Myorelaxant Effect of Bee Venom(BV) Topical Skin Application in Patients With RDC/TMD Ia and Ib (BV/TMD)

Medical University of Silesia

Status: Completed

Conditions: Other Disorders of Muscle in Diseases Classified Elsewhere

Treatments: Dietary Supplement: Bee Venom Ointment; Other: Vaseline Ointment

Study type: Interventional

Funder types: Other

Identifiers

NCT02101632

2012/07/B/ST6/01238

Details and patient eligibility

About

Topical application of BV ointment in patients with Research Diagnostic Criteria/Temporomandibular Disorder 1a and 1b (RDC/TMD) in experimental group, compared to placebo (vaseline) in control group.Application was repeated 3 times a day, during 14 days. Surface electromyography (EMG) was used to measure masseter rest tonus and maximal voluntary contraction tonus. Pain intensity was also analysed in VAS scale. Effectiveness of BV was compared with placebo in masseter myofascial pain in patients with TMD

Full description

The aim of the study was evaluation of myorelaxant action of bee venom(BV) ointment, comparing to placebo.Parallel group, randomized double blinded trial was performed, including 79 patients with painful RDC/TMD 1a and 1b. Muscle tension was measured twice (TON1 and TON2) in rest muscle tonus (RMT) and maximal muscle contraction (MMC) on both sides right and left, with Easy Train Myo EMG (Version 3.1). Pain intensity was also analysed in VAS scale

Enrollment: 79 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• RDC/TMD 1a and 1b
• agreement to participate in the experimental study

Exclusion criteria

• bee venom allergy
• hyperactivity on bee products
• positive anamnesis of anaphylactic reaction after bee bites
• skin wounds with skin surface discontinuation
• RDC/TMD 2 and 3

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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79 participants in 2 patient groups, including a placebo group

Bee Venom

Experimental group

Description:

Bee Venom Ointment 0,0005%

Treatment:

Dietary Supplement: Bee Venom Ointment

Vaseline

Placebo Comparator group

Description:

Vaseline ointment

Treatment:

Other: Vaseline Ointment