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

Temporomandibular Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03994640
• Other study ID #: Silesian UM Cannabis
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: January 1, 2018
• Est. completion date: January 1, 2019

Study information

• Verified date: June 2019
• Source: Medical University of Silesia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 1, 2019
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 27 Years

Eligibility

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

Related Conditions & MeSH terms

• Cannabis
• Electromyography
• Marijuana Abuse
• Myofascial Pain
• Temporomandibular Disorder
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Combination Product:
• Cannabis Cream
Topical, bilateral skin application of cannabis cream with self-massage of masseter muscles
• Placebo Cream
Topical, bilteral skin application of placebo cream with self-massage of masseter muscles

Locations

Country	Name	City	State
Poland	Department of TMD Silesian Medical University	Zabrze

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Silesia

Country where clinical trial is conducted

Poland, 

References & Publications (3)

Koppel BS, Brust JC, Fife T, Bronstein J, Youssof S, Gronseth G, Gloss D. Systematic review: efficacy and safety of medical marijuana in selected neurologic disorders: report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology. 2014 Apr 29;82(17):1556-63. doi: 10.1212/WNL.0000000000000363. Review. — View Citation

Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, List T, Svensson P, Gonzalez Y, Lobbezoo F, Michelotti A, Brooks SL, Ceusters W, Drangsholt M, Ettlin D, Gaul C, Goldberg LJ, Haythornthwaite JA, Hollender L, Jensen R, John MT, De Laat A, de Leeuw R, Maixner W, van der Meulen M, Murray GM, Nixdorf DR, Palla S, Petersson A, Pionchon P, Smith B, Visscher CM, Zakrzewska J, Dworkin SF; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Group†. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151. — View Citation

Vaney C, Heinzel-Gutenbrunner M, Jobin P, Tschopp F, Gattlen B, Hagen U, Schnelle M, Reif M. Efficacy, safety and tolerability of an orally administered cannabis extract in the treatment of spasticity in patients with multiple sclerosis: a randomized, double-blind, placebo-controlled, crossover study. Mult Scler. 2004 Aug;10(4):417-24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of sEMG activity of masseter muscle	Reduction in masseter muscle electromyographic activity	14 days