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

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

Detailed Description
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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.

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

Conditions
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Temporomandibular Disorder, Myofascial Pain, Cannabis, Electromyography

Intervention / Treatment
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* Combination Product: Cannabis Cream
* Combination Product: Placebo Cream


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 27 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: two groups parallel study: experimental and control group
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cannabis cream<br>Cannabis cream topical skin application in experimental group | Combination Product: Cannabis Cream<br>* Topical, bilateral skin application of cannabis cream with self-massage of masseter muscles<br>* Other names: Cannabis cream topical skin application;|
| Placebo Comparator: Placebo cream<br>Placebo cream topical skin application in control group | Combination Product: Placebo Cream<br>* Topical, bilteral skin application of placebo cream with self-massage of masseter muscles<br>* Other names: Placeo cream topical skin application;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of sEMG activity of masseter muscle | Reduction in masseter muscle electromyographic activity | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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temporomandibular disorder, Cannabis, Electromyography, Masticatory muscles, Topical application