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

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ClinicalTrials.gov Identifier: NCT03994640
Recruitment Status : Completed
First Posted : June 21, 2019
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
Aleksandra Nitecka-Buchta, Medical University of Silesia

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: two 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 : January 1, 2018
Actual Primary Completion Date : October 1, 2018
Actual Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Placeo cream topical skin application




Primary Outcome Measures :
  1. Reduction of sEMG activity of masseter muscle [ Time Frame: 14 days ]
    Reduction in masseter muscle electromyographic activity



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Ages Eligible for Study:   22 Years to 27 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03994640


Locations
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Poland
Department of TMD Silesian Medical University
Zabrze, Poland, 41-800
Sponsors and Collaborators
Medical University of Silesia

Publications:
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.

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Responsible Party: Aleksandra Nitecka-Buchta, Principal Investigator, Medical University of Silesia
ClinicalTrials.gov Identifier: NCT03994640     History of Changes
Other Study ID Numbers: Silesian UM Cannabis
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aleksandra Nitecka-Buchta, Medical University of Silesia:
temporomandibular disorder
Cannabis
Electromyography
Masticatory muscles
Topical application
Additional relevant MeSH terms:
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Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Musculoskeletal Diseases
Joint Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes