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Massage, Sleep , and Pain

Sleep as a Mediator of Pain Relief Following Massage Therapy for Chronic Pain: Pilot and Efficacy Study

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07783139
Enrollment
120
Registered
2026-08-24
Start date
2026-10-01
Completion date
2028-09-01
Last updated
2026-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Musculoskeletal Pain, Sleep Disturbances

Keywords

massage therapy, chronic pain, sleep disturbances, actigraphy, military personnel

Brief 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.

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.

Interventions

BEHAVIORALSemi-Standardized Integrative Therapeutic Massage

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.

OTHERUsual Care

Standard pharmacologic, physical therapy, and medical management directed by primary care or specialty providers.

Sponsors

Defense and Veterans Center for Integrative Pain Management
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Randomized, wait-list-controlled clinical trial comparing massage therapy plus usual care versus usual care alone.

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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 \-

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline in Pain Intensity on Defense and Veterans Pain Rating Scale (DVPRS)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 EfficiencyWeek 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.

Secondary

MeasureTime frameDescription
Change from Baseline in Insomnia Severity Index (ISI) Total ScoreBaseline (Week 0), Weeks 2, 4, 6, 8, and 127-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).
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Global ScoreBaseline (Week 0), Week 4, Week 8, and WeekSelf-report questionnaire evaluating 7 domains of sleep quality over the past month (score range: 0-21, higher scores indicate worse sleep quality).

Countries

United States

Contacts

CONTACTMary McDuffie, MS RN BSN
mary.mcduffie.ctr@usuhs.edu3015388785
STUDY_CHAIRTracy Rupp, PhD

USU/DVCIPM

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 25, 2026