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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 27, 2021
Sponsor:
Collaborator:
Nutra Pure
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Study Description
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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
TMJ Disorder Myofacial Pain TMD Other: CBD Oil Other: Hemp Oil Not Applicable

Study Design
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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
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : December 2022
Arms and Interventions
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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 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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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
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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Gwendolyn Reeve, DMD FACS 212-746-5175 gsr9001@med.cornell.edu

Locations
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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         
Sponsors and Collaborators
Weill Medical College of Cornell University
Nutra Pure
Investigators
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Principal Investigator: Gwendolyn Reeve, DMD FACS Weill Cornell New York Presbyterian Hospital
More Information
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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 27, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Temporomandibular Joint Disorders
Facial Pain
Pain
Neurologic Manifestations
Craniomandibular Disorders
Mandibular Diseases
 Jaw Diseases
Musculoskeletal Diseases
Joint Diseases
Muscular Diseases
Stomatognathic Diseases