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NCT04172038 · ClinicalTrials.gov registry record · NA
SMART Stepped Care Management for Low Back Pain in the Military Health System
A NA study of Chronic Pain and Low Back Pain, sponsored by Brooke Army Medical Center.
- Active
- Registry status
- NA
- Development phase
- 850
- Enrollment target
- 4
- Study locations
NCT04172038: Active NA study of Chronic Pain and Low Back Pain, sponsored by Brooke Army Medical Center.
NCT04172038 is a NA study of Chronic Pain and Low Back Pain that is active but no longer recruiting, run by Brooke Army Medical Center. The registered enrollment target is 850 participants, above the 770-participant average among 301 other Chronic Pain trials with a reported enrollment target (10% higher). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04172038, a NA study of Chronic Pain and Low Back Pain, is active but no longer recruiting, sponsored by Brooke Army Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 850 participants
- Enrollment target
- 4
- Study locations
Study Summary
This study will be sequential, randomization trial where patients with chronic low back pain are initially randomized to receive 1 of 2 treatments (physical therapy OR Move 2 Health). This will be Phase I of the study intervention. Patients who do not respond to treatment after 6 weeks will undergo a subsequent sequential randomization. This will be Phase II of the study intervention. Patients in Phase II will be randomized to receive 1 of 2 treatments (addition of physical therapy or Move 2 Health, whichever one they did not receive OR the MORE Mindfulness intervention). Patients will be followed for 1 year after enrollment.
Primary Outcome
Computer-adapted assessment using a 44-item bank measuring the self-reported consequences of pain on relevant aspects of life including impact on social, emotional, cognitive, physical and recreational activities. All Patient-Reported Outcomes Measurement Information System (PROMIS®) scores are reported on a T-score metric with a score of 50 points aligning with the general population mean and a standard deviation of 10. Higher scores indicate greater pain interference.
Conditions Studied
Interventions
- BEHAVIORAL Physical Therapy
- BEHAVIORAL Move 2 Health (M2H)
- BEHAVIORAL MORE Mindfulness
Study Locations (4)
Texas
- Brooke Army Medical Center - San Antonio
- Wilford Hall Ambulatory Surgical Center - San Antonio
Hawaii
- Desmond Doss Health Clinic - Schofield Barracks
Washington
- Madigan Army Medical Center - Tacoma
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 850 participants |
| Start Date | 2019-12-09 |
| Est. Completion | 2025-07 |
| Phase | NA |
What the registry record for NCT04172038 still lists
NCT04172038 is an interventional study that assigns participants to a tested intervention. The registered 850 participants enrollment target is mid-sized for trials with a published cap, above the 770-participant average among 301 other Chronic Pain trials with a reported enrollment target (10% higher).
The record links to 4 conditions, with Chronic Pain appearing as the primary indexed condition, and to 3 interventions - of which Physical Therapy is the first listed.
NCT04172038 reports a single indexed study location in Texas, Hawaii, Washington.
Frequently Asked Questions
What is clinical trial NCT04172038 about?
NCT04172038 is a clinical study titled "SMART Stepped Care Management for Low Back Pain in the Military Health System". This study will be sequential, randomization trial where patients with chronic low back pain are initially randomized to receive 1 of 2 treatments (physical therapy OR Move 2 Health). This will be Phase I of the study intervention. Patients who do not respond to treatment after 6 weeks will undergo ...
What is the current status of trial NCT04172038?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 850 participants. The study started on 2019-12-09. Estimated completion is 2025-07.
What conditions does trial NCT04172038 study?
This clinical trial studies the following conditions: Chronic Pain, Low Back Pain, Veterans, Military Personnel.
What interventions are being tested in trial NCT04172038?
The interventions under investigation include: Physical Therapy (BEHAVIORAL), Move 2 Health (M2H) (BEHAVIORAL), MORE Mindfulness (BEHAVIORAL).
Who is sponsoring clinical trial NCT04172038?
This trial is sponsored by Brooke Army Medical Center, which has 54 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04172038 being conducted?
This trial has 4 study locations across Hawaii, Texas, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Pain
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04172038's enrollment target sits among peer trials
850 12th of 301 higher than 290 of 301 other Chronic Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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