Myorelaxant Effect of Cannabis Cream Topical Skin Application in Patients With TMD
Primary Purpose
Temporomandibular Disorder, Myofascial Pain, Cannabis
Status
Completed
Phase
Phase 2
Locations
Poland
Study Type
Interventional
Intervention
Cannabis Cream
Placebo Cream
Sponsored by
About this trial
This is an interventional treatment trial for Temporomandibular Disorder focused on measuring temporomandibular disorder, Cannabis, Electromyography, Masticatory muscles, Topical application
Eligibility Criteria
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
Sites / Locations
- Department of TMD Silesian Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Cannabis cream
Placebo cream
Arm Description
Cannabis cream topical skin application in experimental group
Placebo cream topical skin application in control group
Outcomes
Primary Outcome Measures
Reduction of sEMG activity of masseter muscle
Reduction in masseter muscle electromyographic activity
Secondary Outcome Measures
Full Information
NCT ID
NCT03994640
First Posted
June 17, 2019
Last Updated
June 20, 2019
Sponsor
Medical University of Silesia
1. Study Identification
Unique Protocol Identification Number
NCT03994640
Brief Title
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
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
October 1, 2018 (Actual)
Study Completion Date
January 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Silesia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorder, Myofascial Pain, Cannabis, Electromyography
Keywords
temporomandibular disorder, Cannabis, Electromyography, Masticatory muscles, Topical application
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
two groups parallel study: experimental and control group
Masking
ParticipantCare Provider
Masking Description
double blind study: for patients and researchers
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cannabis cream
Arm Type
Experimental
Arm Description
Cannabis cream topical skin application in experimental group
Arm Title
Placebo cream
Arm Type
Placebo Comparator
Arm Description
Placebo cream topical skin application in control group
Intervention Type
Combination Product
Intervention Name(s)
Cannabis Cream
Other Intervention Name(s)
Cannabis cream topical skin application
Intervention Description
Topical, bilateral skin application of cannabis cream with self-massage of masseter muscles
Intervention Type
Combination Product
Intervention Name(s)
Placebo Cream
Other Intervention Name(s)
Placeo cream topical skin application
Intervention Description
Topical, bilteral skin application of placebo cream with self-massage of masseter muscles
Primary Outcome Measure Information:
Title
Reduction of sEMG activity of masseter muscle
Description
Reduction in masseter muscle electromyographic activity
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
27 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Department of TMD Silesian Medical University
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
15327040
Citation
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.
Results Reference
background
PubMed Identifier
24778283
Citation
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: 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.
Results Reference
background
PubMed Identifier
24482784
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.
Results Reference
background
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Myorelaxant Effect of Cannabis Cream Topical Skin Application in Patients With TMD
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