Orphenadrine and Methocarbamol for LBP

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

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

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Drug: Naproxen; Drug: Placebo; Drug: Orphenadrine; Drug: Methocarbamol

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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	Drug: Naproxen; Naproxen 500mg PO BID x 7 days; Other Names: nonsteroidal anti-inflammatory drug; 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
Active Comparator: 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	Drug: Naproxen; Naproxen 500mg PO BID x 7 days; Other Names: nonsteroidal anti-inflammatory drug; Drug: Orphenadrine; Orphenadrine 100mg PO BID x 7 days; Other Names: anticholinergic drug
Active Comparator: 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	Drug: Naproxen; Naproxen 500mg PO BID x 7 days; Other Names: nonsteroidal anti-inflammatory drug; Drug: Methocarbamol; Methocarbamol 750mg 1-2 tabs po TID x 7 days; Other Names: Muscle relaxant

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Investigators: Principal Investigator: Benjamin W Friedman, MD, MS, Albert Einstein College of Medicine

Publications and helpful links

General Publications

• Friedman BW, Cisewski D, Irizarry E, Davitt M, Solorzano C, Nassery A, Pearlman S, White D, Gallagher EJ. A Randomized, Double-Blind, Placebo-Controlled Trial of Naproxen With or Without Orphenadrine or Methocarbamol for Acute Low Back Pain. Ann Emerg Med. 2018 Mar;71(3):348-356.e5. doi: 10.1016/j.annemergmed.2017.09.031. Epub 2017 Oct 28.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: January 15, 2016
• First Submitted That Met QC Criteria: January 22, 2016
• First Posted (Estimate): January 27, 2016

Study Record Updates

• Last Update Posted (Actual): June 26, 2018
• Last Update Submitted That Met QC Criteria: May 29, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Neuromuscular Agents; Gout Suppressants; Muscle Relaxants, Central; Antiparkinson Agents; Anti-Dyskinesia Agents; Cytochrome P-450 CYP2B6 Inhibitors; Anti-Inflammatory Agents; Orphenadrine; Anti-Inflammatory Agents, Non-Steroidal; Naproxen; Cholinergic Antagonists; Methocarbamol
• Other Study ID Numbers: 2015-5903

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No