RecruitingNot Applicable

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

United States220 participantsStarted 2026-06-01

Plain-language 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).

Who can participate

Age range

18 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 anothe…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Modified Oswestry Low Back Pain Disability Index (M-ODI)

Timeframe: 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

Timeframe: Week 1-12 Visits, and Final Follow-up Visit (up to 16 weeks after Baseline Visit)

Work Productivity and Activity Impairment Questionnaire (WPAI-LBP)

Timeframe: 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)

Timeframe: Baseline Visit, Week 1-12 Visits, and Final Follow-up Visit (up to 16 weeks after Baseline Visit)

Global Pain Scale (GPS)

Timeframe: 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)

Timeframe: Week 1 Visit, Week 6 Visit, Week 12 Visit, and Final Follow-up Visit (up to 16 weeks after Baseline Visit)

Trial details

NCT IDNCT07615816

SponsorThe Geneva Foundation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01-31

Contact for this trial

Janel Son, MPH

253-968-3288 json@genevausa.org

View on ClinicalTrials.gov More Lower Back Pain trials

Plain-language summary

Who can participate

Age range

18 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Modified Oswestry Low Back Pain Disability Index (M-ODI)

Timeframe: 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

Timeframe: Week 1-12 Visits, and Final Follow-up Visit (up to 16 weeks after Baseline Visit)

Work Productivity and Activity Impairment Questionnaire (WPAI-LBP)

Timeframe: 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)

Timeframe: Baseline Visit, Week 1-12 Visits, and Final Follow-up Visit (up to 16 weeks after Baseline Visit)

Global Pain Scale (GPS)

Timeframe: 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)

Timeframe: Week 1 Visit, Week 6 Visit, Week 12 Visit, and Final Follow-up Visit (up to 16 weeks after Baseline Visit)