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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

Tracking Information
First Submitted Date  ICMJE March 4, 2020
First Posted Date  ICMJE March 6, 2020
Last Update Posted Date August 27, 2021
Actual Study Start Date  ICMJE August 6, 2020
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 4, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2020)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2020)
Change in jaw functional limitations as measured by the jaw functional limitation scale [ Time Frame: Baseline, 3 weeks, 7 weeks, and 11 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Cannabinoids to Placebo in Management of TMJ Pain and Myofascial Pain in the TMJ Region
Official Title  ICMJE Comparison of Cannabinoids to Placebo in Management of Arthralgia and Myofascial Pain Disorder of the Temporomandibular Region: A Randomized Clinical Trial.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • TMJ Disorder
  • Myofacial Pain
  • TMD
Intervention  ICMJE
  • Other: CBD Oil
    CBD PURE CBD OIL 20mg/1ml concentration
    Other Name: Cannabinoids
  • Other: Hemp Oil
    CBD PURE HEMP OIL
Study Arms  ICMJE
  • Experimental: CBD Oil
    CBD PURE CBD OIL 20mg/1ml concentration - 1 ml (20mg) qd PO, hold under tongue for 1 minute and swallow daily
    Intervention: Other: CBD Oil
  • Placebo Comparator: Placebo (hemp oil)
    CBD PURE Hemp Oil- 1 ml qd PO, hold under tongue for 1 minute and swallow daily
    Intervention: Other: Hemp Oil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 4, 2020)
71
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gwendolyn Reeve, DMD FACS 212-746-5175 gsr9001@med.cornell.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04298554
Other Study ID Numbers  ICMJE 19-07020513
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Weill Medical College of Cornell University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Weill Medical College of Cornell University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Nutra Pure
Investigators  ICMJE
Principal Investigator: Gwendolyn Reeve, DMD FACS Weill Cornell New York Presbyterian Hospital
PRS Account Weill Medical College of Cornell University
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP