Evaluation of Pain Regression in Patients With Myofascial Facial Pain Treated by Dextrose Prolotherapy Versus Local Anesthetic Injections: A Prospective Double-blind Randomized Placebo-controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 主要终点
- Patients' subjective pain experience
研究概览
简要总结
The aim of this study is to compare the treatment effects of dextrose prolotherapy, saline, and mepivacaine for deactivating myofascial trigger points within the jaw muscles.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Presence of active myofacial pains in jaw muscles, previously identified by manual palpation.
- •Age ≥ 18 years.
- •Willingness to follow instructions
排除标准
- •Therapeutic intervention for myofascial pain within the past month before the study, such as using of medications for pain control or wearing of occlusal splint.
- •Clinical conditions such as pregnancy.
- •Medical problems that may interfere with the procedures such as bleeding disorders, trigeminal neuralgia.
- •Recent facial or neck trauma; medication or adjunctive treatment (eg, physiotherapy) that could not be stopped during the study; or allergy to local anesthetic solutions.
- •Cognitive impairment or exhibited inadequate cooperation.
结局指标
主要结局
Patients' subjective pain experience
时间窗: one year
Pressure pain threshold (PPT): An algometer will be used to assess PPT. The algometer consists of a 1 cm2 rubber tipped plunger mounted on a force transducer. The pressure will be applied over the examined trigger point. The participants will be instructed to point when the sensation changed from pressure to pain. The mean of three trials will be calculated and used for analysis.
次要结局
未报告次要终点
研究者
Alaa Ahmed Mohamed Ammar
Principal Investigator, Internal resident in Oral and Maxillofacial Department, faculty of oral and dental medicine.
Cairo University