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Orphenadrine and Methocarbamol for LBP

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ClinicalTrials.gov Identifier: NCT02665286
Recruitment Status : Completed
First Posted : January 27, 2016
Results First Posted : June 26, 2018
Last Update Posted : June 26, 2018
Sponsor:
Information provided by (Responsible Party):
Benjamin W. Friedman, MD, Montefiore Medical Center

Study Description
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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

Condition or disease Intervention/treatment Phase
Low Back Pain Drug: Orphenadrine Drug: Methocarbamol Drug: Naproxen Drug: Placebo Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
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
Actual Study Start Date : March 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arms and Interventions
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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 Name: 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: Orphenadrine
Orphenadrine 100mg PO BID x 7 days
Other Name: anticholinergic drug

Drug: Naproxen
Naproxen 500mg PO BID x 7 days
Other Name: nonsteroidal anti-inflammatory 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: Methocarbamol
Methocarbamol 750mg 1-2 tabs po TID x 7 days
Other Name: Muscle relaxant

Drug: Naproxen
Naproxen 500mg PO BID x 7 days
Other Name: nonsteroidal anti-inflammatory drug


Outcome Measures
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Primary Outcome Measures :
  1. Functional Impairment as Measured on the Roland Morris Disability Questionnaire [ Time Frame: 1 week ]

    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.



Secondary Outcome Measures :
  1. Cases of Moderate or Severe LBP [ Time Frame: 1 week ]
    Participants with moderate to severe low back pain after treatment as report on the following ordinal scale: severe, moderate, mild, or none

  2. Medications--Patient Self Report of Medication Use [ Time Frame: 1 week ]
    Participants still using medication such as analgesics for LBP after treatment

  3. Patient Satisfaction With Treatment [ Time Frame: 1 week ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
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
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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


Locations
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United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
Investigators
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Principal Investigator: Benjamin W Friedman, MD, MS Albert Einstein College of Medicine
  Study Documents (Full-Text)

Documents provided by Benjamin W. Friedman, MD, Montefiore Medical Center:
Study Protocol and Statistical Analysis Plan  [PDF] January 27, 2016

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Benjamin W. Friedman, MD, Associate Professor, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT02665286    
Other Study ID Numbers: 2015-5903
First Posted: January 27, 2016    Key Record Dates
Results First Posted: June 26, 2018
Last Update Posted: June 26, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Orphenadrine
Methocarbamol
Cholinergic Antagonists
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Muscle Relaxants, Central
Neuromuscular Agents
Parasympatholytics
Autonomic Agents
Muscarinic Antagonists
Cytochrome P-450 CYP2B6 Inhibitors