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

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ClinicalTrials.gov Identifier: NCT03068897
Recruitment Status : Completed
First Posted : March 3, 2017
Last Update Posted : November 8, 2018
Sponsor:
Information provided by (Responsible Party):
Benjamin W. Friedman, MD, Montefiore Medical Center

Tracking Information
First Submitted Date  ICMJE February 16, 2017
First Posted Date  ICMJE March 3, 2017
Last Update Posted Date November 8, 2018
Actual Study Start Date  ICMJE May 3, 2017
Actual Primary Completion Date July 11, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2017)
Roland Morris Disability Questionnaire (RMDQ) [ Time Frame: 7 days ]
Improvement in RMDQ between baseline and 7 days
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03068897 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2017)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ibuprofen Plus Metaxolone, Tizanidine, or Baclofen for Low Back Pain
Official Title  ICMJE Ibuprofen Plus Metaxolone, Tizanidine, or Baclofen for Low Back Pain: A Randomized Trial
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE Low Back Pain
Intervention  ICMJE
  • Drug: Metaxalone
    Metaxalone 400-800mg
  • Drug: Tizanidine
    Tizanidine 2-4mg
  • 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.
Study Arms  ICMJE
  • 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.

    Interventions:
    • Drug: Metaxalone
    • Drug: Ibuprofen 600 mg
    • Behavioral: Educational intervention
  • 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.

    Interventions:
    • Drug: Tizanidine
    • Drug: Ibuprofen 600 mg
    • Behavioral: Educational intervention
  • 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.

    Interventions:
    • Drug: Baclofen
    • Drug: Ibuprofen 600 mg
    • Behavioral: Educational intervention
  • 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.

    Interventions:
    • Drug: Ibuprofen 600 mg
    • Behavioral: Educational intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 1, 2017)
320
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 11, 2018
Actual Primary Completion Date July 11, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Gender Eligibility Description: per patient
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03068897
Other Study ID Numbers  ICMJE 2017-7566
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: IPD will not be available
Responsible Party Benjamin W. Friedman, MD, Montefiore Medical Center
Study Sponsor  ICMJE Montefiore Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Montefiore Medical Center
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP