Investigating Medical Massage Therapy for Patients With Sub-Acute Lower Back Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorThe Geneva Foundation
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Medical Massage Therapy
Procedure/SurgeryMassage and educational treatment provided by a licensed massage therapist.
Provider Directed Care
Other interventionProvider directed care (i.e. Physical Therapy)
Treatment groups
220 Participants
are divided into 2 treatment groupsGroup A: Group #1Placebo comparator 1 intervention
Group B: Group #2Active comparator 2 interventions
Trial outcomes
Primary outcomes
1
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.
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)2
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.
Time frame
Week 1-12 Visits, and Final Follow-up Visit (up to 16 weeks after Baseline Visit)3
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.
Time frame
Baseline Visit, Week 1-12 Visits, and Final Follow-up Visit (up to 16 weeks after Baseline Visit)4
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.
Time frame
Baseline Visit, Week 1-12 Visits, and Final Follow-up Visit (up to 16 weeks after Baseline Visit)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
The Geneva Foundation
Lead sponsor
Uniformed Services University of the Health Sciences
Collaborator
Madigan Army Medical Center
Collaborator
Source ClinicalTrials.gov