Effect of an Analgesic Ointment on the Relief of Temporomandibular Joint and Masticatory Muscle Pain: a Randomized, Double Blinded, Placebo-controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- The Efficacy in the Treatment of TMJ and Muscle Pain
研究概览
简要总结
The purpose of this study is to compare the effectiveness of using topical cream of Ping On Ointment and using Vaseline cream in the treatment of temporomandibular joint (TMJ) and masticatory muscle pain, in order to establish the true efficacy of Ping On Ointment. Both Ping On Ointment and Vaseline are considered intervention.
详细描述
Aims: To compare the effectiveness of using topical cream of Ping On Ointment and using Vaseline cream in the treatment of temporomandibular joint (TMJ) and masticatory muscle pain, in order to establish the true efficacy of Ping On Ointment. Methods: In this randomized, double-blinded, placebo-controlled trial, 55 subjects with TMJ and/or masticatory pain (Group 1 patients according to the Research Diagnostic Criteria for Temporomandibular Disorder (RDC/TMD) received Ping On Ointment for 4 weeks; or placebo for 4 weeks. Subjects were evaluated with standard measures of efficacy: pain intensity measured by visual analogue scale and maximal comfortable mandibular opening, at baseline and again after 4 weeks of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Self report of facial ache or pain in the muscles of mastication, the TMJ, or the region in front of ear or inside the ear
- •Positive clinical diagnosis of TMDs. The TMD diagnosis is classified using axis I of the research diagnostic criteria ( RDC) for TMDs. The RDC diagnosis consists of joint pain at rest ( spontaneous pain) and evoked pain (hyperalgesia) on palpation of the TMJ, TMJ reduction consists of reciprocal clicking or joint noise with mandibular movement examination.
- •For joint pain complaint, subjects will be required to have a self-report of at least 1 month of daily or nearly-daily pain.
- •Subjects with myogenic pain will be included if they meet inclusion and exclusion criteria since patients with TMDs are known to exhibit muscle pain secondary to their joint dysfunction.
排除标准
- •Subjects with infectious arthritis, crystal induced arthropathies, musculoskeletal disorders, subjects with a primary diagnosis of myofascial pain based on the RDC;
- •Subjects with pain attributable to confirmed migraine or head pain condition other than tension headache;
- •Subjects with acute infection or other significant disease of teeth, ears, eyes, nose or throats; subjects with untreated depressive disorder or not on stable antidepressant medication for more than 6 months;
- •Subjects with dental diseases that required ongoing treatment, which would confound the evaluation of orofacial pain;
- •Subjects who are not competent in giving consents.
- •Pregnant or lactating women
- •Subjects with sensitivity to the ingredient of Ping On Ointment will be excluded.
研究组 & 干预措施
Ping On Ointment
Ping On Ointment
干预措施: Ping On Ointment (Drug)
Vaseline
Vaseline with minor trace of Ping On ointment to give medicinal smell
干预措施: Vaseline (Drug)
结局指标
主要结局
The Efficacy in the Treatment of TMJ and Muscle Pain
时间窗: 4 weeks
The efficacy in the treatment of TMJ and muscle pain is measured by a visual analogue scale (VAS). The VAS consists of a 100 mm line, anchored with the extremes of pain intensity represented as "no pain" ( 0 mm) and " worst pain possible" ( 100 mm).
次要结局
- The Mandibular Function.(4 weeks)
研究者
Wong Wing Kit, Ricky
Associate Professor, Orthodontics, Faculty of Dentistry
The University of Hong Kong