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

Phase

N/A

Condition

Lower Back Pain

Treatment

Medical Massage Therapy

Provider Directed Care

Clinical Study ID

NCT07615816

226029

HU00012520022

Ages 18-64
All Genders

Study 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

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

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 ofone 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 thatwould affect the patient's safety or results of this trial
[Females only] Currently pregnant (self-reported) or plans to become pregnant duringthe study intervention period

Study Design

Medical Massage Therapy

June 01, 2026

January 31, 2027

Study Description

Musculoskeletal injuries (MSKI) affect approximately 800,000 service members (SMs) annually and result in 25 million days of limited duty. These conditions account for 34% of medical evacuations from theatre, and are the primary reasons for medical separation. Low back pain (LBP) is the leading cause of MSKI amongst active-duty service members (ADSMs) with a lifetime prevalence rate of up to 80%. The burden of disease for LBP is reaching $100 billion annually in the United States and new methods for prevention and treatment are necessary.

At the present time, there is no "gold standard" for LBP management and strong evidence as to what is most beneficial is lacking. One of the most promising medical options for LBP is massage therapy (MT), given that no special equipment is needed, it can be delivered anywhere, it is non-habit forming, and the likelihood for serious harm is low. Massage therapy is unique in that it can naturally enhance local blood flow, thereby providing vital oxygen and nutrients to areas damaged by MSKI to promote healing, offers relaxation and normalization of soft tissue which reduces pain, lessens swelling, clears local pain mediators, improves cognitive/psychosocial complications (e.g., depression, anxiety, etc.), aids in sleep quality, and provides a positive hormone release. To date, however, there has not been a large randomized control trial (RCT) performed on patients with subacute LBP to demonstrate healing and preventing patients from becoming chronically injured.

To address this limitation, we will enroll a total of 200 patients to assess the efficacy of medical massage therapy (MMT) combined with standard of care (SoC) in ADSMs with subacute LBP (intervention) as compared to SoC only (control). Five specific aims have been designed to understand if weekly MMT can reduce medically restricted duty days (MRDD) (Aim #1), decrease pain/disability and improve sleep quality (Aim #2), and lessen the need for prescription medications (Aim #3). Data will be aggregated at the end of the study through survey tools and self-reported information to understand the economic impact of (Aim #4) and to understand which patient phenotypes are optimal for future care (Aim #5).

Connect with a study center

Madigan Army Medical Center
Joint Base Lewis McChord, Washington 98431
United States
Active - Recruiting

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