Myorelaxant Effect of Cannabis Cream Topical Skin Application in Patients With TMD

June 20, 2019 updated by: Aleksandra Nitecka-Buchta, Medical University of Silesia

Myorelaxant Effect of Cannabis Cream Topical Skin Application in Patients With Temporomandibular Disorders: a Randomized, Double-blind Study

Evaluation of myorelaxant effect of cannabis cream.compared to placebo cream in topical skin application in patients with TMD

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cannabis sativa has a very wide application in various fields of medicine. In patients with temporomandibular disorder, especially with myofascial pain of masticatory muscles there is a special need to seek an effective pain therapy and muscle relaxing methods. Patients with TMD suffer from chronic pain and depression, cannabis topical skin application therapy seems promising in that field. Patients attending The Department of TMD in Zabrze, Polska were randomly divided into two groups: experimental and placebo. sEMG activity values were compared during 14 days therapy with cream. Positive results were obtained confirming the efficacy of the cannabis cream used in the study, compared to placebo.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Zabrze, Poland, 41-800
        • Department of TMD Silesian Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 23 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

The inclusion criteria were as follows:

  1. Patient agreement to participate into the research study
  2. Age ≥22 and ≤ 27
  3. Good general health,
  4. Temporomandibular disorder-positive RDC/TMD examination for group Ia and Ib
  5. Presence of all teeth (with the exception of the third molars)

The exclusion criteria were:

  1. Cannabis cream/ placebo cream allergy
  2. Hypersensitivity to substances to be used in the study
  3. Skin wounds with skin surface discontinuation
  4. Addiction to cannabis
  5. Patients being treated with analgesic drugs and/or drugs that affect muscle function
  6. Fixed or removable dental prosthesis
  7. Disease or autoimmune disorder associated with generalized muscular tension

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cannabis cream
Cannabis cream topical skin application in experimental group
Combination product: Cannabis Cream
Topical, bilateral skin application of cannabis cream with self-massage of masseter muscles
Other Names:
  • Cannabis cream topical skin application
Placebo Comparator: Placebo cream
Placebo cream topical skin application in control group
Combination product: Placebo Cream
Topical, bilteral skin application of placebo cream with self-massage of masseter muscles
Other Names:
  • Placeo cream topical skin application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of sEMG activity of masseter muscle
Time Frame: 14 days
Reduction in masseter muscle electromyographic activity
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Silesia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

June 17, 2019

First Submitted That Met QC Criteria

June 20, 2019

First Posted (Actual)

June 21, 2019

Study Record Updates

Last Update Posted (Actual)

June 21, 2019

Last Update Submitted That Met QC Criteria

June 20, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Silesian UM Cannabis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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