Arthrocentesis Versus Botulinum Toxin Injection in Patients With Temporomandibular Joint Disorders: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 主要终点
- Change in Pain Intensity Measured by Visual Analog Scale (VAS)
研究概览
简要总结
The goal of this clinical trial is to learn if arthrocentesis works as well as botulinum toxin (Botox) injection to treat pain and jaw dysfunction in adults with temporomandibular joint (TMJ) disorders.
The main questions it aims to answer are:
- Does arthrocentesis reduce pain more, less, or the same as Botox injection?
- Does arthrocentesis improve jaw opening and function more, less, or the same as Botox injection?
- What side effects do participants have with each treatment?
Researchers will compare arthrocentesis to Botox injection to see which treatment works better for reducing pain and improving jaw movement in patients with TMJ disorders.
Participants will:
- Be randomly assigned to receive either arthrocentesis (a joint-washing procedure) or a Botox injection into the jaw muscles
- Visit the clinic at 1, 3, and 6 months after treatment for checkups and assessments - Rate their pain and have their jaw movement measured at each visit
- Complete short questionnaires about their jaw function and quality of life
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically and radiographically confirmed temporomandibular joint (TMJ) disorder, diagnosed according to Wilkes staging or the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD)
- •Age 18 years or older
- •Symptom duration of at least 3 months
- •Unresponsive to conservative therapy
- •Willing and able to provide written informed consent
排除标准
- •Previous TMJ surgery
- •Systemic rheumatic/inflammatory joint disease (e.g., rheumatoid arthritis, ankylosing spondylitis)
- •Bony ankylosis of the TMJ
- •Pregnancy
- •Known allergy or contraindication to botulinum toxin
- •Concurrent use of muscle relaxants, corticosteroids, or anticoagulant medication that may confound treatment effects
- •Unwillingness or inability to attend scheduled follow-up visits
结局指标
主要结局
Change in Pain Intensity Measured by Visual Analog Scale (VAS)
时间窗: Baseline, 1 month, 3 months, and 6 months post-treatment
Pain intensity in the temporomandibular joint region will be measured using a Visual Analog Scale (VAS), a 0-10 point continuous scale where 0 indicates no pain and 10 indicates the worst pain imaginable. Participants will rate their pain at rest and during jaw movement/chewing at each study visit. The change in VAS score from baseline to 6 months will be compared between the arthrocentesis and botulinum toxin injection groups.
次要结局
未报告次要终点
研究者
Mudher MB Alsunbuli
Assistant Professor Dr.
Al-Bayan University