Orphenadrine and Methocarbamol for LBP

NCT02665286 | Completed Phase 4 Results DMC

• 1 other identifier: 2015-5903
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Cases of Moderate or Severe LBP

  1 week

• Medications--Patient Self Report of Medication Use

  1 week

• Patient Satisfaction With Treatment

  1 week

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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; Drug: Placebo

Orphenadrine

ACTIVE COMPARATOR

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: Orphenadrine; Drug: Naproxen

Methocarbamol

ACTIVE COMPARATOR

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: Methocarbamol; Drug: Naproxen

Interventions

Orphenadrine DRUG

Orphenadrine 100mg PO BID x 7 days

Also known as: anticholinergic drug

Orphenadrine

Methocarbamol DRUG

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

Also known as: Muscle relaxant

Methocarbamol

Naproxen DRUG

Naproxen 500mg PO BID x 7 days

Also known as: nonsteroidal anti-inflammatory drug

Methocarbamol; Orphenadrine; Placebo

Placebo 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

Placebo

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Medication allergies or contra-indications
• Not available for follow-up
• Chronic pain syndrome

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Publications (1)

• 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.

  PMID: 29089169 DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Orphenadrine; Cholinergic Antagonists; Methocarbamol; Naproxen; Anti-Inflammatory Agents, Non-Steroidal

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethylamines; Amines; Organic Chemicals; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Phenylcarbamates; Carbamates; Acids, Acyclic; Carboxylic Acids; Guaifenesin; Guaiacol; Methyl Ethers; Ethers; Phenyl Ethers; Phenols; Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents

Results Point of Contact

• Title: Benjamin W. Friedman, MD, MS
• Organization: Montefiore Medical Center

befriedm@montefiore.org

(718)920-6266

Study Officials

• Benjamin W Friedman, MD, MS

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 15, 2016
• First Posted: January 27, 2016
• Study Start: March 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: May 1, 2017
• Last Updated: June 26, 2018
• Results First Posted: June 26, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)