Orphenadrine and Methocarbamol for LBP

Montefiore Medical Center240 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

240

Conditions

Low Back Pain

Interventions

OrphenadrineDRUG

Orphenadrine 100mg PO BID x 7 days

MethocarbamolDRUG

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

NaproxenDRUG

Naproxen 500mg PO BID x 7 days

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 69 Years

Medical Language ↔ Plain English

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

Locations (1)

Montefiore Medical Center

The Bronx, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: 1 week

Secondary Outcomes

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

Time frame: 1 week

Medications--Patient Self Report of Medication Use

Participants still using medication such as analgesics for LBP after treatment

Time frame: 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.

Time frame: 1 week

Data from ClinicalTrials.gov

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