Einstein Montefiore

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

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

Low Back Pain

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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

Study Design

Phase: Phase 4
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Medications provided to patients are encapsulated. Medications vials are labelled with investigational stickers.

Arm Groups

Arm	Description	Assigned Intervention
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.

More Details

Status: Completed
Sponsor: Montefiore Medical Center

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.