Comparison of Cannabinoids to Placebo in Management of TMJ Pain and Myofascial Pain in the TMJ Region
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ClinicalTrials.gov Identifier: NCT04298554 |
Recruitment Status :
Recruiting
First Posted : March 6, 2020
Last Update Posted : August 23, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
TMJ Disorder Myofacial Pain TMD | Other: CBD Oil Other: Hemp Oil | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 71 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Comparison of Cannabinoids to Placebo in Management of Arthralgia and Myofascial Pain Disorder of the Temporomandibular Region: A Randomized Clinical Trial. |
Actual Study Start Date : | August 6, 2020 |
Actual Primary Completion Date : | July 30, 2022 |
Estimated Study Completion Date : | December 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: CBD Oil
CBD PURE CBD OIL 20mg/1ml concentration - 1 ml (20mg) qd PO, hold under tongue for 1 minute and swallow daily
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Other: CBD Oil
CBD PURE CBD OIL 20mg/1ml concentration
Other Name: Cannabinoids |
Placebo Comparator: Placebo (hemp oil)
CBD PURE Hemp Oil- 1 ml qd PO, hold under tongue for 1 minute and swallow daily
|
Other: Hemp Oil
CBD PURE HEMP OIL |
- Change in baseline in pain, as measured by the Visual Analog Scale (VAS) [ Time Frame: Baseline, 3 weeks, 7 weeks, and 11 weeks ]Scores are measured from 1-100mm VAS. The VAS ranges from 0 to 100 with O indicating no pain and higher scores indicating a greater pain.
- Change in jaw functional limitations as measured by the jaw functional limitation scale. [ Time Frame: Baseline, 3 weeks, 7 weeks, and 11 weeks ]Scores are measured from 5 (lowest) to 25 (highest). Higher scores reflect better jaw function.

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04298554
Contact: Gwendolyn Reeve, DMD FACS | 212-746-5175 | gsr9001@med.cornell.edu |
United States, New York | |
Weill Cornell Medicine | Recruiting |
New York, New York, United States, 10028 | |
Contact: Gwendolyn Reeve, DMD FACS 212-746-5175 gsr9001@med.cornell.edu | |
Principal Investigator: Gwendolyn Reeve, DMD FACS |
Principal Investigator: | Gwendolyn Reeve, DMD FACS | Weill Cornell New York Presbyterian Hospital |
Responsible Party: | Weill Medical College of Cornell University |
ClinicalTrials.gov Identifier: | NCT04298554 |
Other Study ID Numbers: |
19-07020513 |
First Posted: | March 6, 2020 Key Record Dates |
Last Update Posted: | August 23, 2022 |
Last Verified: | August 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
CBD TMJ TMD |
Temporomandibular Joint Disorders Facial Pain Pain Neurologic Manifestations Craniomandibular Disorders Mandibular Diseases |
Jaw Diseases Musculoskeletal Diseases Joint Diseases Muscular Diseases Stomatognathic Diseases |