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

Medical University of Silesia

Status and phase: Completed; Phase 3; Phase 2

Conditions: Cannabis; Temporomandibular Disorder; Myofascial Pain; Electromyography

Treatments: Combination Product: Cannabis Cream; Combination Product: Placebo Cream

Study type: Interventional

Funder types: Other

Identifiers

NCT03994640

Silesian UM Cannabis

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 22 to 27 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

20 participants in 2 patient groups, including a placebo group

Cannabis cream

Experimental group

Description:

Cannabis cream topical skin application in experimental group

Treatment:

Combination Product: Cannabis Cream

Placebo cream

Placebo Comparator group

Description:

Placebo cream topical skin application in control group

Treatment:

Combination Product: Placebo Cream