CompletedNot Applicable

Comparison of Cannabinoids to Placebo in Management of TMJ Pain and Myofascial Pain in the TMJ Region

United States59 participantsStarted 2020-08-06

Plain-language summary

The aim of this study is to determine whether the cannabinoids taken orally in the form of cannabidiol (CBD oil-a major non-psychoactive component of marijuana) vs placebo (hemp oil) will provide pain relief and improved jaw function in those who suffer from either myofascial pain disorder and/or arthralgia of the temporomandibular region. 1. Primary Objectives To determine if the consumption of CBD oil is superior to placebo for the improvement in jaw pain. 2. Secondary Objectives To determine if the consumption of CBD oil is superior to placebo for the improvement in function of the temporomandibular joint. 3. Exploratory Objectives To determine if there are any adverse effects that result from the consumption of CBD oil or placebo.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Men and women 18-70 years of age * Ability to give informed consent * Arthralgia of the temporomandibular joint as defined according to the RDC/TMD criteria (see below chart)\[3\] and/or Myofascial pain of masticatory muscles as defined according to the RDC/TMD criteria (see below chart)\[3\] * Baseline pain must be greater than 3/10 as self-reported on the VAS Exclusion Criteria: * Allergy to study drug * Traumatic injury of masticatory muscles or temporomandibular joint within last 12 months * Mandibular fracture within last 12 months * Pregnancy or breast feeding * Initiation of additional treatment of MPD within the past 1 months * Baseline pain less than 3/10 as self-reported on the VAS

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in baseline in pain, as measured by the Visual Analog Scale (VAS)

Timeframe: Baseline, 3 weeks, 7 weeks, and 11 weeks

Trial details

NCT IDNCT04298554

SponsorWeill Medical College of Cornell University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05-29

View on ClinicalTrials.gov More TMJ Disorder trials