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

This study is currently recruiting participants.
Verified March 2014 by Montefiore Medical Center
Sponsor:
Information provided by (Responsible Party):
Benjamin Friedman, Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT01587274
First received: April 26, 2012
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

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

Condition Intervention Phase
Acute Low Back Pain
Drug: Naproxen
Drug: Cyclobenzaprine
Drug: Oxycodone/ acetaminophen
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Three-armed Comparative Effectiveness Study of Various Medications for Musculoskeletal Low Back Pain: Defining the Added Benefit of Muscle Relaxants and Opioids.

Resource links provided by NLM:


Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • Roland Morris low back pain functional disability scale [ Time Frame: 7 days after ER discharge ] [ Designated as safety issue: No ]
    This questionnaire has 24 distinct questions which assess the impact of the low back pain on a patient's functionality


Estimated Enrollment: 323
Study Start Date: April 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Opioid
Naproxen + opioid
Drug: Naproxen
Naproxen 500mg twice/ day x 10 days
Drug: Oxycodone/ acetaminophen
Oxycodone 5-10mg/ Acetaminophen 325-650 mg three times/ day x 10 days
Active Comparator: Skeletal muscle relaxant
Naproxen + skeletal muscle relaxant
Drug: Naproxen
Naproxen 500mg twice/ day x 10 days
Drug: Cyclobenzaprine
Cyclobenzaprine 5-10mg three times/ day x 10 days
Active Comparator: Naproxen alone
Naproxen + placebo
Drug: Naproxen
Naproxen 500mg twice/ day x 10 days

  Eligibility

Ages Eligible for Study:   21 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01587274

Locations
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Benjamin W Friedman, MD, MS    718-920-6626    befriedm@montefiore.org   
Sponsors and Collaborators
Montefiore Medical Center
  More Information

No publications provided

Responsible Party: Benjamin Friedman, Associate professor, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT01587274     History of Changes
Other Study ID Numbers: Low Back Pain RCT
Study First Received: April 26, 2012
Last Updated: March 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Montefiore Medical Center:
low back pain

Additional relevant MeSH terms:
Muscle Relaxants, Central
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Acetaminophen
Naproxen
Amitriptyline
Acetaminophen, hydrocodone drug combination
Oxycodone
Cyclobenzaprine
Neuromuscular Agents
Analgesics, Opioid
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014