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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Masseter muscle tension
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •RDC/TMD 1a and 1b
- •agreement to participate in the experimental study
排除标准
- •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
研究组 & 干预措施
Bee Venom
Bee Venom Ointment 0,0005%
干预措施: Bee Venom Ointment (Dietary Supplement)
Vaseline
Vaseline ointment
干预措施: Vaseline Ointment (Other)
结局指标
主要结局
Masseter muscle tension
时间窗: 2 weeks
Masseter muscle tension at rest and in maximal voluntary contraction, electromyographic measurement \[V\]
次要结局
- Pain intensity of masseter muscle(2 weeks)
研究者
Aleksandra Nitecka-Buchta
D.M.D.
Medical University of Silesia