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

NCT03994640 — Phase 2 / Phase 3, Completed, 20 participants, Medical University of Silesia

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

RegistryNCT03994640
StatusCompleted
PhasePhase 2 / Phase 3
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment20 (Actual)
SponsorMedical University of Silesia (Other)
ConditionsTemporomandibular Disorder, Myofascial Pain, Cannabis, Electromyography
InterventionsCannabis Cream, Placebo Cream (Combination product)
Datesstart 2018-01-01, primary completion 2018-10-01, completion 2019-01-01, first posted 2019-06-21, last updated 2019-06-21
Locations1 site in Poland

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-Summary

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

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Cannabis creamExperimentalCombination Product: Cannabis CreamCannabis cream topical skin application in experimental group
Placebo creamPlacebo comparatorCombination Product: Placebo CreamPlacebo cream topical skin application in control group
  • Cannabis Cream (Combination product), also known as Cannabis cream topical skin application: Topical, bilateral skin application of cannabis cream with self-massage of masseter muscles
  • Placebo Cream (Combination product), also known as Placeo cream topical skin application: Topical, bilteral skin application of placebo cream with self-massage of masseter muscles

+Outcome measures

Primary outcomes

  • Reduction of sEMG activity of masseter muscle [14 days]: Reduction in masseter muscle electromyographic activity

+Eligibility

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

+Locations (1)

FacilityCityCountryStatus
Department of TMD Silesian Medical UniversityZabrzePoland

+Publications

  • 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. doi: 10.1191/1352458504ms1048oa. PMID 15327040
  • 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 [RETIRED]: 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. PMID 24778283
  • 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. PMID 24482784

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