Skip to main content
OpenTrials
Completed

NCT Number: NCT03994640

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Temporomandibular Disorder Cannabis Chemically-Induced Disorders Craniomandibular Disorders Electromyography Jaw Diseases Joint Diseases Mandibular Diseases Marijuana Abuse Mental Disorders Muscular Diseases Musculoskeletal Diseases Myofascial Pain Stomatognathic Diseases Substance-Related Disorders Temporomandibular Joint Disorders

Age range

22 year–27 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department of TMD Silesian Medical University

Zabrze, 41-800, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

The inclusion criteria were as follows:

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

The exclusion criteria were:

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

Treatment and study plan

Cannabis Cream

Combination Product

Topical, bilateral skin application of cannabis cream with self-massage of masseter muscles

Other names: Cannabis cream topical skin application

Placebo Cream

Combination Product

Topical, bilteral skin application of placebo cream with self-massage of masseter muscles

Other names: Placeo cream topical skin application

Primary outcomes

  1. Reduction of sEMG activity of masseter muscle

    Time frame: 14 days

    Reduction in masseter muscle electromyographic activity

Sponsors and collaborators

Lead sponsor

Medical University of Silesia

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jun 21, 2019
Registry last updated
Jun 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.