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

NCT01587274 | Completed Phase 4 Results DMC

• 1 other identifier: 11-10-379
• Study Type: interventional
• Target: 323
• Locations: 1 country
• Sites: 1

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. 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. 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. 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

Keywords

low back pain

Outcome Measures

Primary Outcomes (1)

• Change in Functional Disability as Measured by the Roland Morris Disability Questionnaire

  The Roland Morris Disability Questionnaire (RMDQ) is a 24 item instrument that evaluates the impact of low back pain on one's daily life. It is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. Each question can be answered as either a "yes" or "no". The score ranges from 0 to 24 where a higher score reflects greater impairment and, therefore, worsening in the quality of life. The change in RMDQ is obtained by subtracting the RMDQ score at one week after discharge from the baseline score.

  Baseline and one week after discharge from emergency department

Study Arms (3)

Opioid

ACTIVE COMPARATOR

Naproxen + opioid

Drug: Naproxen; Drug: Oxycodone/ acetaminophen

Skeletal muscle relaxant

ACTIVE COMPARATOR

Naproxen + skeletal muscle relaxant

Drug: Naproxen; Drug: Cyclobenzaprine

Naproxen alone

ACTIVE COMPARATOR

Naproxen + placebo

Drug: Naproxen

Interventions

Naproxen DRUG

Naproxen 500mg twice/ day x 10 days

Naproxen alone; Opioid; Skeletal muscle relaxant

Cyclobenzaprine DRUG

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

Skeletal muscle relaxant

Oxycodone/ acetaminophen DRUG

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

Opioid

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Publications (1)

• 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.

  PMID: 26501533 DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Naproxen; cyclobenzaprine; oxycodone-acetaminophen

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Benjamin W. Friedman, MD
• Organization: Montefiore Health

befriedm@montefiore.org

7189206626

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: April 26, 2012
• First Posted: April 30, 2012
• Study Start: April 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2014
• Last Updated: July 31, 2018
• Results First Posted: July 31, 2018

Record last verified: 2018-07

Locations

US (1)