Recruiting

MMT & Provider-Directed Care

Sponsor:

The Geneva Foundation

Code:

NCT07615816

Conditions

Lower Back Pain

Subacute Lower Back Pain

Medical Massage Therapy

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Interventions

Medical Massage Therapy

Provider Directed Care

Study Details

Brief summary:

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).

Conditions

Lower Back Pain

Subacute Lower Back Pain

Medical Massage Therapy

Study ID

NCT07615816

Start date

Jun 1, 2026

Status verified date

Jun, 2026

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

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
  • Symptomatic Inflammatory/Autoimmune diseases such as Rheumatoid
  • Arthritis and Ankylosing Spondylitis. Acute exacerbation and not in remission
  • High Grade Spondylolisthesis (Grade III and Grade IV)
  • Fibromyalgia
  • Severe Osteoporosis (BMD with T-score of -2.5 or lower, along with the presence of one or more fragility fractures)
  • Neurogenic conditions
  • Spinal Stenosis with active neurogenic claudication
  • Cauda Equina Syndrome - acute
  • Radiating pain below the knee or in the presence of true Neurological signs (numbness/weakness)
  • Historical dx of any of the following:
  • Spinal Cord injuries with persisting neurogenic sensory or motor loss
  • Lumbar spine back surgery within the past year
  • Received spinal interventions (e.g., surgery, nerve ablations, steroid injections, etc.) within the past 6 months
  • Current use of blood thinners/anticoagulants
  • Is enrolled or plans to enroll in another clinical trial during this study that would affect the patient's safety or results of this trial
  • \[Females only\] Currently pregnant (self-reported) or plans to become pregnant during the study intervention period

Study Design

Enrollment

220 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Group #1

Provider-directed care

active comparator: Group #2

Provider-directed care and Medical Massage Therapy

Interventions

Medical Massage Therapy

Massage and educational treatment provided by a licensed massage therapist.

Provider Directed Care

Provider directed care (i.e. Physical 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) ]
  • Satisfaction and Treatment History Self-Reported Data [ Time Frame: Week 1-12 Visits, and Final Follow-up Visit (up to 16 weeks after Baseline Visit) ]
  • Work Productivity and Activity Impairment Questionnaire (WPAI-LBP) [ Time Frame: Baseline Visit, Week 1-12 Visits, and Final Follow-up Visit (up to 16 weeks after Baseline Visit) ]
  • Defense and Veterans Pain Rating Scale (DVPRS) [ Time Frame: Baseline Visit, Week 1-12 Visits, and Final Follow-up Visit (up to 16 weeks after Baseline Visit) ]
  • Global Pain Scale (GPS) [ 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) ]
  • Global Rating of Change Score (GRoC) [ Time Frame: Week 1 Visit, Week 6 Visit, Week 12 Visit, and Final Follow-up Visit (up to 16 weeks after Baseline Visit) ]
  • Patient-Reported Outcomes Measurement Information System (PROMIS-29) [ 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) ]
  • Physical Therapy Appointment History [ Time Frame: Week 1-12 Visits, and Final Follow-up Visit (up to 16 weeks after Baseline Visit) ]
  • Military Specific Duty Status [ Time Frame: Baseline Visit, Week 1-12 Visits, and Final Follow-up Visit (up to 16 weeks after Baseline Visit) ]

Central Contacts and Locations

Central contacts

Janel Son, MPH

253-968-3288json@genevausa.org

Brad M. Isaacson, PhD, MBA, MSF, PMP

brad.isaacson.ctr@usuhs.edu

Locations

Madigan Army Medical Center

Recruiting

Joint Base Lewis McChord, Washington, United States, 98431

Contacts

Janel Son, MPH

253-968-3288json@genevausa.org

Ghena Grinshpun, DO

german.grinshpun.civ@health.mil

More Information

Sponsor

The Geneva Foundation

Last update posted

Jun 5, 2026

Last verified

Jun, 2026

Keywords

  • Medical Massage Therapy
  • Active Duty Service Members
  • Subacute Lower Back Pain
  • Lower Back Pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Geneva Foundation on 2026-06-05.