Orphenadrine and Methocarbamol for LBP

Study Overview
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Brief Summary
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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
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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

Official Title
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Methocarbamol and Orphenadrine for Acute, Non-traumatic, Non-radicular Low Back Pain: A Randomized, Placebo Controlled, 3-armed Study

Conditions
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Low Back Pain

Intervention / Treatment
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* Drug: Orphenadrine
* Drug: Methocarbamol
* Drug: Naproxen
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>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 | Drug: Naproxen<br>* Naproxen 500mg PO BID x 7 days<br>* Other names: nonsteroidal anti-inflammatory drug;Drug: Placebo<br>* 1/2 of placebo packages will be dosed to match methocarbamol: 1-2 tabs po TID x 7days 1/2 of placebo packages will be dosed to match orphenadrine: 1 tab PO BID x 7 days<br>|
| Active Comparator: Orphenadrine<br>Naproxen 500mg, orally twice per day + orphenadrine 100mg, orally twice per day for 10 days Naproxen 500mg po BID x 10 days #20 + Orphenadrine | Drug: Orphenadrine<br>* Orphenadrine 100mg PO BID x 7 days<br>* Other names: anticholinergic drug;Drug: Naproxen<br>* Naproxen 500mg PO BID x 7 days<br>* Other names: nonsteroidal anti-inflammatory drug;|
| Active Comparator: Methocarbamol<br>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 | Drug: Methocarbamol<br>* Methocarbamol 750mg 1-2 tabs po TID x 7 days<br>* Other names: Muscle relaxant;Drug: Naproxen<br>* Naproxen 500mg PO BID x 7 days<br>* Other names: nonsteroidal anti-inflammatory drug;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Impairment as Measured on the Roland Morris Disability Questionnaire | 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. | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cases of Moderate or Severe LBP | Participants with moderate to severe low back pain after treatment as report on the following ordinal scale: severe, moderate, mild, or none | 1 week | 
| Medications--Patient Self Report of Medication Use | Participants still using medication such as analgesics for LBP after treatment | 1 week | 
| Patient Satisfaction With Treatment | 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. | 1 week |