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

Not Applicable

Completed

• Conditions: Other Disorders of Muscle in Diseases Classified Elsewhere
• Interventions: Dietary Supplement: Bee Venom Ointment; Other: Vaseline Ointment

• Registration Number: NCT02101632
• Lead Sponsor: Medical University of Silesia

Brief Summary

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

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

Study Timeline

• Study Start: 2014-02
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Study First Submitted: 2014-03-25
• Study First Submitted QC: 2014-03-28
• Study First Posted: 2014-04-02
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-07
• Last Update Posted: 2017-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bee Venom	Bee Venom Ointment	Bee Venom Ointment 0,0005%
Vaseline	Vaseline Ointment	Vaseline ointment

Primary Outcome Measures

Name	Time	Method
Masseter muscle tension	2 weeks	Masseter muscle tension at rest and in maximal voluntary contraction, electromyographic measurement \[V\]

Secondary Outcome Measures

Name	Time	Method
Pain intensity of masseter muscle	2 weeks	Pain intensity evaluation after 2 weeks of physiotherapy in visual analoque scale (VAS) scale

Trial Locations

Locations (1)

Department of TMD and Orthodontics Silesian Medical University; 🇵🇱 Zabrze, Poland