Chronic Musculoskeletal PainNCT07783139
Massage, Sleep , and Pain
A study testing Semi-Standardized Integrative Therapeutic Massage in people with Chronic Musculoskeletal Pain and Sleep Disturbances, run by Defense and Veterans Center for Integrative Pain Management at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Musculoskeletal Pain, Sleep Disturbances
- What is being tested?
- Semi-Standardized Integrative Therapeutic Massage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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, 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
-
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Walter Reed national Military Medical Center
Bethesda, Maryland, 20889
Mary E McDuffie, RN MS BSN, 3015388785, mary.mcduffie.ctr@usuhs.edu
Harold J Gelfand, MD
About this study
Official title: Sleep as a Mediator of Pain Relief Following Massage Therapy for Chronic Pain: Pilot and Efficacy Study
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.
Read the detailed description
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.
- Conditions
- Chronic Musculoskeletal Pain, Sleep Disturbances
- Being tested
- Semi-Standardized Integrative Therapeutic Massage, Usual Care
- Keywords
- massage therapy, chronic pain, sleep disturbances, actigraphy, military personnel
- Medical subject headings
- Parasomnias, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-Standardized Integrative Therapeutic MassageBehavioural
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.
Usual CareOther
Standard pharmacologic, physical therapy, and medical management directed by primary care or specialty providers.
| Study group | Role | What they receive |
|---|---|---|
| Massage Therapy + Usual Care | Experimental | 6 weeks of semi-standardized integrative therapeutic massage Receives: Behavioral: Semi-Standardized Integrative Therapeutic Massage |
| Usual Care Alone (Wait-List Control) | Active comparator | continue standard provider-prescribed medical and rehabilitative care alone for 12 weeks, Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Week 0 through Week 8.
Secondary outcomes (2)
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).
Measured: 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).
Measured: Baseline (Week 0), Week 4, Week 8, and Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Musculoskeletal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, wait-list-controlled clinical trial comparing massage therapy plus usual care versus usual care alone.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Defense and Veterans Center for Integrative Pain Management
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tracy Rupp, PhD, Study chair, USU/DVCIPM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07783139
- Sponsor's protocol ID
- DVCIPM
- Other IDs
- HU0001262E011
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep as a Mediator of Pain Relief Following Massage Therapy for Chronic Pain: Pilot and Efficacy Study
- ClinicalTrials.gov ID
- NCT07783139
- Acronym / sponsor ID
- DVCIPM
- Conditions
- Chronic Musculoskeletal Pain, Sleep Disturbances
- Keywords
- massage therapy, chronic pain, sleep disturbances, actigraphy, military personnel
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Defense and Veterans Center for Integrative Pain ManagementUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 24 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, wait-list-controlled clinical trial comparing massage therapy plus usual care versus usual care alone.
| Arm | Type | Receives |
|---|---|---|
| Massage Therapy + Usual Care | Experimental | Behavioral: Semi-Standardized Integrative Therapeutic Massage6 weeks of semi-standardized integrative therapeutic massage |
| Usual Care Alone (Wait-List Control) | Active comparator | Other: Usual Carecontinue standard provider-prescribed medical and rehabilitative care alone for 12 weeks, |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semi-Standardized Integrative Therapeutic Massage45-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. | Behavioural | Massage Therapy + Usual Care |
| Usual CareStandard pharmacologic, physical therapy, and medical management directed by primary care or specialty providers. | Other | Usual Care Alone (Wait-List Control) |
Primary outcome
Change from Baseline in Pain Intensity on Defense and Veterans Pain Rating Scale (DVPRS)
Time frame: Baseline (Week 0), weekly during intervention (Weeks 1-6), Post-treatment (Week 8), and Follow-up (Week 12).
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.
Change from Baseline in Actigraphy-Derived Sleep Efficiency
Time frame: Week 0 through Week 8.
Objective sleep quality measured via continuous wrist actigraphy, calculated as the percentage of time spent asleep relative to total time spent in bed.
2 secondary outcomes
Change from Baseline in Insomnia Severity Index (ISI) Total Score
Time frame: Baseline (Week 0), Weeks 2, 4, 6, 8, and 12
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Global Score
Time frame: Baseline (Week 0), Week 4, Week 8, and Week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tracy Rupp, PhD study chair
USU/DVCIPM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Semi-Standardized Integrative Therapeutic Massage in people with Chronic Musculoskeletal Pain and Sleep Disturbances, run by Defense and Veterans Center for Integrative Pain Management at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary McDuffie, MS RN BSN (3015388785, mary.mcduffie.ctr@usuhs.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Pain Intensity on Defense and Veterans Pain Rating Scale (DVPRS) (time frame: Baseline (Week 0), weekly during intervention (Weeks 1-6), Post-treatment (Week 8), and Follow-up (Week 12).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.