Massage, Sleep , and Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorDefense and Veterans Center for Integrative Pain Management
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Semi-Standardized Integrative Therapeutic Massage
Behavioral45-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 interventionStandard pharmacologic, physical therapy, and medical management directed by primary care or specialty providers.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Massage Therapy + Usual CareExperimental treatment 1 intervention
Group B: Usual Care Alone (Wait-List Control)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).2
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.Secondary outcomes
1
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 122
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 WeekOther outcomes
1
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, and2
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 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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