Clinical trial NCT03994640: Myorelaxant Effect of Cannabis Cream Topical Skin Application in Patients With TMD
Official title: Myorelaxant Effect of Cannabis Cream Topical Skin Application in Patients With Temporomandibular Disorders: a Randomized, Double-blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Temporomandibular Disorder
Myofascial Pain
Cannabis
Electromyography
Keywords: temporomandibular disorder
Cannabis
Electromyography
Masticatory muscles
Topical application
Lead sponsor: Medical University of Silesia
Sponsor class: OTHER
First posted: 2019-06-21
Enrollment: 20
Sex: ALL
Minimum age (years): 22
Maximum age (years): 27
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two groups parallel study: experimental and control group
Primary purpose: TREATMENT

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

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.

Eligibility 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

Primary outcomes:
measure: Reduction of sEMG activity of masseter muscle
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Zabrze
country: Poland
facility: Department of TMD Silesian Medical University
Study officials:
References:
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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 Groupdagger. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151.