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

NCT ID: NCT02101632

Last Updated: 2017-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-03-31

Brief Summary

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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

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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

Conditions

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Other Disorders of Muscle in Diseases Classified Elsewhere

Keywords

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TMD bee venom muscle tension muscle pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Bee Venom

Bee Venom Ointment 0,0005%

Group Type EXPERIMENTAL

Bee Venom Ointment

Intervention Type DIETARY_SUPPLEMENT

2 weeks

Vaseline

Vaseline ointment

Group Type PLACEBO_COMPARATOR

Vaseline Ointment

Intervention Type OTHER

2 weeks

Interventions

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Bee Venom Ointment

2 weeks

Intervention Type DIETARY_SUPPLEMENT

Vaseline Ointment

2 weeks

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Silesia

OTHER

Sponsor Role lead

Responsible Party

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Aleksandra Nitecka-Buchta

D.M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stefan Baron, Prof

Role: STUDY_CHAIR

Medical University of Silesia

Locations

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Department of TMD and Orthodontics Silesian Medical University

Zabrze, , Poland

Site Status

Countries

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Poland

References

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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.

Reference Type BACKGROUND
PMID: 18955222 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23365605 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12031688 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17555825 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23317340 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25050337 (View on PubMed)

Other Identifiers

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2012/07/B/ST6/01238

Identifier Type: -

Identifier Source: org_study_id