CLINICAL TRIAL: ENZYMATIC CAPSULOTOMY FOR ADHESIVE CAPSULITIS OF THE SHOULDER

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 本研究的目的是评价梭状芽胞杆菌胶原酶注射治疗原发性和继发性肩部粘连性囊炎(冻结肩)的相对安全性和有效性。研究的第一阶段将是第二阶段，开放标记，剂量反应调查。这将侧重于确定用于注射的安全有效剂量。之后，将使用先前开放标签研究确定的胶原酶临床有效剂量进行随机、安慰剂、双盲研究。疗效参数将基于美国肩肘外科医生协会的基本肩部评估表，该表对疼痛、运动、力量、稳定性、功能和患者满意度进行评级。预计将有10名患者参加试点剂量反应研究，约30-40名患者参加随机、安慰剂、双盲研究。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The goals of this study are to evaluate the relative safety and efficacy of Clostridial collagenase injection for both primary and secondary adhesive capsulitis of the shoulder (frozen shoulder). The first phase of study will be a phase II, open label, dose response investigation. This will focus on determination of a safe and effective dose to be used for injection. Following that, a random, placebo, double-blind study will be undertaken using the clinically effective dose of collagenase determined by the prior open label study. Efficacy parameters will be based on the American Society of Shoulder and Elbow Surgeons basic shoulder evaluation form which grades pain, motion, strength, stability, function and patient satisfaction. It is anticipated that ten patients will be enrolled in the pilot dose response study and approximately 30-40 patients in the random, placebo, double-blind study.