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

NCT07615816 | Recruiting

• 2 other identifiers: 226029HU00012520022
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (9)

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

  The M-ODI is the most commonly used aid for evaluating disability due to LBP This free instrument delivers medical provider information related to functional limitation and pain management.

  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

  Participants will self-report differences in healthcare utilization and prescription medication fulfillment, as well as satisfaction with care.

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

• Work Productivity and Activity Impairment Questionnaire (WPAI-LBP)

  The Work Productivity and Activity Impairment (WPAI) Low Back Pain (LBP) questionnaire is an instrument used to assess the impact of low back pain on a person's ability to work and perform daily activities. The questionnaire focuses on absenteeism (missing work), presenteeism (reduced productivity at work), and limitations in non-work activities due to low back pain.

  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)

  The Defense and Veterans Pain Rating Scale (DVPRS 2.0) is a pain assessment tool that utilizes a numerical rating scale enhanced by functional word descriptors, color coding, and pictorial facial expressions matched to pain levels.

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

• Global Pain Scale (GPS)

  The GPS is a comprehensive assessment of pain evaluating pain, emotions, clinical outcomes, and daily activities,. This may be a valuable tool for evaluation and treatment planning for interventional pain management physicians.

  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)

  The GRoC is a frequently used outcome measure that has ben used to independently score self-perceived improvement in a patient and has been used as an anchor method to determine minimal clinically important change scores. The GRoC is a single-item, recall-based questionnaire of well-being that is based on progress since an initial treatment encounter.

  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)

  The PROMIS-29 v2.0 profile assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain.

  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

  How many PT appointments since last study visit, which body part(s) treated, what treatment modalities were performed?

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

• Military Specific Duty Status

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

Study Arms (2)

Group #1

PLACEBO COMPARATOR

Provider-directed care

Other: Provider Directed Care

Group #2

ACTIVE COMPARATOR

Provider-directed care and Medical Massage Therapy

Procedure: Medical Massage Therapy; Other: Provider Directed Care

Interventions

Provider Directed Care OTHER

Provider directed care (i.e. Physical Therapy)

Group #1; Group #2

Medical Massage Therapy PROCEDURE

Massage and educational treatment provided by a licensed massage therapist.

Group #2

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Active-duty service member
• (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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Geneva Foundation: lead
• Uniformed Services University of the Health Sciences: collaborator
• Madigan Army Medical Center: collaborator

Study Sites (1)

Madigan Army Medical Center

Joint Base Lewis McChord, Washington, 98431, United States

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ghena G. Grinshpun, PhD, MBA, MSF, PMP

  Madigan Army Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Janel Son, MPH

CONTACT

253-968-3288; json@genevausa.org

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

CONTACT

brad.isaacson.ctr@usuhs.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to one of two treatment groups: provider-directed care, or provider-directed care plus medical massage therapy.

Study Record Dates

• First Submitted: May 1, 2026
• First Posted: May 29, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)