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

Other Disorders of Muscle in Diseases Classified Elsewhere Clinical Trial

— BV/TMD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02101632
• Other study ID #: 2012/07/B/ST6/01238
• Status: Completed
• Phase: N/A
• First received: March 25, 2014
• Last updated: December 7, 2017
• Start date: February 2014
• Est. completion date: March 2014

Study information

• Verified date: December 2017
• Source: Medical University of Silesia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscular Diseases
• Other Disorders of Muscle in Diseases Classified Elsewhere

Intervention

Dietary Supplement:
• Bee Venom Ointment
2 weeks

Other:
• Vaseline Ointment
2 weeks

Locations

Country	Name	City	State
Poland	Department of TMD and Orthodontics Silesian Medical University	Zabrze

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Silesia

Country where clinical trial is conducted

Poland, 

References & Publications (5)

Hellner M, Winter D, von Georgi R, Münstedt K. Apitherapy: usage and experience in german beekeepers. Evid Based Complement Alternat Med. 2008 Dec;5(4):475-9. doi: 10.1093/ecam/nem052. Epub 2007 Jun 30. — View Citation

Kwon YB, Lee HJ, Han HJ, Mar WC, Kang SK, Yoon OB, Beitz AJ, Lee JH. The water-soluble fraction of bee venom produces antinociceptive and anti-inflammatory effects on rheumatoid arthritis in rats. Life Sci. 2002 May 31;71(2):191-204. — View Citation

Seo BK, Lee JH, Sung WS, Song EM, Jo DJ. Bee venom acupuncture for the treatment of chronic low back pain: study protocol for a randomized, double-blinded, sham-controlled trial. Trials. 2013 Jan 14;14:16. doi: 10.1186/1745-6215-14-16. — View Citation

Son DJ, Lee JW, Lee YH, Song HS, Lee CK, Hong JT. Therapeutic application of anti-arthritis, pain-releasing, and anti-cancer effects of bee venom and its constituent compounds. Pharmacol Ther. 2007 Aug;115(2):246-70. Epub 2007 May 6. Review. — View Citation

Wieckiewicz W, Miernik M, Wieckiewicz M, Morawiec T. Does propolis help to maintain oral health? Evid Based Complement Alternat Med. 2013;2013:351062. doi: 10.1155/2013/351062. Epub 2013 Jan 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Masseter muscle tension	Masseter muscle tension at rest and in maximal voluntary contraction, electromyographic measurement [V]	2 weeks
Secondary	Pain intensity of masseter muscle	Pain intensity evaluation after 2 weeks of physiotherapy in visual analoque scale (VAS) scale	2 weeks