跳至主要内容
临床试验/NCT04044196
NCT04044196已完成不适用

Preoperative Psychological Risk Factors for the Retractable Capsulitis of the Shoulder After Shoulder Rotator Cuff Repair Surgery

Hospital Ambroise Paré Paris2 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2018年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
77
试验地点
2
主要终点
retractile capsulitis

研究概览

简要总结

The main objective of our study is to determine whether preoperative anxiety, depression and kinesiophobia are risk factors for retractile capsulitis after arthroscopic rotator cuff repair to best support these patients. patients postoperatively.

详细描述

The occurrence of a postoperative frozen shoulder after tendon repair of the rotator cuff of the shoulder is a devastating complication. It causes stiffness and slows down recovering. It associates a synovitis and a capsular retraction generating a transient but very incapacitating passive and active joint stiffness.

The evolution of capsulitis occurs in three phases:

  • The first phase or cold phase is distinguished mainly by pain. The stiffness settles gradually. This phase lasts 2 to 9 months
  • In the second phase or frozen phase lasting 4 to 12 months, the pain is less severe, but the rigidity is substantial.
  • In the third phase, the function is gradually recovered and the pain disappears. This phase can last up to two years.

Some patients will get back full mobility of their shoulder in 12 to 18 months, while others may have persistent symptoms for several months.

The International Society of Arthroscopy, Knee Surgery and Orthopedic Sports Medicine recently codified the clinical diagnosis: active anterior elevation less than 100 °, external rotation elbow to body less than 10 °, internal rotation less than L5.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient over 18 years old
  • Patient with rotator cuff rupture or subacromial conflict.
  • Free and enlightened non-opposition

排除标准

  • Pregnancy and breast feeding
  • Associated repair of the scapular tendon
  • Risk factors for capsulitis: diabetes, thyroid pathology, hypercholesterolemia, dupuytren's disease, homolateral breast surgery, history of myocardial infarction
  • Patient not affiliated to a social security scheme
  • Refusal of the patient

结局指标

主要结局

retractile capsulitis

时间窗: 6 months postoperatively

rate of patients with retractile capsulitis defined as active anterior elevation less than 100 °, external rotation elbow to body less than 10 °, internal rotation less than L5

次要结局

  • Numeric Pain Rating Scale(preoperatively and 6 months after surgery)
  • Hospital Anxiety and Depression Scale (HADS)(preoperatively and 6 months after surgery)
  • Tampa Scale for Kinesiophobia (TSK)(preoperatively and 6 months after surgery)
  • Constant shoulder score(preoperatively and 6 months after surgery)

研究者

发起方
Hospital Ambroise Paré Paris
申办方类型
Other
责任方
Principal Investigator
主要研究者

Shahnaz Klouche, MD

Clinical Research director

Hospital Ambroise Paré Paris

研究点 (2)

Loading locations...

相似试验