Phase 4
N=320
Ibuprofen Plus Metaxolone, Tizanidine, or Baclofen for Low Back Pain
Low Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT03068897 ↗Enrolled (actual)
320
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire (RMDQ) — 10.1; 11.2; 10.6; 11.1 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Metaxalone (Drug); Tizanidine (Drug); Baclofen (Drug); Ibuprofen 600 mg (Drug); Educational intervention (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Montefiore Medical Center
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire (RMDQ) |
10.1; 11.2; 10.6; 11.1 | — |
| SECONDARY Number of Participants Who Experience Change in Low Back Pain |
28; 25; 26; 22 | — |
| SECONDARY Number of Participants With Need for Medication for Low Back Pain |
49; 48; 49; 46 | — |
| SECONDARY Levels of Disability |
5; 3; 6; 3 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT03068897). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.