We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ibuprofen Plus Metaxolone, Tizanidine, or Baclofen for Low Back Pain

This study is currently recruiting participants.
Verified May 2017 by Benjamin Friedman, Montefiore Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT03068897
First Posted: March 3, 2017
Last Update Posted: May 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Benjamin Friedman, Montefiore Medical Center
  Purpose
This is a randomized study, based in emergency departments, in which the investigators determine the utility of adding various skeletal muscle relaxants to standard therapy, which consists of ibuprofen and an educational session. Patients will be enrolled at the time of an emergency visit and followed for three months to determine outcomes.

Condition Intervention Phase
Low Back Pain Drug: Metaxalone Drug: Tizanidine Drug: Baclofen Drug: Ibuprofen 600 mg Behavioral: Educational intervention Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Medications provided to patients are encapsulated. Medications vials are labelled with investigational stickers.
Primary Purpose: Treatment
Official Title: Ibuprofen Plus Metaxolone, Tizanidine, or Baclofen for Low Back Pain: A Randomized Trial

Resource links provided by NLM:


Further study details as provided by Benjamin Friedman, Montefiore Medical Center:

Primary Outcome Measures:
  • Roland Morris Disability Questionnaire (RMDQ) [ Time Frame: 7 days ]
    Improvement in RMDQ between baseline and 7 days


Secondary Outcome Measures:
  • Pain scale [ Time Frame: 48 hours, 7 days, 3 months ]
    Severe, moderate, mild, or no low back pain

  • Need for medication for low back pain [ Time Frame: 48 hours, 7 days, 3 months ]
    Patients will be asked what medications they have used for low back pain

  • Absolute score on Roland Morris Disability Questionnaire [ Time Frame: 7 days, 3 months ]
    This is a commonly used scale in low back pain research. It measures the impact of low back pain on one's life.


Estimated Enrollment: 320
Actual Study Start Date: May 3, 2017
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Metaxalone

Ibuprofen 600mg mg + metaxalone 400-800mg every 8 hours, as needed for low back pain, x 7 days.

All participants receive a brief educational intervention.

Drug: Metaxalone
Metaxalone 400-800mg
Drug: Ibuprofen 600 mg
Ibuprofen
Behavioral: Educational intervention
Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions.
Active Comparator: Tizanidine

Ibuprofen 600mg mg + tizanidine 2-4mg every 8 hours, as needed for low back pain, x 7 days.

All participants receive a brief educational intervention.

Drug: Tizanidine
Tizanidine 2-4mg
Drug: Ibuprofen 600 mg
Ibuprofen
Behavioral: Educational intervention
Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions.
Active Comparator: Baclofen

Ibuprofen 600mg mg + baclofen 10-20 mg every 8 hours, as needed for low back pain, x 7 days.

All participants receive a brief educational intervention.

Drug: Baclofen
Baclofen 10-20mg
Drug: Ibuprofen 600 mg
Ibuprofen
Behavioral: Educational intervention
Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions.
Placebo Comparator: Placebo

Ibuprofen 600mg mg + placebo, 1 or 2 capsules, every 8 hours, as needed for low back pain, x 7 days.

All participants receive a brief educational intervention.

Drug: Ibuprofen 600 mg
Ibuprofen
Behavioral: Educational intervention
Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   per patient
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Present to ED primary for management of LBP, defined as pain originating between the lower border of the scapulae and the upper gluteal folds. Flank pain, that is pain originating from tissues lateral to the paraspinal muscles, will not be included.
  • Musculoskeletal etiology of low back. Patients with non-musculoskeletal etiologies such as urinary tract infection, ovarian cysts, or influenza like illness will be excluded. The primary clinical diagnosis, at the conclusion of the ED visit, must be a diagnosis consistent with non-traumatic, non-radicular, musculoskeletal LBP.
  • Patient is to be discharged home. Patients admitted to the hospital are more likely to be treated with parenteral medication and therefore are not appropriate for this study.
  • Age 18-64 Enrollment will be limited to adults younger than 65 years because of the increased risk of adverse medication effects in the elderly.
  • Non-radicular pain. Patients will be excluded if the pain radiates below the gluteal folds in a radicular pattern.
  • Pain duration <2 weeks (336 hours). Patients with more than two weeks of pain are at increased risk of poor pain and functional outcomes.(9)
  • Prior to the acute attack of LBP, back pain cannot occur more frequently than once per month. Patients with more frequent back pain are at increased risk of poor pain and functional outcomes.(9)
  • Non-traumatic LBP: no substantial and direct trauma to the back within the previous month
  • Functionally impairing back pain: A baseline score of > 5 on the Roland-Morris Disability Questionnaire

Exclusion Criteria:

  • Not available for follow-up
  • Pregnant or breast-feeding
  • Chronic pain syndrome defined as use of any analgesic medication on a daily or near-daily basis
  • Allergic to or intolerant of investigational medications
  • Contra-indications to non-steroidal anti-inflammatory drugs: 1) history of hypersensitivity to NSAIDs or aspirin 2) active or history of peptic ulcer disease, chronic dyspepsia, or active or history of gastrointestinal bleed 3) Severe heart failure (NYHA 2 or worse) 4) hypertension (JNC7 stage 2 or worse) 5) Chronic kidney disease 3 or worse 6) Current use of anti-coagulants 7) Hepatitis 8) Alcoholism
  • Contra-indications to muscle relaxants: 1) Concurrent use of centrally acting opioids; 2) Renal impairment; 3) Liver abnormality including cirrhosis or elevated enzymes 4) Use of any of the following medications: fluvoxamine, fluoroquinolones, amiodarone, mexiletine, propafenone, verapamil, cimetidine, famotidine, acyclovir, ticlopidine, oral contraceptive pills
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03068897


Contacts
Contact: Benjamin W Friedman 718-920-6626 befriedm@montefiore.org

Locations
United States, New York
Montefiore Medical Center Recruiting
The Bronx, New York, United States, 10467
Contact: Benjamin W. Friedman, MD, MS       befriedm@montefiore.org   
Sponsors and Collaborators
Montefiore Medical Center
  More Information

Responsible Party: Benjamin Friedman, Associate professor of emergency medicine, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT03068897     History of Changes
Other Study ID Numbers: 2017-7566
First Submitted: February 16, 2017
First Posted: March 3, 2017
Last Update Posted: May 5, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be available

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Ibuprofen
Tizanidine
Clonidine
Oxazolidinones
Metaxalone
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticonvulsants
Muscle Relaxants, Central
Neuromuscular Agents
Parasympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists