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临床试验/NCT01706172
NCT01706172已完成2 期

Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection: A Randomised Clinical Trial of Efficacy

Chisel Peak Medical Clinic1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2013年1月1日最近更新:
适应症
干预措施

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

Active Comparator

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

Active Comparator

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

发起方
Chisel Peak Medical Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. W Francois Louw

Clinical Instructor and Physician

University of British Columbia

研究点 (1)

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