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

Part of paid clinical trials in Joint Base Lewis McChord, Washington.

Sponsor
The Geneva Foundation
Study ID
NCT07615816
Status
Recruiting
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Conditions

  • Lower Back Pain
  • Medical Massage Therapy
  • Subacute Lower Back Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • Medical Massage Therapy — PROCEDURE
    Massage and educational treatment provided by a licensed massage therapist.
  • Provider Directed Care — OTHER
    Provider directed care (i.e. Physical Therapy)

Study Details

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).

Key Dates

Start date
Jun 1, 2026
Status verified
Jun 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
220 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Group #1
    Provider-directed care
  • Active Comparator: Group #2
    Provider-directed care and Medical Massage Therapy

Primary Outcome Measure

Modified Oswestry Low Back Pain Disability Index (M-ODI) [ Time Frame: Baseline Visit, Week 1 Visit, Week 6 Visit, Week 12 Visit, and Final Follow-up Visit (up to 16 weeks after Baseline Visit) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Madigan Army Medical CenterJoint Base Lewis McChordWashington98431
Janel Son, MPH
[email protected]
253-968-3288
Ghena Grinshpun, DO
[email protected]

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By research site
Madigan Army Medical Center· Joint Base Lewis McChord, WA

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