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Orphenadrine and Methocarbamol for LBP

This study is currently recruiting participants.
Verified September 2016 by Montefiore Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02665286
First Posted: January 27, 2016
Last Update Posted: September 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Montefiore Medical Center
  Purpose
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

Condition Intervention Phase
Low Back Pain Drug: Orphenadrine Drug: Methocarbamol Drug: Naproxen Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Methocarbamol and Orphenadrine for Acute, Non-traumatic, Non-radicular Low Back Pain: A Randomized, Placebo Controlled, 3-armed Study

Resource links provided by NLM:


Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • Functional impairment as measured on the Roland Morris Disability Questionnaire [ Time Frame: 1 week ]
    Improvement in Roland Morris Disability Questionnaire between baseline and 1 week


Secondary Outcome Measures:
  • Low back pain as report on the following ordinal scale: severe, moderate, mild, or none [ Time Frame: 1 week ]
    Moderate or severe LBP

  • Medications--Patient self report of medication use [ Time Frame: 1 week ]
    Use of medication for LBP

  • Roland Morris Disability Questionnaire--a 24 item low back pain instrument [ Time Frame: 3 months ]
    Score on Roland Morris Disability Questionnaire

  • Desirability--This is a patient-centered outcome that allows each individual to determine the desirability of the intervention [ Time Frame: 1 week ]
    Participant response to the following question: Do you want the same medication combination during a subsequent episode of LBP


Estimated Enrollment: 240
Study Start Date: March 2016
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Naproxen 500mg po BID x 10 days #20 + Placebo
Drug: Naproxen
Naproxen 500mg PO BID x 7 days
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 po BID x 10 days #20 + Orphenadrine
Drug: Orphenadrine
Orphenadrine 100mg PO BID x 7 days
Drug: Naproxen
Naproxen 500mg PO BID x 7 days
Active Comparator: Methocarbamol
Naproxen 500mg po BID x 10 days #20 + Methocarbamol
Drug: Methocarbamol
Methocarbamol 750mg 1-2 tabs po TID x 7 days
Drug: Naproxen
Naproxen 500mg PO BID x 7 days

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02665286


Contacts
Contact: Belinda Tavarez 718-920-6626 btavarez@montefiore.org

Locations
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Belinda Tavarez    718-920-6626    btavarez@montefiore.org   
Principal Investigator: Benjamin W Friedman, MD, MS         
Sponsors and Collaborators
Montefiore Medical Center
Investigators
Principal Investigator: Benjamin W Friedman, MD, MS Albert Einstein College of Medicine, Inc.
  More Information

Responsible Party: Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT02665286     History of Changes
Other Study ID Numbers: 2015-5903
First Submitted: January 15, 2016
First Posted: January 27, 2016
Last Update Posted: September 7, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Naproxen
Orphenadrine
Methocarbamol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiparkinson Agents
Anti-Dyskinesia Agents
Muscle Relaxants, Central
Neuromuscular Agents
Parasympatholytics
Autonomic Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents