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NCT Number: NCT02101632

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

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

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Key information

Conditions

Other Disorders of Muscle in Diseases Classified Elsewhere Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Myalgia Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of TMD and Orthodontics Silesian Medical University

Zabrze, 41-800, Poland

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bee Venom Ointment

Dietary Supplement

2 weeks

Vaseline Ointment

Other

2 weeks

Primary outcomes

  1. Masseter muscle tension

    Time frame: 2 weeks

    Masseter muscle tension at rest and in maximal voluntary contraction, electromyographic measurement [V]

Secondary outcomes

  1. Pain intensity of masseter muscle

    Time frame: 2 weeks

    Pain intensity evaluation after 2 weeks of physiotherapy in visual analoque scale (VAS) scale

Sponsors and collaborators

Lead sponsor

Medical University of Silesia

Other

Registry information

Official study 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

Acronym: BV/TMD

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 2, 2014
Registry last updated
Dec 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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