Botulinum Toxin in the Management of Temporo-mandibular Related Myalgia: a Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change from baseline in the mean pain rated with the VAS at 1, 3 and 6 months
研究概览
简要总结
The aim of this study was to evaluate the clinical course in terms of pain, function and quality of life of patients with TMD-related myalgia during six months after receiving BTX-A injections. The research question was: What are the outcomes in pain, quality of life and function of patients with TMD-related myalgia receiving BTX-A during 6 months? The hypothesis to be tested was that patients receiving a BTX-A injection due to TMD-related myalgia will have a reduction in pain and increase in quality of life and function after one, three- and six- months.
详细描述
This is a prospective and observational cohort study. The Medical Research Ethics Committees United provided a non-WMO (Medical Research Involving Human Subject Acts) waiver (W23.212) prior to commencement of this study. All participants will be informed and most give their written consent prior to participating, according the requirements of the Declaration of Helsinki (World Medical Association, 2013).
Participants Participants in this study are adults with TMD-related myalgia according to the DC/TMD treated with a BTX-A injection. All participants are recruited at the department of Oral and Maxillofacial Surgery (OMS) of the Diakonessenhuis, Utrecht, The Netherlands.
Inclusion criteria for participation are:
- TMD-related myalgia in accordance with the DC/TMD;
- Accepted BTX-A injections as treatment;
- Age ≥ 18 years;
- Understanding of the Dutch language to fill in the questionnaires.
Exclusion criteria for participation are:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •TMD-related myalgia in accordance with the DC/TMD;
- •Accepted BTX-A injections as treatment;
- •Age ≥ 18 years;
- •Understanding of the Dutch language to fill in the questionnaires.
排除标准
- •Systemic inflammatory and connective tissue diseases (e.g., rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis);
- •Surgery in the TMJ area < 12 months ago;
- •Pain of dental origin;
- •Limited cognitive functioning (not allowed to make medical decisions);
- •Use of muscle relaxants, or aminoglycoside antibiotics;
- •A history of allergic reactions to BTX;
- •Pregnancy and lactation.
结局指标
主要结局
Change from baseline in the mean pain rated with the VAS at 1, 3 and 6 months
时间窗: Baseline, 1, 3 and 6 months
The VAS will be used to measure pain intensity. The VAS consists of a 100 mm line, with two set points, 0 (indicating no pain) and 10 (indicating worst imaginable pain).
次要结局
- Change from baseline in the mean oral health related quality of life rated with the OHIP-14 at 1, 3 and 6 months(Baseline, 1, 3 and 6 months)
- Change from baseline in mean mandibular function rated by the MFIQ at 1, 3, and 6 months(Baseline, 1, 3 and 6 months)
- Change from baseline in the mean maximal active and passive mouth opening at 1, 3 and 6 months(Baseline, 1, 3 and 6 months)