NCT07615816 Investigating Medical Massage Therapy for Patients With Sub-Acute Lower Back Pain
| NCT ID | NCT07615816 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Geneva Foundation |
| Condition | Lower Back Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 220 participants in total. It began in 2026-06-01 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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
Contact & Investigator
Ghena G. Grinshpun, PhD, MBA, MSF, PMP
PRINCIPAL INVESTIGATOR
Madigan Army Medical Center
Frequently Asked Questions
Who can join the NCT07615816 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 64 Years, studying Lower Back Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07615816 currently recruiting?
Yes, NCT07615816 is actively recruiting participants. Contact the research team at json@genevausa.org for enrollment information.
Where is the NCT07615816 trial being conducted?
This trial is being conducted at Joint Base Lewis McChord, United States.
Who is sponsoring the NCT07615816 clinical trial?
NCT07615816 is sponsored by The Geneva Foundation. The principal investigator is Ghena G. Grinshpun, PhD, MBA, MSF, PMP at Madigan Army Medical Center. The trial plans to enroll 220 participants.