Testing a new medication for low back and leg pain relief.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of a modified metaxalone 640 mg in alleviating pain associated with acute lumbosacral musculoskeletal conditions, specifically sciatica and lumbar spinal stenosis. Participants aged 18 to 80 with newly occurring back or leg pain will be randomly assigned to receive either the active treatment or a placebo in a double-blind manner. The study will assess pain levels, physical activity interference, and sleep disruption through surveys conducted before treatment and one week after. The trial is designed to gather robust data on the medication's efficacy compared to a look-alike substance without active ingredients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* No clinically significant conditions impacting quality or quantity of pain
* Baseline Numeric Pain Scale ≥ 6
* Capable of answering text or email survey reminders
* Low back pain with or without sciatica

Exclusion Criteria:

* Current use of other skeletal relaxants
* Current use of other pain relievers
* Current use of cimetidine or monoamine oxidase inhibitors

Where it's running

• Robert Levin, MD
  Clearwater, Florida, United States Recruiting
• 5. CZ Rheumatology
  Coral Springs, Florida, United States Recruiting
• Arthritis and Osteoporosis Treatment and ResearchCenter
  Miami, Florida, United States Recruiting
• CZ Rheumatology
  Miami Beach, Florida, United States Recruiting
• Bay Area Rheumatology
  Oldsmar, Florida, United States Recruiting
• Arthritis and Rheumatology Center of MI
  Sterling Heights, Michigan, United States Recruiting

Study contacts

• Study coordinator: S Sodhi
• Email: simi@illumination.health
• Phone: 205-202-0739

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.