Effects on Shoulder Pain of Simulated Hyper-gravity During Rehabilitation Exercises
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Changes in pain level
研究概览
简要总结
Determine if adding "extra-gravity" (sustained increase in vertical loading) during standard rehabilitation exercises has a beneficial effect on pain reduction in subjects suffering from shoulder pain of different origin.
详细描述
Standard rehabilitation protocols will be used with every subject, depending on the cause of their shoulder pain. The treating clinician will determine the appropriate therapy protocol for each subject.
During the treatment sessions, subjects will wear a very comfortable waist belt attached with rubber band to anchor points on the ground (the rubber bands will be tighten to simulate the extra-gravity).
Upon enrollment, the treating clinician will randomly assign the subject to one of four groups depending on the type of loading and exercise typology.
The hyper-gravity will be simulated as an additional 50% of subject's body weight.
The frequency and duration of each therapy session will be determined by the treating clinician (usually 45 minutes of therapy twice a week for 4 weeks).
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of shoulder pain (potentially including rotator cuff pathology, impingement, bursitis, SLAP tear)
排除标准
- •adhesive capsulitis, fracture, dislocation, inflammatory arthritis, cancer, ligament disruption
研究组 & 干预措施
hypergravity WITHOUT isometric load
Patient performing rehabilitation exercises under hypergravity
干预措施: Hypergravity (Other)
hypergravity WITH isometric load
Patient performing rehabilitation exercises under hypergravity as well as loaded isometric squats
干预措施: Hypergravity (Other)
hypergravity WITH isometric load
Patient performing rehabilitation exercises under hypergravity as well as loaded isometric squats
干预措施: isometric load (Other)
normal gravity WITH isometric load
Patient performing rehabilitation exercises under normal gravity as well as loaded isometric squats
干预措施: isometric load (Other)
normal gravity WITH isometric load
Patient performing rehabilitation exercises under normal gravity as well as loaded isometric squats
干预措施: normal gravity (Other)
normal gravity WITHOUT isometric load
Patient performing rehabilitation exercises under normal gravity
干预措施: normal gravity (Other)
结局指标
主要结局
Changes in pain level
时间窗: three months
The patient will grade the pain level using a numeric pain scale (0 no pain; 10 unbearable pain requiring pain medication). Changes will be assessed between baseline (before therapy sessions) and three month post therapy. It will be used to investigate if there is any statistical difference between the different therapies.
次要结局
- Changes in Stability Score(three months)
- Changes in shoulder range of motion(three months)
- Changes in Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure(three months)
- Test of Sustained Selective Attention (TOSSA)(three months)
研究者
Frederick Carrick, PhD, FACCN
Principal investigator
Carrick Institute for Graduate Studies
