Orphenadrine and Methocarbamol for LBP
- Conditions
- Low Back Pain
- Interventions
- Registration Number
- NCT02665286
- Lead Sponsor
- Montefiore Medical Center
- Brief Summary
Low back pain is a common cause of visit to emergency department. It is not clear if skeletal muscle relaxants are of benefit for patients with acute low back pain. This is a randomized study to determine if skeletal muscle relaxants, when combined with naproxen, improve outcomes more than naproxen alone
- Detailed Description
Patients with acute, non-traumatic, non-radicular low back pain will be enrolled at the time of discharge from the emergency department. Participants will be followed by telephone one week and 3 months after the ED visit
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 240
- LBP duration <= 2 weeks
- No trauma to low back within previous month
- No radicular symptoms
- No history of low back pain or history of only infrequent episodes
- Medication allergies or contra-indications
- Not available for follow-up
- Chronic pain syndrome
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Naproxen 500mg tablets taken twice per day + placebo. Placebo dose will be either 1 capsule orally twice per day or 1 or 2 capsules orally, thrice per day Naproxen 500mg po BID x 10 days #20 + Placebo Placebo Naproxen Naproxen 500mg tablets taken twice per day + placebo. Placebo dose will be either 1 capsule orally twice per day or 1 or 2 capsules orally, thrice per day Naproxen 500mg po BID x 10 days #20 + Placebo Orphenadrine Orphenadrine Naproxen 500mg, orally twice per day + orphenadrine 100mg, orally twice per day for 10 days Naproxen 500mg po BID x 10 days #20 + Orphenadrine Orphenadrine Naproxen Naproxen 500mg, orally twice per day + orphenadrine 100mg, orally twice per day for 10 days Naproxen 500mg po BID x 10 days #20 + Orphenadrine Methocarbamol Naproxen Naproxen 500mg tablets, orally twice per day + methocarbamol 750mg, orally as 1 or 2 tabs, thrice per day Naproxen 500mg po BID x 10 days #20 + Methocarbamol Methocarbamol Methocarbamol Naproxen 500mg tablets, orally twice per day + methocarbamol 750mg, orally as 1 or 2 tabs, thrice per day Naproxen 500mg po BID x 10 days #20 + Methocarbamol
- Primary Outcome Measures
Name Time Method Functional Impairment as Measured on the Roland Morris Disability Questionnaire 1 week Change in Roland Morris Disability Questionnaire between baseline and 1 week.
The low back pain functional disability scale is the RMDQ. The RMDQ is a 24-item low back pain functional scale recommended for use in low back pain research.Higher scores signify greater low back-related functional impairment.0= no functional impairment, 24= severe functional impairment.
- Secondary Outcome Measures
Name Time Method Cases of Moderate or Severe LBP 1 week Participants with moderate to severe low back pain after treatment as report on the following ordinal scale: severe, moderate, mild, or none
Medications--Patient Self Report of Medication Use 1 week Participants still using medication such as analgesics for LBP after treatment
Patient Satisfaction With Treatment 1 week The number of participants with affirmative response to the following question: Do you want the same medication combination during a subsequent episode of LBP. This is a patient-centered outcome that allows each individual to determine the desirability of the intervention.
Trial Locations
- Locations (1)
Montefiore Medical Center
🇺🇸Bronx, New York, United States