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Temporomandibular DisorderPhase 2/3NCT03994640

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

A Phase 2/3 study testing Cannabis Cream in people with Temporomandibular Disorder and Myofascial Pain, run by Medical University of Silesia at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Evaluation of myorelaxant effect of cannabis cream.compared to placebo cream in topical skin application in patients with TMD Read more about this study

Who is it for?
Ages 22 to 27 yearsHealthy volunteers can take part
What is being tested?
Cannabis Cream
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 sitePoland
Study dates
1 Jan 2018to 1 Jan 2019
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 to 27 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

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

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • Department of TMD Silesian Medical University

    Zabrze, 41-800

Other trials in Poland

About this study

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

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

Read the 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.

Being tested
Cannabis Cream, Placebo Cream
Keywords
temporomandibular disorder, Cannabis, Electromyography, Masticatory muscles, Topical application
Medical subject headings
Temporomandibular Joint Disorders, Marijuana Abuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cannabis CreamCombination product

    Also called Cannabis cream topical skin application

    Topical, bilateral skin application of cannabis cream with self-massage of masseter muscles

  • Placebo CreamCombination product

    Also called Placeo cream topical skin application

    Topical, bilteral skin application of placebo cream with self-massage of masseter muscles

Study groups in NCT03994640
Study groupRoleWhat they receive
Cannabis creamExperimentalCannabis cream topical skin application in experimental group
Receives: Combination Product: Cannabis Cream
Placebo creamPlacebo comparatorPlacebo cream topical skin application in control group
Receives: Combination Product: Placebo Cream

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reduction of sEMG activity of masseter muscle

    Reduction in masseter muscle electromyographic activity

    Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2019
  2. Study start1 Jan 2018
  3. Primary completion1 Oct 2018
  4. Study completion1 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
two groups parallel study: experimental and control group
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03994640
Sponsor's protocol ID
Silesian UM Cannabis
Status last verified
Jun 2019
First submitted
17 Jun 2019
Last updated
21 Jun 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 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.

    PubMed 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.

    PubMed 24482784

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Cannabis Cream in people with Temporomandibular Disorder and Myofascial Pain, run by Medical University of Silesia at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction of sEMG activity of masseter muscle (time frame: 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03994640, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2019.

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