Comparative Evaluation Study of Retro Discal Tissue Injection Arthroscopically Versus Ultrasound Guide Injection
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pain intensity (VAS)
研究概览
简要总结
A comparative evaluation study of arthroscopic retrodiscal tissue injection versus ultrasound-guided injection in temporomandibular joint disorders aims to assess differences in pain relief, functional improvement, and clinical outcomes between an invasive and a minimally invasive delivery technique. Arthroscopic injection allows direct visualization of intra-articular structures, accurate targeting of the retrodiscal tissues, and simultaneous management of associated pathology such as synovitis or adhesions, which may enhance therapeutic outcomes in advanced internal derangement. In contrast, ultrasound-guided injection offers a less invasive, cost-effective, and outpatient-based approach with improved accuracy over blind techniques, making it suitable for early or moderate cases. While both methods are effective in reducing pain and improving mouth opening and jaw function, arthroscopic injection may provide superior results in patients requiring diagnostic confirmation and mechanical intervention, whereas ultrasound-guided injection offers comparable symptomatic improvement with lower procedural morbidity and resource utilization.
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
- 15 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18-60 years with symptomatic TMJ disorder/internal derangement (unilateral or bilateral)
- •TMJ pain at rest and/or during function for ≥ 3 months
- •Clinical diagnosis consistent with disc displacement with or without reduction (with or without MRI confirmation, if included in the protocol)
- •Baseline pain intensity ≥ 4/10 on VAS or NRS
- •Limitation of mouth opening or functional impairment (e.g., maximum mouth opening ≤ 35 mm or pain-related limitation)
- •Failed or insufficient response to conservative therapy for ≥ 4-6 weeks (e.g., soft diet, NSAIDs, splint therapy, physiotherapy)
- •Ability to provide informed consent and comply with scheduled follow-up visits
排除标准
- •Previous TMJ surgery (arthroscopy or arthrotomy) on the study side or TMJ injection within the last 3-6 months
- •TMJ ankylosis, fracture, tumor, or active infection
- •Primary inflammatory arthropathy (e.g., rheumatoid arthritis, gout, psoriatic arthritis) or systemic connective tissue disease affecting the TMJ
- •Significant degenerative joint disease (advanced osteoarthritis) if the study focuses on internal derangement or soft tissue pathology
- •Severe skeletal or dentofacial deformity requiring orthognathic surgery during the study period
- •Pregnancy or lactation
- •Bleeding disorders, platelet disorders, or anticoagulant therapy that cannot be safely managed (particularly relevant for PRP injections)
- •Known allergy or contraindication to the planned injectate or local anesthetic
- •Severe uncontrolled systemic disease (ASA III-IV) or inability to tolerate anesthesia or sedation (for arthroscopy arm)
- •Active psychiatric or neurologic condition that may impair accurate pain reporting or follow-up compliance
结局指标
主要结局
Pain intensity (VAS)
时间窗: Baseline → 2 months (early outcome) Baseline → 6 months (mid-term outcome)
Change in TMJ pain score measured on a 10-cm Visual Analogue Scale (0 = no pain, 10 = worst pain) from baseline to 3 months post-intervention.
次要结局
未报告次要终点
研究者
Wajmah Sayed Karim Al Sayed
Principal Investigator, PhD Candidate
Cairo University