Phase 4
N=240
Orphenadrine and Methocarbamol for LBP
Low Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT02665286 ↗Enrolled (actual)
240
Serious AEs
0.0%
Results posted
Jun 2018
Primary outcome: Primary: Functional Impairment as Measured on the Roland Morris Disability Questionnaire — 10.9; 9.4; 8.1 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Orphenadrine (Drug); Methocarbamol (Drug); Naproxen (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Montefiore Medical Center
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Functional Impairment as Measured on the Roland Morris Disability Questionnaire |
10.9; 9.4; 8.1 | — |
| SECONDARY Cases of Moderate or Severe LBP |
34; 26; 31 | — |
| SECONDARY Medications--Patient Self Report of Medication Use |
42; 40; 50 | — |
| SECONDARY Patient Satisfaction With Treatment |
51; 53; 51 | — |
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
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Medication allergies or contra-indications
- Not available for follow-up
- Chronic pain syndrome
Data sourced from ClinicalTrials.gov (NCT02665286). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.