About this trial
The goal of this clinical trial is to determine if a weekly regimen of Medical Massage Therapy (MMT) with provider-directed care shortens the duration of Medically Restricted Duty Days (MRDD) periods in Active-Duty Service Members with Subacute Lower Back Pain (LBP) compared to provider-directed care alone.
The main question the study aims to answer is, when used as an adjunct to provider-directed care, a consistent program of MMT provided by a qualified practitioner, will shorten the duration of MRDD periods, reduce pain, and decrease unnecessary healthcare utilization in patients with Subacute LBP compared to provider-directed care alone. Researchers will study this hypothesis through the comparison of Group #1 (provider-directed care alone) and Group #2 (provider-directed care and MMT).
Participants randomized into the two study groups will be following a 12-week study design (+/- 2 weeks) comprised of their compliance to their provider-directed care, the study intervention (if randomized to Group #2) and study case report forms (CRFs); with a final follow up visit (up to 4 weeks following their final treatment visit).
Eligibility criteria
Qualifiers
Active-duty service member
18-64 (inclusive) years of age
Medical evidence of subacute low back pain (as indicated by complications lasting 1-3 months)
Willingness to comply with treatment and follow-up schedule
Disqualifiers
Presence of significant comorbid pain (e.g., polytrauma)
Cancer - active/ongoing treatment for
Active Infections, including skin lesions and rashes
Flu or other severe cold virus or COVID
Trial design
Treatments tested in this trial
- Medical Massage Therapy
- Provider Directed Care
Treatment groups
Sponsors and collaborators
The Geneva Foundation
Lead sponsor
Uniformed Services University of the Health Sciences
Collaborator
Madigan Army Medical Center
Collaborator