NCT07615816 · The Geneva Foundation
Investigating Medical Massage Therapy for Patients With Sub-Acute Lower Back Pain
(Zeel LBP)
What this study is about
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.
View original scientific description
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).
Interventions
PROCEDURE
Medical Massage Therapy
Massage and educational treatment provided by a licensed massage therapist.
OTHER
Provider Directed Care
Provider directed care (i.e. Physical Therapy)
Primary outcome measures
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)
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.
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)
Participants will self-report differences in healthcare utilization and prescription medication fulfillment, as well as satisfaction with care.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
Physical Therapy Appointment History
Time frame: Week 1-12 Visits, and Final Follow-up Visit (up to 16 weeks after Baseline Visit)
How many PT appointments since last study visit, which body part(s) treated, what treatment modalities were performed?
Military Specific Duty Status
Time frame: Baseline Visit, Week 1-12 Visits, and Final Follow-up Visit (up to 16 weeks after Baseline Visit)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Joint Base Lewis McChord, Washington
Collaborators
Uniformed Services University of the Health Sciences, Madigan Army Medical Center
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 5, 2026 · Source of record for eligibility and locations