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Orphenadrine and Methocarbamol for LBP

Primary Purpose

Low Back Pain

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Orphenadrine
Methocarbamol
Naproxen
Placebo
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Montefiore Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Placebo

Orphenadrine

Methocarbamol

Arm Description

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

Naproxen 500mg, orally twice per day + orphenadrine 100mg, orally twice per day for 10 days Naproxen 500mg po BID x 10 days #20 + Orphenadrine

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Medications--Patient Self Report of Medication Use
Participants still using medication such as analgesics for LBP after treatment
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.

Full Information

First Posted
January 15, 2016
Last Updated
May 29, 2018
Sponsor
Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02665286
Brief Title
Orphenadrine and Methocarbamol for LBP
Official Title
Methocarbamol and Orphenadrine for Acute, Non-traumatic, Non-radicular Low Back Pain: A Randomized, Placebo Controlled, 3-armed Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montefiore Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
Orphenadrine
Arm Type
Active Comparator
Arm Description
Naproxen 500mg, orally twice per day + orphenadrine 100mg, orally twice per day for 10 days Naproxen 500mg po BID x 10 days #20 + Orphenadrine
Arm Title
Methocarbamol
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Orphenadrine
Other Intervention Name(s)
anticholinergic drug
Intervention Description
Orphenadrine 100mg PO BID x 7 days
Intervention Type
Drug
Intervention Name(s)
Methocarbamol
Other Intervention Name(s)
Muscle relaxant
Intervention Description
Methocarbamol 750mg 1-2 tabs po TID x 7 days
Intervention Type
Drug
Intervention Name(s)
Naproxen
Other Intervention Name(s)
nonsteroidal anti-inflammatory drug
Intervention Description
Naproxen 500mg PO BID x 7 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Functional Impairment as Measured on the Roland Morris Disability Questionnaire
Description
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 Outcome Measure Information:
Title
Cases of Moderate or Severe LBP
Description
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
Title
Medications--Patient Self Report of Medication Use
Description
Participants still using medication such as analgesics for LBP after treatment
Time Frame
1 week
Title
Patient Satisfaction With Treatment
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin W Friedman, MD, MS
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29089169
Citation
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.
Results Reference
derived

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Orphenadrine and Methocarbamol for LBP

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