Comparison of Cannabinoids to Placebo in Management of TMJ Pain and Myofascial Pain in the TMJ Region
Keywords
Abstract
Dates
| Last Verified: | 02/29/2020 |
| First Submitted: | 03/03/2020 |
| Estimated Enrollment Submitted: | 03/03/2020 |
| First Posted: | 03/05/2020 |
| Last Update Submitted: | 03/03/2020 |
| Last Update Posted: | 03/05/2020 |
| Actual Study Start Date: | 06/30/2020 |
| Estimated Primary Completion Date: | 12/31/2021 |
| Estimated Study Completion Date: | 02/28/2022 |
Condition or disease
Intervention/treatment
Other: CBD Oil
Other: Placebo (hemp oil)
Phase
Arm Groups
| 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 | Other: CBD Oil CBD PURE CBD OIL 20mg/1ml concentration |
| Placebo Comparator: Placebo (hemp oil) CBD PURE Hemp Oil- 1 ml qd PO, hold under tongue for 1 minute and swallow daily | Other: Placebo (hemp oil) CBD PURE HEMP OIL |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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 |
Outcome
Primary Outcome Measures
1. Change in baseline in pain, as measured by the Visual Analog Scale (VAS) [Baseline, 3 weeks, 7 weeks, and 11 weeks]
Secondary Outcome Measures
1. Change in jaw functional limitations as measured by the jaw functional limitation scale [Baseline, 3 weeks, 7 weeks, and 11 weeks]
