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
Brief Title
Orphenadrine and Methocarbamol for LBP
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
Categories
Completion Date
Completion Date Type
Actual
Conditions
Low Back Pain
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
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
69 Years
Minimum Age
18 Years
NCT Id
NCT02665286
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2015-5903
Overall Status
Completed
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Methocarbamol and Orphenadrine for Acute, Non-traumatic, Non-radicular Low Back Pain: A Randomized, Placebo Controlled, 3-armed Study
Primary Outcomes
Outcome 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.
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.
Outcome Measure
Functional Impairment as Measured on the Roland Morris Disability Questionnaire
Outcome Time Frame
1 week
Secondary Outcomes
Outcome Description
Participants with moderate to severe low back pain after treatment as report on the following ordinal scale: severe, moderate, mild, or none
Outcome Time Frame
1 week
Outcome Measure
Cases of Moderate or Severe LBP
Outcome Description
Participants still using medication such as analgesics for LBP after treatment
Outcome Time Frame
1 week
Outcome Measure
Medications--Patient Self Report of Medication Use
Outcome 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.
Outcome Time Frame
1 week
Outcome Measure
Patient Satisfaction With Treatment
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
69
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Benjamin Friedman
Investigator Email
befriedm@montefiore.org
Investigator Phone
646-265-6415