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

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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Myorelaxant Effect of Bee Venom(BV) Topical Skin Application in Patients With Research Diagnostic Criteria/Temporomandibular Disorder Ia and Ib (RDC/TMD) Randomized, Double Blinded Study

Conditions
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Other Disorders of Muscle in Diseases Classified Elsewhere

Intervention / Treatment
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* Dietary Supplement: Bee Venom Ointment
* Other: Vaseline Ointment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bee Venom<br>Bee Venom Ointment 0,0005% | Dietary Supplement: Bee Venom Ointment<br>* 2 weeks<br>|
| Placebo Comparator: Vaseline<br>Vaseline ointment | Other: Vaseline Ointment<br>* 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Masseter muscle tension | Masseter muscle tension at rest and in maximal voluntary contraction, electromyographic measurement [V] | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity of masseter muscle | Pain intensity evaluation after 2 weeks of physiotherapy in visual analoque scale (VAS) scale | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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muscle tension, TMD, bee venom, muscle pain