGAGE IN SUPERVISED 60-MIN GROUP-BASED YOGA SESSIONS 3 TIMES A WEEK FOR 12 WEEKS AT A YOGA STUDIO. PARTICIPANTS IN THE CONTROL GROUP WILL MAINTAIN THEIR CURRENT PHYSICAL ACTIVITY LEVELS THROUGHOUT THE STUDY. RESULTS: AS PER THE CONSOLIDATED STANDARDS OF REPORTING TRIALS EXTENSION FOR PILOT STUDIES, MEANS OF ALL OUTCOMES, MEAN CHANGE, AND 95% CIS WILL BE CALCULATED FOR EACH GROUP SEPARATELY. TWO-TAILED INDEPENDENT T TESTS AND FISHER EXACT TESTS WILL BE USED TO COMPARE GROUPS AT BASELINE. WE WILL ANALYZE QUANTITATIVE POSTINTERVENTION QUESTIONNAIRE RESPONSES USING CHI-SQUARE TESTS, AND OPEN-ENDED RESPONSES WILL BE ANALYZED THEMATICALLY. INTENTION-TO-TREAT AND PER-PROTOCOL ANALYSES WILL BE USED TO ANALYZE SECONDARY VARIABLES. CHANGES IN OUTCOME VARIABLES WILL BE EXAMINED BETWEEN GROUPS AND WITHIN GROUPS. EFFECT SIZES WILL BE REPORTED FOR EACH OUTCOME. A PRIORI ADHERENCE AND SATISFACTION CRITERIA WILL BE MET IF PARTICIPANTS ATTEND >70% OF THE YOGA SESSIONS AND IF >70% OF THE PARTICIPANTS ARE SATISFIED WITH THE INTERVENTION AS DETERMINED BY A POSTPARTICIPATION QUESTIONNAIRE. STUDY ENROLLMENT BEGAN IN JANUARY 2018, WITH RESULTS EXPECTED FOR OCTOBER 2019. CONCLUSIONS: THIS PILOT RANDOMIZED TRIAL WILL BE THE FIRST TO INVESTIGATE THE FEASIBILITY AND EFFECT OF A YOGA INTERVENTION ON COGNITIVE AND PHYSICAL OUTCOMES AMONG PLWH. THIS WORK WILL INFORM THE FEASIBILITY OF FURTHER INVESTIGATIONS IN TERMS OF CAPACITY BUILDING, PARTICIPANT RECRUITMENT AND RETENTION, AND ASSESSMENT AND INTERVENTION PROTOCOLS. TRIAL REGISTRATION: CLINICALTRIALS.GOV NCT03071562; HTTPS://CLINICALTRIALS.GOV/CT2/SHOW/NCT03071562 (ARCHIVED BY WEBCITE AT HTTP://WWW.WEBCITATION.ORG/785SFHWKW). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/13818.	2019	

19 1822  38 PROTOCOL TO EVALUATE THE IMPACT OF YOGA SUPPLEMENTATION ON COGNITIVE FUNCTION IN SCHIZOPHRENIA: A RANDOMISED CONTROLLED TRIAL. BACKGROUND: SCHIZOPHRENIA (SZ) IS A CHRONIC ILLNESS THAT IS TREATED SYMPTOMATICALLY. COGNITIVE DYSFUNCTION IS A CORE FEATURE OF SZ THAT IS RELATIVELY INTRACTABLE TO PHARMACOTHERAPY. YOGA CAN IMPROVE COGNITIVE FUNCTION AMONG HEALTHY INDIVIDUALS. A RECENT OPEN TRIAL INDICATED SIGNIFICANT BENEFITS OF YOGA TRAINING (YT) IN CONJUNCTION WITH CONVENTIONAL PHARMACOTHERAPY AMONG PATIENTS WITH SZ. AIMS: TO DESCRIBE THE PROTOCOL FOR AN ONGOING RANDOMISED CONTROLLED TRIAL DESIGNED TO TEST WHETHER THE REPORTED BENEFICIAL EFFECTS