Clinical trial NCT02101632: Myorelaxant Effect of Bee Venom(BV) Topical Skin Application in Patients With RDC/TMD Ia and Ib
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Other Disorders of Muscle in Diseases Classified Elsewhere
Keywords: TMD
bee venom
muscle tension
muscle pain
Lead sponsor: Medical University of Silesia
Sponsor class: OTHER
First posted: 2014-04-02
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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

Primary outcomes:
measure: Masseter muscle tension
timeFrame: 2 weeks
Secondary outcomes:
measure: Pain intensity of masseter muscle
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Zabrze
country: Poland
facility: Department of TMD and Orthodontics Silesian Medical University
Study officials:
affiliation: Medical University of Silesia
name: Stefan Baron, Prof
role: STUDY_CHAIR
References:
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citation: Nitecka-Buchta A, Buchta P, Tabenska-Bosakowska E, Walczynska-Dragon K, Baron S. Myorelaxant effect of bee venom topical skin application in patients with RDC/TMD Ia and RDC/TMD Ib: a randomized, double blinded study. Biomed Res Int. 2014;2014:296053. doi: 10.1155/2014/296053. Epub 2014 Jun 24.