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Trial record 2 of 2 for:    cannabis, marihuana | Fibromyalgia

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03994640
Recruitment Status : Completed
First Posted : June 21, 2019
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
Aleksandra Nitecka-Buchta, Medical University of Silesia

Tracking Information
First Submitted Date  ICMJE June 17, 2019
First Posted Date  ICMJE June 21, 2019
Last Update Posted Date June 21, 2019
Actual Study Start Date  ICMJE January 1, 2018
Actual Primary Completion Date October 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2019)
Reduction of sEMG activity of masseter muscle [ Time Frame: 14 days ]
Reduction in masseter muscle electromyographic activity
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Myorelaxant Effect of Cannabis Cream Topical Skin Application in Patients With TMD
Official Title  ICMJE Myorelaxant Effect of Cannabis Cream Topical Skin Application in Patients With Temporomandibular Disorders: a Randomized, Double-blind Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
two groups parallel study: experimental and control group
Masking: Double (Participant, Care Provider)
Masking Description:
double blind study: for patients and researchers
Primary Purpose: Treatment
Condition  ICMJE
  • Temporomandibular Disorder
  • Myofascial Pain
  • Cannabis
  • Electromyography
Intervention  ICMJE
  • Combination Product: Cannabis Cream
    Topical, bilateral skin application of cannabis cream with self-massage of masseter muscles
    Other Name: Cannabis cream topical skin application
  • Combination Product: Placebo Cream
    Topical, bilteral skin application of placebo cream with self-massage of masseter muscles
    Other Name: Placeo cream topical skin application
Study Arms  ICMJE
  • Experimental: Cannabis cream
    Cannabis cream topical skin application in experimental group
    Intervention: Combination Product: Cannabis Cream
  • Placebo Comparator: Placebo cream
    Placebo cream topical skin application in control group
    Intervention: Combination Product: Placebo Cream
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 20, 2019)
20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 1, 2019
Actual Primary Completion Date October 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years to 27 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03994640
Other Study ID Numbers  ICMJE Silesian UM Cannabis
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Aleksandra Nitecka-Buchta, Medical University of Silesia
Study Sponsor  ICMJE Medical University of Silesia
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Medical University of Silesia
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP