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NCT01726803 · ClinicalTrials.gov registry record · NA
Comparative Effectiveness of Acute Low Back Pain Management
A NA study, sponsored by University of Utah.
- Completed
- Registry status
- NA
- Development phase
- 220
- Enrollment target
NCT01726803 is a NA study that has completed, run by University of Utah. The registered enrollment target is 220 participants.
The verdict
NCT01726803, a NA study, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- NA
- Development phase
- 220 participants
- Enrollment target
Study Summary
Current practice guidelines for patients with acute low back pain (LBP) recommend a stepped care approach with initial treatment of education and advice to remain active. Referral to physical therapy is considered only when patients fail to recover after a few weeks. Recent research has led to the identification a subgroup of patients likely to experience rapid, pronounced, and sustained decreases in disability and pain with a brief manipulation and exercise intervention, suggesting it may be more cost-effective to manage this sub-group with early referral to physical therapy instead of the usual care approach. The integration of this evidence into routine practice has not been evaluated. We will assess the outcomes of integrating this evidence into the management of patients with low back pain. The study is a randomized trial, comparing management with early manipulation with the current care process model. Patients fitting the inclusion criteria will be randomized into one of two groups. One group will be managed with the current care process model. The other group will be managed consistent with the decision rule recommending early referral for a brief manipulation and exercise intervention during the first 4 weeks. Patients will be followed over 1 year. Outcomes will include measures of disability, pain, satisfaction, and direct medical costs. The study will examine the costs and effectiveness of integrating the alternative care model into practice.
Interventions
- OTHER Usual Care
- OTHER Early Physical Therapy with Usual Care
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2011-04 |
| Est. Completion | 2014-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01726803
The ClinicalTrials.gov registry entry for NCT01726803 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 220 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Usual Care is the first listed.
NCT01726803 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01726803 about?
NCT01726803 is a clinical study titled "Comparative Effectiveness of Acute Low Back Pain Management". Current practice guidelines for patients with acute low back pain (LBP) recommend a stepped care approach with initial treatment of education and advice to remain active. Referral to physical therapy is considered only when patients fail to recover after a few weeks. Recent research has led to the i...
What is the current status of trial NCT01726803?
This trial is currently completed. It is a NA study. The enrollment target is 220 participants. The study started on 2011-04. Estimated completion is 2014-11.
What interventions are being tested in trial NCT01726803?
The interventions under investigation include: Usual Care (OTHER), Early Physical Therapy with Usual Care (OTHER).
Who is sponsoring clinical trial NCT01726803?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
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