The Geneva Foundation
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).
Musculoskeletal injuries (MSKI) affect approximately 800,000 service members (SMs) annually and result in 25 million days of limited duty. These conditions account for 34% of medical evacuations from theatre, and are the primary reasons for medical separation. Low back pain (LBP) is the leading cause of MSKI amongst active-duty service members (ADSMs) with a lifetime prevalence rate of up to 80%. The burden of disease for LBP is reaching $100 billion annually in the United States and new methods for prevention and treatment are necessary. At the present time, there is no "gold standard" for L…
Inclusion Criteria: * 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 * Ability and willingness to provide written informed consent Exclusion Criteria: * Current dx of any of the following: * 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 * Severe depression or anxiety * Symptoma…
Massage and educational treatment provided by a licensed massage therapist.
Provider directed care (i.e. Physical Therapy)
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