Orphenadrine and Methocarbamol for LBP

Montefiore Medicine Academic Health System

Status and phase: Completed; Phase 4

Conditions: Low Back Pain

Treatments: Drug: Placebo; Drug: Methocarbamol; Drug: Naproxen; Drug: Orphenadrine

Study type: Interventional

Funder types: Other

Identifiers

NCT02665286

2015-5903

Details and patient eligibility

About

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

Full 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

Enrollment: 240 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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240 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: Naproxen

Orphenadrine

Active Comparator group

Description:

Naproxen 500mg, orally twice per day + orphenadrine 100mg, orally twice per day for 10 days Naproxen 500mg po BID x 10 days #20 + Orphenadrine

Treatment:

Drug: Orphenadrine

Drug: Naproxen

Methocarbamol

Active Comparator group

Description:

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

Treatment:

Drug: Naproxen

Drug: Methocarbamol