A Randomized Study of Three Medication Regimens for Acute Low Back Pain

NCT ID: NCT01587274

Last Updated: 2018-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 323 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2014-12-31

Brief 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 investigators propose a clinical trial to evaluate whether combining muscle relaxants or opioids with NSAIDs is more effective than NSAID monotherapy for the treatment of non-traumatic, non-radicular low back pain. Specifically, the investigators will evaluate three distinct hypotheses:

1. The combination of naproxen + cyclobenzaprine will provide greater relief of LBP than naproxen alone seven days after an ED visit, as measured by the Roland Morris low back pain functional disability scale

2. The combination of naproxen + oxycodone/ acetaminophen will provide greater relief of LBP than naproxen alone seven days after an ED visit, as measured by the Roland Morris low back pain functional disability scale

3. The combination of naproxen + oxycodone/ acetaminophen will provide greater relief of LBP than naproxen + cyclobenzaprine seven days after an ED visit, as measured by the Roland Morris low back pain functional disability scale

Conditions

Acute Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Opioid

Naproxen + opioid

Group Type: ACTIVE_COMPARATOR

Naproxen

Intervention Type: DRUG

Naproxen 500mg twice/ day x 10 days

Oxycodone/ acetaminophen

Intervention Type: DRUG

Oxycodone 5-10mg/ Acetaminophen 325-650 mg three times/ day x 10 days

Skeletal muscle relaxant

Naproxen + skeletal muscle relaxant

Group Type: ACTIVE_COMPARATOR

Naproxen

Intervention Type: DRUG

Naproxen 500mg twice/ day x 10 days

Cyclobenzaprine

Intervention Type: DRUG

Cyclobenzaprine 5-10mg three times/ day x 10 days

Naproxen alone

Naproxen + placebo

Group Type: ACTIVE_COMPARATOR

Naproxen

Intervention Type: DRUG

Naproxen 500mg twice/ day x 10 days

Interventions

Naproxen

Naproxen 500mg twice/ day x 10 days

Intervention Type: DRUG

Cyclobenzaprine

Cyclobenzaprine 5-10mg three times/ day x 10 days

Intervention Type: DRUG

Oxycodone/ acetaminophen

Oxycodone 5-10mg/ Acetaminophen 325-650 mg three times/ day x 10 days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Non-radicular, non-traumatic low back pain of no more than 2 weeks duration

Exclusion Criteria

• Back pain longer than 2 weeks
• Prior to the acute attack of low back pain, back pain once per month or more frequently
• Prior to the acute attack of low back pain, daily or near daily use of pain medication

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Benjamin W. Friedman, MD

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Montefiore Medical Center

The Bronx, New York, United States

Countries

United States

References

Friedman BW, Dym AA, Davitt M, Holden L, Solorzano C, Esses D, Bijur PE, Gallagher EJ. Naproxen With Cyclobenzaprine, Oxycodone/Acetaminophen, or Placebo for Treating Acute Low Back Pain: A Randomized Clinical Trial. JAMA. 2015 Oct 20;314(15):1572-80. doi: 10.1001/jama.2015.13043.

Reference Type: DERIVED

PMID: 26501533 (View on PubMed)

Other Identifiers

11-10-379

Identifier Type: -

Identifier Source: org_study_id