Myorelaxant Effect of Cannabis Cream Topical Skin Application in Patients With Temporomandibular Disorders: a Randomized, Double-blind Study
| Registry | NCT03994640 |
|---|---|
| Status | Completed |
| Phase | Phase 2 / Phase 3 |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 20 (Actual) |
| Sponsor | Medical University of Silesia (Other) |
| Conditions | Temporomandibular Disorder, Myofascial Pain, Cannabis, Electromyography |
| Interventions | Cannabis Cream, Placebo Cream (Combination product) |
| Dates | start 2018-01-01, primary completion 2018-10-01, completion 2019-01-01, first posted 2019-06-21, last updated 2019-06-21 |
| Locations | 1 site in Poland |
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Evaluation of myorelaxant effect of cannabis cream.compared to placebo cream in topical skin application in patients with TMD
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Cannabis cream | Experimental | Combination Product: Cannabis Cream | Cannabis cream topical skin application in experimental group |
| Placebo cream | Placebo comparator | Combination Product: Placebo Cream | Placebo cream topical skin application in control group |
Sex: All, ages: 22 Years to 27 Years, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| Department of TMD Silesian Medical University | Zabrze | Poland |