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History of Changes for Study: NCT04298554
Comparison of Cannabinoids to Placebo in Management of TMJ Pain and Myofascial Pain in the TMJ Region
Latest version (submitted August 22, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 4, 2020 None (earliest Version on record)
2 August 6, 2020 Recruitment Status, Study Status, Outcome Measures, Contacts/Locations and Oversight
3 August 26, 2021 Study Status
4 August 22, 2022 Study Status
Comparison Format:

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Study NCT04298554
Submitted Date:  March 4, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: 19-07020513
Brief Title: Comparison of Cannabinoids to Placebo in Management of TMJ Pain and Myofascial Pain in the TMJ Region
Official Title: Comparison of Cannabinoids to Placebo in Management of Arthralgia and Myofascial Pain Disorder of the Temporomandibular Region: A Randomized Clinical Trial.
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2020
Overall Status: Not yet recruiting
Study Start: July 2020
Primary Completion: January 2022 [Anticipated]
Study Completion: March 2022 [Anticipated]
First Submitted: March 4, 2020
First Submitted that
Met QC Criteria:
March 4, 2020
First Posted: March 6, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
March 4, 2020
Last Update Posted: March 6, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Weill Medical College of Cornell University
Responsible Party: Sponsor
Collaborators: Nutra Pure
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module 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.
Detailed Description:
Open or close this module Conditions
Conditions: TMJ Disorder
Myofacial Pain
TMD
Keywords: CBD
TMJ
TMD
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Single (Participant)
Allocation: Randomized
Enrollment: 71 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: CBD Oil
CBD PURE CBD OIL 20mg/1ml concentration - 1 ml (20mg) qd PO, hold under tongue for 1 minute and swallow daily
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
Hemp Oil
CBD PURE HEMP OIL
Open or close this module Outcome Measures
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 ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 70 Years
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Gwendolyn Reeve, DMD FACS
Telephone: 212-746-5175
Email: gsr9001@med.cornell.edu
Study Officials: Gwendolyn Reeve, DMD FACS
Principal Investigator
Weill Cornell New York Presbyterian Hospital
Locations: United States, New York
Weill Cornell Medicine
New York, New York, United States, 10028
Contact:Contact: Gwendolyn Reeve, DMD FACS 212-746-5175 gsr9001@med.cornell.edu
Contact:Principal Investigator: Gwendolyn Reeve, DMD FACS
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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