CLINICAL TRIAL: ENZYMATIC CAPSULOTOMY FOR ADHESIVE CAPSULITIS OF THE SHOULDER

该子项目是利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个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，不一定是研究者的机构。 本研究的目的是评价梭菌胶原酶注射液治疗原发性和继发性粘连性肩关节囊炎（冻结肩）的相对安全性和有效性。 研究的第一阶段将是II期、开放标签、剂量反应研究。 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。 有效性参数将基于美国肩肘外科医师协会基本肩关节评价表，该表对疼痛、活动、力量、稳定性、功能和患者满意度进行分级。 预计10例患者将入组初步剂量反应研究，约30-40例患者将入组随机、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.