Acute Low Back Pain
Conditions
Keywords
low back pain
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
Interventions
DRUGNaproxen
Naproxen 500mg twice/ day x 10 days
DRUGCyclobenzaprine
Cyclobenzaprine 5-10mg three times/ day x 10 days
DRUGOxycodone/ acetaminophen
Oxycodone 5-10mg/ Acetaminophen 325-650 mg three times/ day x 10 days
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Functional Disability as Measured by the Roland Morris Disability Questionnaire | Baseline and one week after discharge from emergency department | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Opioid Naproxen + opioid
Naproxen: Naproxen 500mg twice/ day x 10 days
Oxycodone/ acetaminophen: Oxycodone 5-10mg/ Acetaminophen 325-650 mg three times/ day x 10 days | 108 |
| Skeletal Muscle Relaxant Naproxen + skeletal muscle relaxant
Naproxen: Naproxen 500mg twice/ day x 10 days
Cyclobenzaprine: Cyclobenzaprine 5-10mg three times/ day x 10 days | 108 |
| Naproxen Alone Naproxen + placebo
Naproxen: Naproxen 500mg twice/ day x 10 days | 107 |
| Total | 323 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 5 | 3 |
Baseline characteristics
| Characteristic | Opioid | Skeletal Muscle Relaxant | Naproxen Alone | Total |
|---|---|---|---|---|
| Age, Continuous | 39 years STANDARD_DEVIATION 11 | 38 years STANDARD_DEVIATION 11 | 39 years STANDARD_DEVIATION 11 | 39 years STANDARD_DEVIATION 11 |
| Pre-existing functional impairment as measured by the Roland Morris Disability Questionnaire | 20 units on a scale | 19 units on a scale | 20 units on a scale | 20 units on a scale |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment United States | 108 participants | 108 participants | 107 participants | 323 participants |
| Sex: Female, Male Female | 60 Participants | 45 Participants | 53 Participants | 158 Participants |
| Sex: Female, Male Male | 48 Participants | 63 Participants | 54 Participants | 165 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 43 / 108 | 36 / 108 | 22 / 107 |
| serious Total, serious adverse events | 0 / 108 | 0 / 108 | 0 / 107 |
Outcome results
Primary
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.
Time frame: Baseline and one week after discharge from emergency department
Population: Multiple imputation used to account for participants lost to follow-up
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Opioid | Change in Functional Disability as Measured by the Roland Morris Disability Questionnaire | 5 units on a scale |
| Skeletal Muscle Relaxant | Change in Functional Disability as Measured by the Roland Morris Disability Questionnaire | 4 units on a scale |
| Naproxen Alone | Change in Functional Disability as Measured by the Roland Morris Disability Questionnaire | 7 units on a scale |