Other Disorders of Muscle in Diseases Classified ElsewhereBV/TMDNCT02101632
Myorelaxant Effect of Bee Venom(BV) Topical Skin Application in Patients With RDC/TMD Ia and Ib
A study testing Bee Venom Ointment and Vaseline Ointment in people with Other Disorders of Muscle in Diseases Classified Elsewhere, run by Medical University of Silesia at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Other Disorders of Muscle in Diseases Classified Elsewhere
- What is being tested?
- Bee Venom Ointment and Vaseline Ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 sitePoland
- Study dates
- Feb 2014to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- RDC/TMD 1a and 1b
- agreement to participate in the experimental study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of TMD and Orthodontics Silesian Medical University
Zabrze, 41-800
About this study
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
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
Read the 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
- Being tested
- Bee Venom Ointment, Vaseline Ointment
- Keywords
- TMD, bee venom, muscle tension, muscle pain
- Medical subject headings
- Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bee Venom OintmentDietary supplement
2 weeks
Vaseline OintmentOther
2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Bee Venom | Experimental | Bee Venom Ointment 0,0005% Receives: Dietary Supplement: Bee Venom Ointment |
| Vaseline | Placebo comparator | Vaseline ointment Receives: Other: Vaseline Ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Masseter muscle tension
Masseter muscle tension at rest and in maximal voluntary contraction, electromyographic measurement [V]
Measured: 2 weeks
Secondary outcomes (1)
Pain intensity of masseter muscle
Pain intensity evaluation after 2 weeks of physiotherapy in visual analoque scale (VAS) scale
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2014 (estimated)
- Study startFeb 2014
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Other Disorders of Muscle in Diseases Classified ElsewhereStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleksandra Nitecka-Buchta, Medical University of Silesia
- Investigators
- Stefan Baron, Prof, Study chair, Medical University of Silesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02101632
- Sponsor's protocol ID
- 2012/07/B/ST6/01238
- Acronym
- BV/TMD
- Status last verified
- Dec 2017
- First submitted
- 25 Mar 2014
- Last updated
- 11 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18955222Wieckiewicz 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.
PubMed 23365605Kwon 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.
PubMed 12031688Son 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.
PubMed 17555825Seo 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.
PubMed 23317340Nitecka-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.
PubMed 25050337
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02101632
- Acronym / sponsor ID
- BV/TMD / 2012/07/B/ST6/01238
- Keywords
- TMD, bee venom, muscle tension, muscle pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 2 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bee Venom | Experimental | Dietary Supplement: Bee Venom OintmentBee Venom Ointment 0,0005% |
| Vaseline | Placebo comparator | Other: Vaseline OintmentVaseline ointment |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- RDC/TMD 1a and 1b
- agreement to participate in the experimental study
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bee Venom Ointment2 weeks | Dietary supplement | Bee Venom |
| Vaseline Ointment2 weeks | Other | Vaseline |
Primary outcome
Masseter muscle tension
Time frame: 2 weeks
Masseter muscle tension at rest and in maximal voluntary contraction, electromyographic measurement [V]
1 secondary outcome
Pain intensity of masseter muscle
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2017.
- Background: PubMed 18955222Hellner 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.
- Background: PubMed 23365605Wieckiewicz 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.
- Background: PubMed 12031688Kwon 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.
- Background: PubMed 17555825Son 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.
- Background: PubMed 23317340Seo 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.
- Derived from this study: PubMed 25050337Nitecka-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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Baron, Prof study chair
Medical University of Silesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bee Venom Ointment and Vaseline Ointment in people with Other Disorders of Muscle in Diseases Classified Elsewhere, run by Medical University of Silesia at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Masseter muscle tension (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02101632, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2017.