Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 69 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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 names:
    • 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 names:
    • anticholinergic drug
  • Drug: Naproxen
    Naproxen 500mg PO BID x 7 days
    Other names:
    • 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 names:
    • Muscle relaxant
  • Drug: Naproxen
    Naproxen 500mg PO BID x 7 days
    Other names:
    • nonsteroidal anti-inflammatory drug

More Details

Status
Completed
Sponsor
Montefiore Medical Center

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.