Early Recovery After Surgery (ERAS)/Prehabilitation - Randomized Controlled Trial on the Implementation of ERAS/prehabilitation in Elective Reconstructive Shoulder Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Western Ontario Rotator Cuff Index (WORC)
研究概览
简要总结
The aim of this randomized controlled trial is to investigate whether the intervention can improve the clinical outcome and patient satisfaction in elective reconstructive shoulder surgeries. The study participants are adults with a diagnosed rotator cuff tear for which surgical treatment is planned. This main question is to be answered by the study:
• Does prehabilitation before elective shoulder surgeries lead to an improvement in postoperative outcomes and patient satisfaction compared to the control group?
The control group receives standard information about the hospital stay, while the intervention group undergoes the prehabilitation program in the approximately 6 weeks prior to surgery. This program includes:
- Information on the condition and pain management
- Recommendations for behavior modification
- A home exercise program Primary endpoint is the Western Ontario Rotator Cuff Index (WORC). The assessments are conducted at four time points: at study enrollment, immediately before surgery, and at 6, 12, and 24 months after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a traumatic or degenerative rupture of the rotator cuff with whom surgical treatment has been discussed in the shoulder clinic.
排除标准
- •Pre-existing fracture of the upper arm or shoulder girdle, rheumatic arthritis/fibromyalgia, additional findings in the shoulder joint (instability, frozen shoulder), neurological disease, cognitive or speech impairment
研究组 & 干预措施
Prehabilitation-Group
干预措施: Prehabilitation (Procedure)
Control-Group
干预措施: Control (Procedure)
结局指标
主要结局
Western Ontario Rotator Cuff Index (WORC)
时间窗: Inclusion in the study (T0), before surgery (T1); 6 months (T2), 12 months (T3) and 24 months (T4) after surgery
The WORC Index is a self-administered questionnaire designed to assess the quality of life in individuals with rotator cuff tendinopathy. It consists of 21 items across five domains: Physical Symptoms, Sports and Recreation, Work, Lifestyle, and Emotions. Each item is rated on a visual analogue scale (VAS) from 0 to 100. The total score ranges from 0 to 2100, which can be converted to a percentage for easier interpretation. A higher percentage indicates better shoulder function. The WORC Index is widely used in clinical settings to evaluate symptoms, functional limitations, and treatment outcomes.
次要结局
- Patient survey on Treatment satisfaction and willingness to recommend(before surgery (T1); 6 months (T2), 12 months (T3) and 24 months (T4) after surgery)
- EQ-5D quality of life questionnaire(Inclusion in the study (T0), before surgery (T1); 6 months (T2), 12 months (T3) and 24 months (T4) after surgery)
- Constant Murely score for self-evaluation(Inclusion in the study (T0), before surgery (T1); 6 months (T2), 12 months (T3) and 24 months (T4) after surgery)
- Subjective shoulder value(Inclusion in the study (T0), before surgery (T1); 6 months (T2), 12 months (T3) and 24 months (T4) after surgery)
- Survey on the use of painkillers(Inclusion in the study (T0), before surgery (T1); 6 months (T2), 12 months (T3) and 24 months (T4) after surgery)
- Survey on return to pre-operative sport(6 months (T2), 12 months (T3) and 24 months (T4) after surgery)
- Survey on return to preoperative occupation or daily responsibilities(6 months (T2), 12 months (T3) and 24 months (T4) after surgery)
- Examination for the presence of a re-rupture(6 months (T2), 12 months (T3) and 24 months (T4) after surgery)
研究者
Prof. Arasch Wafaisade
Prof. Dr. med.
University of Witten/Herdecke