Clinical trial NCT03068897: Ibuprofen Plus Metaxolone, Tizanidine, or Baclofen for Low Back Pain
Official title: Ibuprofen Plus Metaxolone, Tizanidine, or Baclofen for Low Back Pain: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Low Back Pain
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2017-03-03
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire (RMDQ)
timeFrame: Baseline and 7 days
Secondary outcomes:
measure: Number of Participants Who Experience Change in Low Back Pain
timeFrame: Baseline and 7 days
measure: Number of Participants With Need for Medication for Low Back Pain
timeFrame: 7 days
measure: Levels of Disability
timeFrame: 7 days
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
References:
citation: Friedman BW, Irizarry E, Solorzano C, Zias E, Pearlman S, Wollowitz A, Jones MP, Shah PD, Gallagher EJ. A Randomized, Placebo-Controlled Trial of Ibuprofen Plus Metaxalone, Tizanidine, or Baclofen for Acute Low Back Pain. Ann Emerg Med. 2019 Oct;74(4):512-520. doi: 10.1016/j.annemergmed.2019.02.017. Epub 2019 Apr 5.