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
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
Brief Title
A Randomized Study of Three Medication Regimens for Acute Low Back Pain
Categories
Completion Date
Completion Date Type
Actual
Conditions
Acute Low Back Pain
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
* 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
Inclusion Criteria
Inclusion Criteria:
* Non-radicular, non-traumatic low back pain of no more than 2 weeks duration
* Non-radicular, non-traumatic low back pain of no more than 2 weeks duration
Gender
All
Gender Based
false
Keywords
low back pain
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
64 Years
Minimum Age
21 Years
NCT Id
NCT01587274
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
11-10-379
Overall Status
Completed
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Actual
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.
Primary Outcomes
Outcome Description
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.
Outcome Measure
Change in Functional Disability as Measured by the Roland Morris Disability Questionnaire
Outcome Time Frame
Baseline and one week after discharge from emergency department
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Maximum Age Number (converted to Years and rounded down)
64
Minimum Age Number (converted to Years and rounded down)
21
Investigators
Investigator Type
Principal Investigator
Investigator Name
Benjamin Friedman
Investigator Email
befriedm@montefiore.org
Investigator Phone
646-265-6415