An interventional study of Semi-Standardized Integrative Therapeutic Massage and Usual Care in Chronic Musculoskeletal Pain and Sleep Disturbances, sponsored by Defense and Veterans Center for Integrative Pain Management. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by Defense and Veterans Center for Integrative Pain Management · Not applicable, Interventional, and Treatment
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.
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.
3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.
This study's planned enrollment of 120 is above the median of 60 across 2,388 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Defense and Veterans Center for Integrative Pain Management is the lead sponsor of 22 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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 -
Exclusion 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, 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 or attend weekly sessions at WRNMMC
-
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
6 weeks of semi-standardized integrative therapeutic massage
Behavioral: Semi-Standardized Integrative Therapeutic Massage
continue standard provider-prescribed medical and rehabilitative care alone for 12 weeks,
Other: Usual Care
45-minute sessions delivered by a licensed therapist incorporating 15 minutes of head/neck nervous system calming followed by Swedish techniques, myofascial release, passive range of motion, and localized trigger point work using moderate pressure.
Standard pharmacologic, physical therapy, and medical management directed by primary care or specialty providers.
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.
Time frame: Baseline (Week 0), weekly during intervention (Weeks 1-6), Post-treatment (Week 8), and Follow-up (Week 12).
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.
Time frame: Week 0 through Week 8.
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).
Time frame: Baseline (Week 0), Weeks 2, 4, 6, 8, and 12
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).
Time frame: Baseline (Week 0), Week 4, Week 8, and Week
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).
Time frame: Baseline (Week 0), weekly through Week 8, and
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).
Time frame: Baseline (Week 0), weekly through Week 8, and Week 12
Plan to share: No — Individual participant data will not be made publicly available or shared for future secondary research studies outside authorized institutional agreements. Coded research data will be maintained on secure servers for 7 years post-study per institutional guidelines.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Sep 2028, 23 months later.
Of 1,295 non-industry interventional studies with no phase under Chronic Pain, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 39. This study's planned 23 months is above that.
Counting every sponsor, half of 1,378 studies reached it within 20 months; a quarter within 9 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Defense and Veterans Center for Integrative Pain Management