The Effect of Postoperative Rehabilitation With a "Peanut Ball" After Total Knee Replacement. A Randomized Study Evaluating Postoperative Pain and Knee Function.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Visual analogue scale (VAS) (0-100)
研究概览
简要总结
The purpose of this randomized controlled study is to evaluate the effect of postoperative exercise with a "peanut ball" after total knee replacement, on pain, intake of pain killers, knee function, and health-related quality of life.
详细描述
After being informed about the study and potential risks, all patients giving written informed consent will be included in the study.
At baseline, before surgery, all patients will meet a nurse, a physical therapist, and an orthopedic doctor and answer questions about their health condition and do functional tests.
Each week is randomized to be either "peanut ball" or standard exercise week, with all patients during that week receiving the same treatment. Thus, depending on what week the patients are operated they will be mobilized with postoperative exercise with a "peanut ball" or to a standard exercise program (no peanut ball) 3-5 times/day for 6 weeks. All patients randomized to exercise with a "peanut ball" will receive a ball for free to bring home.
At the ward, the nurses will ask about the patient's pain level two times a day and register all medicines. The physical therapist will introduce the exercise and inform the patients to do the exercise 3-5 times/day a´ 15 minutes and fill in all exercises in an exercise diary.
2 weeks after surgery all patients have a standard visit to a nurse and a physical therapist at the orthopedic department. At this visit, the nurse will register the pain level and all intake of medicine and the physical therapist will measure the range of movement and the sit to stand test.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with osteoarthritis planned for surgery with total knee replacement at Skåne University Hospital.
排除标准
- •Patients who do not understand and talk the Swedish language
- •Patients with dementia
- •Revision surgery of the knee
- •Unicompartmentmental knee replacement
研究组 & 干预措施
Exercise with a "peanut ball".
The rehabilitation program consists of mobility- and functional training exercises with a "peanut ball".
干预措施: Exercise (Other)
Exercise without "peanut ball"
The rehabilitation program consists of standard mobility- and functional training exercises without a "peanut ball".
干预措施: Exercise (Other)
结局指标
主要结局
Visual analogue scale (VAS) (0-100)
时间窗: Change from baseline (before surgery) to 3 months after surgery
The scale is from 0-100 and a higher value is associated with more pain. 0:no pain and 100: most possible pain.
次要结局
- Forgotten Joint Score (FJS)(Change from baseline (before surgery) to 3 months after surgery.)
- Range of movement(Change from baseline (before surgery) to 3 months after surgery)
- Knee injury and Osteoarthritis Outcome Score (KOOS-12)(Change from baseline (before surgery) to 3 months after surgery.)
- Euro Qol-five dimensions, Visual analogue scale (EQ-5D VAS)(Change from baseline (before surgery) to 3 months after surgery.)
- 30 second sit to stand test(Change from baseline (before surgery) to 3 months after surgery.)