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NCT01587274 · ClinicalTrials.gov registry record · Phase 4
A Randomized Study of Three Medication Regimens for Acute Low Back Pain
A Phase 4 study, sponsored by Montefiore Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 323
- Enrollment target
NCT01587274 is a Phase 4 study that has completed, run by Montefiore Medical Center. The registered enrollment target is 323 participants.
The verdict
NCT01587274, a Phase 4 study, has completed, sponsored by Montefiore Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 323 participants
- Enrollment target
Study Summary
Low back pain causes 2.4% of visits to US emergency departments (ED) resulting in 2.7 million visits annually. In a general low back pain (LBP) population, prognosis is poor. About 50% of patients who visited general practitioners with new onset musculoskeletal LBP report persistent pain and functional disability three months after the index visit. Outcomes are similarly poor for the population of patients forced to use an ED for management of their LBP. In an observational study of patients with non-traumatic LBP recently completed at the PI's institution, patients were contacted one week after ED discharge: 70% reported persistent back-pain related functional impairment, 59% reported moderate or severe LBP, and 69% reported analgesic use within the previous 24 hours. Three months after the ED visit, 48% reported functional impairment, 42% reported moderate or severe pain, and 46% reported analgesic use within the previous 24 hours. A variety of evidence-based medications are available to treat LBP. Non-steroidal anti-inflammatory drugs (NSAID) are more efficacious than placebo with regard to pain relief, global improvement, and requirement of analgesic medication. Skeletal muscle-relaxants too are effective for short-term pain relief and global efficacy. Opioids are commonly used for moderate or severe acute LBP,(9) though high-quality evidence supporting this practice is lacking. Treatment of LBP with multiple concurrent medications is common in the ED setting. Emergency physicians often prescribe NSAIDs, skeletal muscle relaxants, and opioids in combination. Several clinical trials have compared combination therapy with NSAIDS+ skeletal muscle relaxants to monotherapy with just one of these agents. These trials have reported heterogeneous results. The combination of opioids + NSAIDS has not been evaluated experimentally in patients with acute LBP. Given the poor pain and functional outcomes that persist beyond an ED visit for musculoskeletal LBP, the investig
Interventions
- DRUG Cyclobenzaprine
- DRUG Naproxen
- DRUG Oxycodone/ acetaminophen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 323 participants |
| Start Date | 2012-04 |
| Est. Completion | 2014-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01587274
The ClinicalTrials.gov registry entry for NCT01587274 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 323 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Montefiore Medical Center, which has 345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Cyclobenzaprine is the first listed.
NCT01587274 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01587274 about?
NCT01587274 is a clinical study titled "A Randomized Study of Three Medication Regimens for Acute Low Back Pain". Low back pain causes 2.4% of visits to US emergency departments (ED) resulting in 2.7 million visits annually. In a general low back pain (LBP) population, prognosis is poor. About 50% of patients who visited general practitioners with new onset musculoskeletal LBP report persistent pain and functio...
What is the current status of trial NCT01587274?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 323 participants. The study started on 2012-04. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01587274?
The interventions under investigation include: Cyclobenzaprine (DRUG), Naproxen (DRUG), Oxycodone/ acetaminophen (DRUG).
Who is sponsoring clinical trial NCT01587274?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
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