ENZYMATIC CAPSULOTOMY FOR ADHESIVE CAPSULITIS OF THE SHOULDER

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。本研究的目的是评估梭状芽孢杆菌胶原酶注射治疗原发性和继发性肩周炎（冻肩部）的相对安全性和有效性。第一阶段研究将是II期，开放标签，剂量反应调查。这将侧重于确定用于注射的安全有效剂量。随后，将进行随机、安慰剂、双盲研究，使用先前开放标签研究确定的胶原酶临床有效剂量。疗效参数将基于美国肩关节外科医师协会的基本肩关节评估表，对疼痛、运动、力量、稳定性、功能和患者满意度进行评分。预计10名患者将被纳入先导剂量反应研究，约30-40名患者将被纳入随机、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.