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

Primary Purpose

Other Disorders of Muscle in Diseases Classified Elsewhere

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Bee Venom Ointment
Vaseline Ointment
Sponsored by
Medical University of Silesia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Other Disorders of Muscle in Diseases Classified Elsewhere focused on measuring TMD, bee venom, muscle tension, muscle pain

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of TMD and Orthodontics Silesian Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bee Venom

Vaseline

Arm Description

Bee Venom Ointment 0,0005%

Vaseline ointment

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 25, 2014
Last Updated
December 7, 2017
Sponsor
Medical University of Silesia
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1. Study Identification

Unique Protocol Identification Number
NCT02101632
Brief Title
Myorelaxant Effect of Bee Venom(BV) Topical Skin Application in Patients With RDC/TMD Ia and Ib
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Silesia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Other Disorders of Muscle in Diseases Classified Elsewhere
Keywords
TMD, bee venom, muscle tension, muscle pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bee Venom
Arm Type
Experimental
Arm Description
Bee Venom Ointment 0,0005%
Arm Title
Vaseline
Arm Type
Placebo Comparator
Arm Description
Vaseline ointment
Intervention Type
Dietary Supplement
Intervention Name(s)
Bee Venom Ointment
Intervention Description
2 weeks
Intervention Type
Other
Intervention Name(s)
Vaseline Ointment
Intervention Description
2 weeks
Primary Outcome Measure Information:
Title
Masseter muscle tension
Description
Masseter muscle tension at rest and in maximal voluntary contraction, electromyographic measurement [V]
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Pain intensity of masseter muscle
Description
Pain intensity evaluation after 2 weeks of physiotherapy in visual analoque scale (VAS) scale
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Baron, Prof
Organizational Affiliation
Medical University of Silesia
Official's Role
Study Chair
Facility Information:
Facility Name
Department of TMD and Orthodontics Silesian Medical University
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
18955222
Citation
Hellner M, Winter D, von Georgi R, Munstedt 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.
Results Reference
background
PubMed Identifier
23365605
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.
Results Reference
background
PubMed Identifier
12031688
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. doi: 10.1016/s0024-3205(02)01617-x.
Results Reference
background
PubMed Identifier
17555825
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. doi: 10.1016/j.pharmthera.2007.04.004. Epub 2007 May 6.
Results Reference
background
PubMed Identifier
23317340
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.
Results Reference
background
PubMed Identifier
25050337
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.
Results Reference
derived

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

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