A Double Blind Randomised Study Comparing Hyaluronic Acid, Corticosteroid and Placebo During Arthrocentesis for Temporomandibular Joint Dysfunction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 5
- 主要终点
- Change in Pain Between Baseline and Month 1 Scores
研究概览
简要总结
The purpose of this study is to determine whether the administration of hyaluronic acid or corticosteroid during arthrocentesis of the temporomandibular joint provides additional pain relief and improved function.
The overall hypothesis for the study is that hyalgan will result in a 30% reduction in the mean visual analogue scale (VAS) at one month when compared to celestone and placebo.
详细描述
This study will enroll patients with temporomandibular joint dysfunction who are deemed appropriate candidates for irrigation of their jaw joints secondary to pain or limited opening. At the completion of the joint irrigation subjects will be injected by one of three different products to determine if the additional injection results in a further decrease in jaw joint pain and improved opening. Subjects will be followed for 3 months. Those who do not show improvement may be candidates for additional treatment.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age greater than 18 years
- •arthralgia of one or both temporomandibular joints
- •Wilkes II to IV internal derangement of the symptomatic joint OR
- •limited opening of <35 mm
排除标准
- •myofascial pain as the primary source of pain
- •cervical pain as the primary source of pain
- •systemic arthropathy
- •fibromyalgia
- •use of NSAIDS within 48 hours
- •allergy to study medications
- •edentulous subjects
- •pregnancy or breast feeding
- •current physical therapy, muscle relaxants or antiseizure medications
- •current use of a splint issued within last 12 weeks
研究组 & 干预措施
Hyaluronic acid
干预措施: Hyaluronic acid (Drug)
Corticosteroid
干预措施: Corticosteroid (Drug)
Saline
干预措施: Lactated Ringers (Drug)
结局指标
主要结局
Change in Pain Between Baseline and Month 1 Scores
时间窗: Baseline (preoperation), Month 1
The change in pain level was assessed using a single-item visual analogue pain scale at Baseline (preoperatively) and at Month 1. Participants indicate their level on pain on a scale of 0 (no pain) to 10 (worst pain imaginable). The right and left side of each participant's jaw was evaluated separately. The change in pain score was obtained by subtracting the Month 1 score from the Baseline score and a negative value indicates a reduction in pain level.
次要结局
- Change in Maximum Incisal Opening (MIO) Between Baseline, Month 1, and Month 3(Baseline (preoperation), Month 1, Month 3)
- Jaw Function Limitation Scale (JFLS) Score(Month 3)
研究者
Gary F Bouloux MD, DDS, MDSc, FRACDS, FRACDS
National PI
Emory University