Massage, Sleep , and Pain

NCT07783139 | Not Yet Recruiting

• 2 other identifiers: DVCIPMHU0001262E011
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Musculoskeletal Pain; Sleep Disturbances

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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).

• 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.

Secondary Outcomes (2)

• Change from Baseline in Insomnia Severity Index (ISI) Total Score

  Baseline (Week 0), Weeks 2, 4, 6, 8, and 12

• Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Global Score

  Baseline (Week 0), Week 4, Week 8, and Week

Other Outcomes (2)

• Change from Baseline in PROMIS-29 Domain T-Scores

  Baseline (Week 0), weekly through Week 8, and

• Change from Baseline in Pain Catastrophizing (UW-CAP SF-6 T-Score)

  Baseline (Week 0), weekly through Week 8, and Week 12

Study Arms (2)

Massage Therapy + Usual Care

EXPERIMENTAL

6 weeks of semi-standardized integrative therapeutic massage

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,

Other: Usual Care

Interventions

Semi-Standardized Integrative Therapeutic Massage BEHAVIORAL

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.

Massage Therapy + Usual Care

Usual Care OTHER

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

Usual Care Alone (Wait-List Control)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Defense and Veterans Center for Integrative Pain Management: lead

Study Sites (1)

Walter Reed national Military Medical Center

Bethesda, Maryland, 20889, United States

Location

MeSH Terms

Conditions

Parasomnias; Chronic Pain

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tracy Rupp, PhD

  USU/DVCIPM

  STUDY CHAIR

Central Study Contacts

Mary McDuffie, MS RN BSN

CONTACT

3015388785; mary.mcduffie.ctr@usuhs.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 24, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)