Orphenadrine and Methocarbamol for LBP

Low Back Pain Clinical Trial

Official title:

Methocarbamol and Orphenadrine for Acute, Non-traumatic, Non-radicular Low Back Pain: A Randomized, Placebo Controlled, 3-armed Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02665286
• Other study ID #: 2015-5903
• Status: Completed
• Phase: Phase 4
• Start date: March 2016
• Est. completion date: May 2017

Study information

• Verified date: May 2018
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: May 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Drug:
• Orphenadrine
Orphenadrine 100mg PO BID x 7 days
• Methocarbamol
Methocarbamol 750mg 1-2 tabs po TID x 7 days
• Naproxen
Naproxen 500mg PO BID x 7 days
• 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

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	1 week
Secondary	Medications--Patient Self Report of Medication Use	Participants still using medication such as analgesics for LBP after treatment	1 week
Secondary	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.	1 week