Investigating Medical Massage Therapy for Patients With Sub-Acute Lower Back Pain

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorThe Geneva Foundation

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

220 Participants
are divided into 2 treatment groups

Sponsors and collaborators

The Geneva Foundation

Lead sponsor

Uniformed Services University of the Health Sciences

Collaborator

Madigan Army Medical Center

Collaborator