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OpenTrials
Completed

NCT Number: NCT02665286

Orphenadrine and Methocarbamol for LBP

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

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Montefiore Medical Center

The Bronx, New York, 10467, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

orphenadrine

Drug

Orphenadrine 100mg PO BID x 7 days

Other names: anticholinergic drug

Methocarbamol

Drug

Methocarbamol 750mg 1-2 tabs po TID x 7 days

Other names: Muscle relaxant

Naproxen

Drug

Naproxen 500mg PO BID x 7 days

Other names: nonsteroidal anti-inflammatory drug

Placebo

Drug

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 27, 2016
Registry last updated
Jun 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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