Ibuprofen Plus Metaxolone, Tizanidine, or Baclofen for Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Intervention: Metaxalone; Tizanidine; Baclofen; Ibuprofen 600 mg; Educational intervention
Intervention description: Metaxalone 400-800mg; Tizanidine 2-4mg; Baclofen 10-20mg; Ibuprofen; 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.
Intervention MeSH terms: Ibuprofen; Tizanidine; Baclofen; Metaxalone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
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.
Enrollment: 320.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility 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