Orphenadrine and Methocarbamol for LBP

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-05-31

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

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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

Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type PLACEBO_COMPARATOR

Naproxen

Intervention Type DRUG

Naproxen 500mg PO BID x 7 days

Placebo

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

Orphenadrine

Intervention Type DRUG

Orphenadrine 100mg PO BID x 7 days

Naproxen

Intervention Type DRUG

Naproxen 500mg PO BID x 7 days

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

Group Type ACTIVE_COMPARATOR

Methocarbamol

Intervention Type DRUG

Methocarbamol 750mg 1-2 tabs po TID x 7 days

Naproxen

Intervention Type DRUG

Naproxen 500mg PO BID x 7 days

Interventions

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Orphenadrine

Orphenadrine 100mg PO BID x 7 days

Intervention Type DRUG

Methocarbamol

Methocarbamol 750mg 1-2 tabs po TID x 7 days

Intervention Type DRUG

Naproxen

Naproxen 500mg PO BID x 7 days

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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anticholinergic drug Muscle relaxant nonsteroidal anti-inflammatory drug

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