[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653088":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":43,"studyPopulation":40,"armGroups":44,"interventions":57,"overallOfficials":67,"centralContacts":72,"locations":78,"responsibleParty":98,"collaborators":40,"id":100,"slug":101,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":40,"eligibilityCriteria":106,"healthyVolunteers":102,"sex":107,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":40,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":120,"overallStatus":126,"whyStopped":40,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},{"fullName":5,"class":6},"Defense and Veterans Center for Integrative Pain Management","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":26},[9,13],{"measure":10,"description":11,"timeFrame":12},"Change from Baseline in Pain Intensity on Defense and Veterans Pain Rating Scale (DVPRS)","Self-reported pain severity measured on a 0-10 numeric rating scale (0 = no pain, 10 = worst possible pain). Primary endpoint is change from Week 0 to Week 8.","Baseline (Week 0), weekly during intervention (Weeks 1-6), Post-treatment (Week 8), and Follow-up (Week 12).",{"measure":14,"description":15,"timeFrame":16},"Change from Baseline in Actigraphy-Derived Sleep Efficiency","Objective sleep quality measured via continuous wrist actigraphy, calculated as the percentage of time spent asleep relative to total time spent in bed.","Week 0 through Week 8.",[18,22],{"measure":19,"description":20,"timeFrame":21},"Change from Baseline in Insomnia Severity Index (ISI) Total Score","7-item questionnaire evaluating the severity of sleep onset, sleep maintenance, and daytime impact of insomnia symptoms (score range: 0-28, higher scores indicate greater insomnia severity).","Baseline (Week 0), Weeks 2, 4, 6, 8, and 12",{"measure":23,"description":24,"timeFrame":25},"Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Global Score","Self-report questionnaire evaluating 7 domains of sleep quality over the past month (score range: 0-21, higher scores indicate worse sleep quality).","Baseline (Week 0), Week 4, Week 8, and Week",[27,31],{"measure":28,"description":29,"timeFrame":30},"Change from Baseline in PROMIS-29 Domain T-Scores","Standardized measures assessing pain interference, physical function, fatigue, sleep disturbance, anxiety, and depression (scored using T-scores, Mean = 50, SD = 10).","Baseline (Week 0), weekly through Week 8, and",{"measure":32,"description":33,"timeFrame":34},"Change from Baseline in Pain Catastrophizing (UW-CAP SF-6 T-Score)","6-item short form measuring distressing thoughts and hopelessness associated with pain (standardized T-score, Mean = 50, SD = 10).","Baseline (Week 0), weekly through Week 8, and Week 12",{"allocation":36,"interventionModel":37,"interventionModelDescription":38,"primaryPurpose":39,"observationalModel":40,"timePerspective":40,"maskingInfo":41},"RANDOMIZED","PARALLEL","Randomized, wait-list-controlled clinical trial comparing massage therapy plus usual care versus usual care alone.","TREATMENT",null,{"masking":42,"maskingDescription":40,"whoMasked":40},"NONE","Chronic musculoskeletal pain and sleep disturbances are highly prevalent among active-duty military personnel and adversely affect force readiness and operational performance. Sleep and pain are bidirectionally linked: poor sleep amplifies pain perception, while pain disrupts sleep quality. Massage therapy is widely utilized for pain relief, but the mechanisms driving improvement remain unclear. This study evaluates whether a 6-week semi-standardized integrative therapeutic massage intervention improves sleep quality and pain outcomes compared with usual care in active-duty service members with chronic back, neck, or shoulder pain. Objective sleep parameters will be tracked continuously using wrist actigraphy