Medical Massage Therapy for Sub-Acute Lower Back Pain
This study is looking at whether Medical Massage Therapy (MMT) can help active-duty service members with sub-acute lower back pain (pain lasting 1-3 months). Researchers want to see if MMT, when added to regular care from a healthcare provider, can shorten the time people are on "Medically Restricted Duty Days" (MRDD). They also want to see if MMT can reduce pain and how often people need to use healthcare services. You might be able to join if you are an active-duty service member between 18 and 64 years old with sub-acute lower back pain. The study will measure your pain and how well you can do daily activities to see if the treatment is successful. The current status of this study is unclear.
- Study design
- This is an interventional study planning to enroll 220 participants. It compares Medical Massage Therapy plus provider-directed care to provider-directed care alone.
- What's involved
- Participants will have visits at baseline, week 1, week 6, week 12, and a final follow-up visit up to 16 weeks after the start of the study. You will receive either medical massage therapy or provider-directed care.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 16 weeks after their baseline visit.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Investigating Medical Massage Therapy for Patients With Sub-Acute Lower Back Pain
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Ghena G. Grinshpun, PhD, MBA, MSF, PMP · PRINCIPAL_INVESTIGATOR · Madigan Army Medical Center
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Modified Oswestry Low Back Pain Disability Index (M-ODI)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 DataWeek 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)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)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)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)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)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 HistoryWeek 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 StatusBaseline Visit, Week 1-12 Visits, and Final Follow-up Visit (up to 16 weeks after Baseline Visit)