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

• Sponsor: Medical University of Silesia (Other)
• Overall Status: Completed
• CT.gov ID: NCT03994640
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Actual Duration (Months): 12
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Temporomandibular Disorder; Myofascial Pain; Cannabis; Electromyography	Combination Product: Cannabis Cream; Combination Product: Placebo Cream	Phase 2/Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: two groups parallel study: experimental and control grouptwo groups parallel study: experimental and control group
• Masking: Double (Participant, Care Provider)
• Masking Description: double blind study: for patients and researchers
• Primary Purpose: Treatment
• Official Title: Myorelaxant Effect of Cannabis Cream Topical Skin Application in Patients With Temporomandibular Disorders: a Randomized, Double-blind Study
• Actual Study Start Date: Jan 1, 2018
• Actual Primary Completion Date: Oct 1, 2018
• Actual Study Completion Date: Jan 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Reduction of sEMG activity of masseter muscle [14 days]

   Reduction in masseter muscle electromyographic activity

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years to 27 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of TMD Silesian Medical University	Zabrze		Poland	41-800

Sponsors and Collaborators

• Medical University of Silesia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: Aleksandra Nitecka-Buchta, Principal Investigator, Medical University of Silesia
• ClinicalTrials.gov Identifier: NCT03994640
• Other Study ID Numbers: Silesian UM Cannabis
• First Posted: Jun 21, 2019
• Last Update Posted: Jun 21, 2019
• Last Verified: Jun 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Aleksandra Nitecka-Buchta, Principal Investigator, Medical University of Silesia: temporomandibular disorder; Cannabis; Electromyography; Masticatory muscles; Topical application
• Additional relevant MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Marijuana Abuse

Study Results

No Results Posted as of Jun 21, 2019