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NCT Number: NCT07783139

Massage, Sleep , and Pain

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.

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Key information

Conditions

Chronic Musculoskeletal Pain Chronic Pain Mental Disorders Nervous System Diseases Neurologic Manifestations Pain Parasomnias Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disturbances Sleep Wake Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Walter Reed national Military Medical Center

Bethesda, Maryland, 20889, United States

Location contact

Harold J Gelfand, MD

PRINCIPAL_INVESTIGATOR

Mary E McDuffie, RN MS BSN

CONTACT

[email protected]

3015388785

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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Treatment and study plan

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.

Usual Care

Other

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

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

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

    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).

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

    Time frame: Baseline (Week 0), Week 4, Week 8, and Week

    Self-report questionnaire evaluating 7 domains of sleep quality over the past month (score range: 0-21, higher scores indicate worse sleep quality).

Other outcomes

  1. Change from Baseline in PROMIS-29 Domain T-Scores

    Time frame: Baseline (Week 0), weekly through Week 8, and

    Standardized measures assessing pain interference, physical function, fatigue, sleep disturbance, anxiety, and depression (scored using T-scores, Mean = 50, SD = 10).

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

    Time frame: Baseline (Week 0), weekly through Week 8, and Week 12

    6-item short form measuring distressing thoughts and hopelessness associated with pain (standardized T-score, Mean = 50, SD = 10).

Study contacts

Contact information is provided by the study sponsor or research team.

Mary McDuffie, MS RN BSN

CONTACT

[email protected]

3015388785

Sponsors and collaborators

Lead sponsor

Defense and Veterans Center for Integrative Pain Management

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 24, 2026
Registry last updated
Aug 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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