Conservative Treatment of Rotator Cuff Tear: The Role of Cycloergometer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 主要终点
- Visual Numeric Scale (VNS)
研究概览
简要总结
The cycloergometer is a mechanical device consisting of a bicycle frame fixed on a support base, designed to measure the amount of muscle work performed during exercise and the resistance to pedaling. The cycloergometer has been already employed in many fields of medicine.
However, up to date, a little use of cycloergometer in the management of chronic joint diseases has been documented and scientific studies have not clarified if cycloergometer is effective in these diseases and, particularly, in Rotator Cuff Tear patients.
详细描述
To evaluate the effects of cycloergometer on pain during activities (primary outcome) and shoulder functionality, the investigators performed a prospective randomized controlled study (pilot study) in patients with a symptomatic full-thickness RCT.
Since cycloergometer works through a continuous active and passive joint mobilization, the investigators expect it can reduce pain and improve shoulder functionality becoming a useful tool for physicians in the management of RCT patients.
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
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •positive imaging diagnosis of full-thickness RCT
- •surgery not considered as the first treatment of choice
- •willingness to sign the informed consent form.
排除标准
- •inflammatory rheumatic diseases
- •history of fracture or operations around the shoulder region
- •neurological diseases
- •infections or tumours
- •coagulation diseases
- •intra-articular injections of the involved shoulder within the last 12 months.
结局指标
主要结局
Visual Numeric Scale (VNS)
时间窗: Change from Baseline VNS at 6 months after the out-patient rehabilitation
The scale evaluated shoulder pain during activity
次要结局
- Health Assessment Questionnaire (HAQ)(Change from Baseline HAQ at 6 months after the out-patient rehabilitation)
- Constant-Murley scale(Change from Baseline Constant-Murley scale at 6 months after the out-patient rehabilitation)
研究者
Bernardo Gialanella
Doctor
Fondazione Salvatore Maugeri