A Randomized Controlled Trial to Evaluate Effect of a Structured Rehabilitation Exercise Program on Facedown Posture-related Pain After Retinal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Final pain score at back neck, shoulder, and lower back
研究概览
简要总结
The purpose of this study is to evaluate the effects of a structured exercise program on musculoskeletal pain of patients in face-down posture after retinal surgery.
详细描述
After being informed about the study, patients who are planning to get vitrectomy for macular hole or retinal detachment are going to be randomly assigned into two groups; exercise group and control group. All patients are going be admitted to the hospital prior to the surgery. After the surgery is done, the patients are going to maintain a face-down position in the ward until postoperative day 3. After returning to the ward after surgery and completed the pain scoring forms, exercise training is going to be conducted for patients assigned to the exercise group by a physical therapist. Three times of daily self-exercise sessions are going to be performed according to the training provided to the patients. Pain score will be measured on the first, second and the third postoperative days. Patients will be discharged on the third postoperative days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Due to the nature of the interventions participants and researchers cannot be blinded to group allocation. The treating healthcare professionals (i.e. the Research Nurse and Clinical Research Fellow) will also not be masked due to nature of the service. The surgeon will be masked to allocation. The data manager and trial statistician will be masked to allocation throughout the study.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are getting vitrectomy for macular hole or retinal detachment and planning to maintain face-down posture.
排除标准
- •Pre-existing musculoskeletal disorder.
- •low visiual acuity in the opposite eye (best-corrected visual acuity less than 20/200 by snellen chart) making patients hard to get the exercise training.
- •Patients with posture prescriptions other than the prone position
结局指标
主要结局
Final pain score at back neck, shoulder, and lower back
时间窗: postoperative day 3
Pain score (numerical rating scale) at back neck, shoulder, and lower back at postoperative day 3 (discharge day). Possible scores range from 0 (no pain) to 10 (worst possible pain).
次要结局
- pain score at back neck, shoulder, and lower back on postoperative day 1(postoperative day 1)
- pain score at back neck, shoulder, and lower back on postoperative day 2(postoperative day 2)
- pain score at back neck, shoulder, and lower back right on surgery day(surgery day)
研究者
Se Woong, Kang
Professor
Samsung Medical Center