CLINICAL TRIAL: ENZYMATIC CAPSULOTOMY FOR ADHESIVE CAPSULITIS OF THE SHOULDER

临床试验：酶促肩关节囊切开术治疗肩部粘连性肩关节囊炎

• 批准号: 7950775
• 负责人: MARIE A BADALAMENTE
• 金额: $ 0.43万
• 依托单位: STATE UNIVERSITY NEW YORK STONY BROOK
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-12-01 至 2009-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7950775
• 关键词: Adhesive Capsulitis; American; Client satisfaction; Clinical Research; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Dose; Double-Blind Method; Elbow; Enrollment; Evaluation; Freezing; Funding; Goals; Grant; Injection of therapeutic agent; Institution; Investigation; Motion; Pain; Patients; Phase; Placebos; Relative (related person); Research; Research Personnel; Resources; Safety; Shoulder; Societies; Source; Surgeon; United States National Institutes of Health; base; collagenase; open label; response

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.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 本研究的目的是评估梭菌胶原酶注射液治疗原发性和继发性肩关节囊粘连炎（肩周炎）的相对安全性和有效性。 第一阶段的研究将是第二阶段、开放标签、剂量反应研究。 这将集中于确定用于注射的安全有效剂量。 随后，将使用先前开放标签研究确定的临床有效剂量的胶原酶进行随机、安慰剂、双盲研究。 功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分。 预计将有 10 名患者参加试点剂量反应研究，大约 30-40 名患者将参加随机、安慰剂、双盲研究。