OF YT ON COGNITIVE FUNCTION AMONG SZ PATIENTS CAN BE REPLICATED. SECONDARILY, THE EFFECTS OF YT ON DAILY FUNCTIONING LIVING SKILLS ARE EVALUATED. METHODS: CONSENTING PATIENTS WITH SZ RECEIVE ROUTINE CLINICAL TREATMENT AND ARE RANDOMISED TO ADJUNCTIVE YT, ADJUNCTIVE PHYSICAL EXERCISE (PE) OR TREATMENT AS USUAL (PROPOSED N = 234 TOTAL, N = 78 IN EACH GROUP). THE TRIAL INVOLVES YT OR PE 5 DAYS A WEEK AND LASTS 3 WEEKS. PARTICIPANTS ARE EVALUATED THRICE OVER 6 MONTHS. COGNITIVE FUNCTIONS MEASURED BY TRAIL MAKING TEST, UNIVERSITY OF PENNSYLVANIA NEUROCOGNITIVE COMPUTERISED BATTERY WERE PRIMARY OUTCOME MEASURES WHILE CLINICAL SEVERITY AND DAILY FUNCTIONING MEASURED BY INDEPENDENT LIVING SKILLS SURVEY WERE SECONDARY OUTCOME MEASURES. RESULTS: A TOTAL OF 309 PARTICIPANTS HAVE BEEN RANDOMISED AS OF 31 AUGUST 2013, WHICH EXCEEDED BEYOND 294 PROPOSED AFTER ATTRITION. ONCE PARTICIPANTS BEGIN YT OR PE THEY GENERALLY COMPLETE THE PROTOCOL. NO INJURIES HAVE BEEN REPORTED. CONCLUSIONS: SHORT TERM YT IS FEASIBLE AND ACCEPTABLE TO INDIAN SZ PATIENTS. IF BENEFICIAL EFFECTS OF YT ARE DETECTED, IT WILL PROVIDE A NOVEL ADJUNCTIVE COGNITIVE REMEDIATION STRATEGY FOR SZ PATIENTS.	2014	
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      
20  131  32 A PRAGMATIC MULTI-CENTRED RANDOMISED CONTROLLED TRIAL OF YOGA FOR CHRONIC LOW BACK PAIN: TRIAL PROTOCOL. UNLABELLED: A SYSTEMATIC REVIEW REVEALED THREE SMALL RANDOMISED CONTROLLED TRIALS OF YOGA FOR LOW BACK PAIN, ALL OF WHICH SHOWED EFFECTS ON BACK PAIN THAT FAVOURED THE YOGA GROUP. TO BUILD ON THESE STUDIES A LARGER TRIAL, WITH LONGER TERM FOLLOW-UP, AND A NUMBER OF DIFFERENT YOGA TEACHERS DELIVERING THE INTERVENTION IS REQUIRED. THIS STUDY PROTOCOL DESCRIBES THE DETAILS OF A RANDOMISED CONTROLLED TRIAL (RCT) TO DETERMINE THE EFFECTIVENESS AND COST-EFFECTIVENESS OF YOGA FOR CHRONIC LOW BACK PAIN, WHICH IS FUNDED BY ARTHRITIS RESEARCH CAMPAIGN (ARC) AND IS BEING CONDUCTED BY THE UNIVERSITY OF YORK. 262 PATIENTS WILL BE RECRUITED FROM GP PRACTICES IN 5 CENTRES IN ENGLAND. PATIENTS WILL BE RANDOMISED TO RECEIVE USUAL CARE OR 12 WEEKLY CLASSES OF YOGA. A YOGA PROGRAMME WILL BE DEVISED THAT CAN BE DELIVERED BY YOGA TEACHERS OF THE TWO MAIN NATIONAL YOGA ORGANISATIONS IN THE UK (BRITISH WHEEL OF YOGA AND IYENGAR YOGA ASSOCIATION (UK)). TRIAL REGISTRATION: CURRENT CONTROLLED TRIALS REGISTRY ISRCTN81079604 (DATE REGISTERED 30/03/2007).	2010