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

Sponsor
Weill Medical College of Cornell University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04298554
Collaborator
Nutra Pure (Other)
71
Enrollment
1
Location
2
Arms
27.8
Anticipated Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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) or 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. The study hypothesis is that CBD oil is superior to placebo.

Condition or Disease Intervention/Treatment Phase
  • Other: CBD Oil
  • Other: Hemp Oil
 N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Aug 6, 2020
Actual Primary Completion Date :
Jul 30, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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
Other Names:
  • 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

    Outcome Measures

    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]

      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.

    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]

      Scores are measured from 5 (lowest) to 25 (highest). Higher scores reflect better jaw function.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Weill Cornell Medicine New York New York United States 10028

    Sponsors and Collaborators

    • Weill Medical College of Cornell University
    • Nutra Pure

    Investigators

    • Principal Investigator: Gwendolyn Reeve, DMD FACS, Weill Cornell New York Presbyterian Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Weill Medical College of Cornell University
    ClinicalTrials.gov Identifier:
    NCT04298554
    Other Study ID Numbers:
    • 19-07020513
    First Posted:
    Mar 6, 2020
    Last Update Posted:
    Aug 23, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Weill Medical College of Cornell University
    CBD
    TMJ
    TMD
    Additional relevant MeSH terms:
    Temporomandibular Joint Disorders
    Facial Pain

    Study Results

    No Results Posted as of Aug 23, 2022