跳至主要内容
临床试验/CTRI/2024/06/068839
CTRI/2024/06/068839尚未招募4 期

A randomized controlled trial comparing the effectiveness of arthrocentesis alone, oral duloxetine alone, and a combination of both in the treatment of temporomandibular joint disorders.

Dr Damini Hiralal Nikhar1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2024年7月18日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
21
试验地点
1
主要终点
To evaluate the efficacy of arthrocentesis, oral duloxetine alone and combination of arthrocentesis with oral duloxetine in reducing pain in temporomandibular joint disorders.

研究概览

简要总结

Temporomandibular disorder (TMD) is a musculoskeletal disorder within the masticatory system. It has an adverse effect on jaw function so that patients may present with limited mouth opening or difficulty in chewing because of pain and locking in the temporomandibular joint (TMJ).

Most TMJ disorders include internal derangement which has been described as conditions in which the articular disc has become displaced from its original position in relation to the condylar head and articular eminence. The displacement of the disc can result in numerous presentations, with the most common being disc displacement with reduction (with or without intermittent locking) and disc displacement without reduction (with or without limited opening). TMJ disorder presents with symptoms like pain, joint sounds, and jaw function issues. Accurate diagnosis involves history, clinical examination, and imaging. Effective management is crucial to alleviate pain and maintain joint function.

Arthrocentesis is defined as a procedure in which the fluid in a joint cavity is aspirated with a needle and a therapeutic substance is injected. Duloxetine inhibits serotonin and norepinephrine reuptake, addressing central sensitization in chronic pain. In TMJ disorder, it reduces IL-6 production, easing inflammation and pain.

The purpose of this study is to evaluate the efficacy of arthrocentesis, oral duloxetine alone and combination of arthrocentesis with oral duloxetine in reducing pain and improving the maximum mouth opening in temporomandibular joint disorders.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Patient willing to participate in study.
  • 2.Patients in the age group of 18 -60 years.
  • 3.Patients diagnosed with TMJ arthralgia and intra articular TMJ disorders as given by DC TMD criteria.
  • 4.Patients with VAS score 5 or more pre-operatively.

排除标准

  • 1.Patients having systemic diseases in which duloxetine is contraindicated.
  • 2.Patients with coagulation disorders.
  • 3.Allergic reaction to local anesthetic agents and duloxetine.

结局指标

主要结局

To evaluate the efficacy of arthrocentesis, oral duloxetine alone and combination of arthrocentesis with oral duloxetine in reducing pain in temporomandibular joint disorders.

时间窗: VAS score at day1, day7, 1st month, 3rd month

次要结局

  • To evaluate the efficacy of arthrocentesis, oral duloxetine alone and combination of arthrocentesis with oral duloxetine in improving the maximum mouth opening in temporomandibular joint disorders(Maximum mouth opening at day1, day7, 1st month,3rd month)

研究者

发起方
Dr Damini Hiralal Nikhar
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Sanjay Joshi

Terna dental college and hospital

研究点 (1)

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