alongside prospective daily sleep and pain diaries. The study also explores whether sleep changes statistically mediate pain relief.",[45,51],{"label":46,"type":47,"description":48,"interventionNames":49},"Massage Therapy + Usual Care","EXPERIMENTAL","6 weeks of semi-standardized integrative therapeutic massage",[50],"Behavioral: Semi-Standardized Integrative Therapeutic Massage",{"label":52,"type":53,"description":54,"interventionNames":55},"Usual Care Alone (Wait-List Control)","ACTIVE_COMPARATOR","continue standard provider-prescribed medical and rehabilitative care alone for 12 weeks,",[56],"Other: Usual Care",[58,63],{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":40},"BEHAVIORAL","Semi-Standardized Integrative Therapeutic Massage","45-minute sessions delivered by a licensed therapist incorporating 15 minutes of head\u002Fneck nervous system calming followed by Swedish techniques, myofascial release, passive range of motion, and localized trigger point work using moderate pressure.",[46],{"type":6,"name":64,"description":65,"armGroupLabels":66,"otherNames":40},"Usual Care","Standard pharmacologic, physical therapy, and medical management directed by primary care or specialty providers.",[52],[68],{"name":69,"affiliation":70,"role":71},"Tracy Rupp, PhD","USU\u002FDVCIPM","STUDY_CHAIR",[73],{"name":74,"role":75,"phone":76,"phoneExt":40,"email":77},"Mary McDuffie, MS RN BSN","CONTACT","3015388785","mary.mcduffie.ctr@usuhs.edu",[79],{"facility":80,"status":40,"city":81,"state":82,"zip":83,"country":84,"countryCode":85,"cosmosGeoPoint":86,"geoPoint":91,"contacts":92},"Walter Reed national Military Medical Center","Bethesda","Maryland","20889","United States","US",{"type":87,"coordinates":88},"Point",[89,90],-77.10026,38.98067,{"lat":90,"lon":89},[93,95],{"name":94,"role":75,"phone":76,"phoneExt":40,"email":77},"Mary E McDuffie, RN MS BSN",{"name":96,"role":97,"phone":40,"phoneExt":40,"email":40},"Harold J Gelfand, MD","PRINCIPAL_INVESTIGATOR",{"type":99,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100653088","massage-sleep--and-pain-100653088",false,"NCT07783139","Massage, Sleep , and Pain","Sleep as a Mediator of Pain Relief Following Massage Therapy for Chronic Pain: Pilot and Efficacy Study","Inclusion Criteria: Active-duty military service member Age 18 to 60 years Self-reported chronic back, neck, or shoulder pain for at least 3 m onths (≥3 months) Baseline pain severity score of 4 or greater (DVPRS ≥4) Able to read and understand English Access to a smartphone, tablet, or computer for survey completion -\n\nExclusion Criteria: Criteria:Provider recommendation against massage therapy Undergone surgery within the prior 3 months Pregnancy Received clinical massage therapy within the prior 12 months Diagnosed with Complex Regional Pain Syndrome (CRPS), Fibromyalgia, Chronic Fatigue Syndrome, Autoimmune disease-related pain, Advanced neuropathies, or Active cancer-related pain Diagnosed Obstructive Sleep Apnea (OSA) that is untreated or non-adherent with therapy History of severe traumatic brain injury (TBI) Severe psychiatric di sorder Inability to provide informed consent or attend weekly sessions at WRNMMC\n\n\\-","ALL","18 Years","60 Years",{"count":111,"type":112},120,"ESTIMATED","INTERVENTIONAL",[115],"NA","This study evaluates whether a 6-week semi-standardized integrative therapeutic massage intervention improves sleep quality and pain outcomes compared with usual care in active-duty service members with chronic back, neck, or shoulder pain.",[118,119],"Chronic Musculoskeletal Pain","Sleep Disturbances",[121,122,123,124,125],"massage therapy","chronic pain","sleep disturbances","actigraphy","military personnel","NOT_YET_RECRUITING","2026-08-20",{"date":129,"type":130},"2026-08-24","ACTUAL",{"date":132,"type":112},"2026-10-01",{"date":134,"type":112},"2028-09",{"name":5,"class":6},1]