Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection: A Randomised Clinical Trial of Efficacy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Change from baseline to 3 months in Numerical Rating Scale (NRS) for Jaw Pain
研究概览
简要总结
Dysfunction of the jaw, associated with pain in the jaw or about the jaw in the face can be quite long lasting and debilitating. Dextrose injection with a small needle has been notably helpful in preliminary studies in reducing pain and improving jaw function. This randomized trial will compare dextrose injection with sterile water injection for temporomandibular(jaw) dysfunction, also known as TMD.
详细描述
Longitudinal studies of subjects with temporomandibular dysfunction show a general pattern of symptom diminishment, especially in the elderly. However studies out to 2-8 years show residual symptoms in many and nearly 25% with unabated symptoms. Dextrose injection has been utilized empirically for many years and a marked reduction in pain and luxation after intra-articular and pericapsular dextrose injection has been reported in a recent RCT. However, small study size and lack of a non injection control have prevented any definitive conclusions as the additional efficacy of including dextrose in the injectate. The mechanism of action of dextrose injection was originally thought to be via a brief stimulation of the inflammatory cascade with resultant production of growth factors. However, non-inflammatory dextrose effects on growth factor production have been demonstrated, and, more recently, dextrose has been found to treat neurogenic inflammation (pain from upregulation of the TRPV1 receptor on peptidergic nerves). This has the theoretical benefit of reducing pain, regardless of the status and position of the intraarticular cartilage or degree of degenerative change of the TMD. The primary goal of this study is to evaluate the ability of dextrose injection versus saline injection to reduce pain and improve functional complaints referable to the temporomandibular joint.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •more than 3 month history of :
- •Facial Pain NRS rating > 5/10
- •Jaw symptom rating > 5/10
- •Jaw function issues seen on examination
排除标准
- •Any potential acute dental issue
- •Rheumatic inflammatory disease
- •Chronic intake of NSAIDs or corticosteroids.
- •Pain in other body location worse than jaw pain
- •Pain 10/10 in other body location.
研究组 & 干预措施
Dextrose 20 % Injection
Injecting 20 % Dextrose and 0.2 % lidocaine intra-articularly into the TM Joint
干预措施: Injection of 20% dextrose/ 0.2% lidocaine (Other)
Sterile Water Injection
Injection of Sterile water in 0.2 % lidocaine intra-articularly into the TM joint
干预措施: Injection of 1 ml of 0.8 Sterile water /0.2% lidocaine (Other)
结局指标
主要结局
Change from baseline to 3 months in Numerical Rating Scale (NRS) for Jaw Pain
时间窗: 3 Months
TMJ injection of 20% dextrose will result in significantly more pain relief at 3 months than injection of .2% lidocaine.
次要结局
- Change from baseline to 3 months in Numerical Rating Scale (NRS) for Jaw Dysfunction.(3 Months)
- TMJ injection of 20% dextrose will result in sustainable improvement in Jaw Pain to 1 year follow-up.(1 year)
研究者
Dr. W Francois Louw
Clinical Instructor and Physician
University of British Columbia
