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

Locations

1
Madigan Army Medical Center98431, Joint Base Lewis McChordWashington, United States

Sponsors and collaborators

The Geneva Foundation

Lead sponsor

Uniformed Services University of the Health Sciences

Collaborator

Madigan Army Medical Center

Collaborator