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

NCT03068897 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 2017-7566
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire (RMDQ)

  The Roland Morris Disability Questionnaire (RMDQ) is a 24 item instrument that evaluates the impact of low back pain on one's daily life. It is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. Each question can be answered as either a "yes" or "no". The score ranges from 0 to 24 where a higher score reflects greater impairment and, therefore, worsening in the quality of life. The change in RMDQ is obtained by subtracting the RMDQ score at one week after discharge from the baseline score.

  Baseline and 7 days

Secondary Outcomes (3)

• Number of Participants Who Experience Change in Low Back Pain

  Baseline and 7 days

• Number of Participants With Need for Medication for Low Back Pain

  7 days

• Levels of Disability

  7 days

Study Arms (4)

Metaxalone

ACTIVE COMPARATOR

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; Drug: Ibuprofen 600 mg; Behavioral: Educational intervention

Tizanidine

ACTIVE COMPARATOR

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; Drug: Ibuprofen 600 mg; Behavioral: Educational intervention

Baclofen

ACTIVE COMPARATOR

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; Drug: Ibuprofen 600 mg; Behavioral: Educational intervention

Placebo

PLACEBO COMPARATOR

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; Behavioral: Educational intervention

Interventions

Metaxalone DRUG

Metaxalone 400-800mg

Metaxalone

Tizanidine DRUG

Tizanidine 2-4mg

Tizanidine

Baclofen DRUG

Baclofen 10-20mg

Baclofen

Ibuprofen 600 mg DRUG

Ibuprofen

Baclofen; Metaxalone; Placebo; Tizanidine

Educational intervention BEHAVIORAL

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.

Baclofen; Metaxalone; Placebo; Tizanidine

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: per patient
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Publications (1)

• 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.

  PMID: 30955985 DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

metaxalone; tizanidine; Baclofen; Ibuprofen; Early Intervention, Educational

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenylpropionates; Acids, Carbocyclic; Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Results Point of Contact

• Title: Dr. Benjamin W. Friedman
• Organization: Montefiore

befriedm@montefiore.org

718-920-6626

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Medications provided to patients are encapsulated. Medications vials are labelled with investigational stickers.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2017
• First Posted: March 3, 2017
• Study Start: May 3, 2017
• Primary Completion: July 11, 2018
• Study Completion: October 11, 2018
• Last Updated: August 12, 2020
• Results First Posted: August 12, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)