Effect of Extracorporeal Shock Wave Therapy on Chronic Neurogenic Heterotopic Ossification in Traumatic Brain Injured Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in Visual Analogue Scale (VAS) from baseline to final assessment
研究概览
简要总结
Effect of Extracorporeal Shock Wave Therapy on Chronic Neurogenic Heterotopic Ossification in Traumatic Brain Injured (TBI) patients
Chronic Neurogenic Heterotopic Ossification (NHO) - Heterotopic ossification is a well known late complication of traumatic brain injury. Extracorporeal Shock Wave Therapy - ESWT- is used in various medical situations and is being tested for feasibility of use in TBI patients.
详细描述
PROTOCOL SYNOPSIS Title Effect of Extracorporeal Shock Wave Therapy on Chronic Neurogenic Heterotopic Ossification in Traumatic Brain Injured (TBI) patients.
The investigators primary objective is to determine whether Extracorporeal Shock Wave Therapy (ESWT) is effective in reducing pain and improving function in people with traumatic brain injury who have heterotopic ossification around the hip or knee.
The investigators hypothesize that four applications of ESWT to the affected hip or knee joint in the patient group will demonstrate a positive physiological effect and this will lead to a reduction in pain and improved function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Brain injured patients with a diagnosis of NHO around the hip and/ or knee for a period of greater than one year.
- •Patients who are able, or legal guardians who are willing, to provide informed consent after both oral and written information.
排除标准
- •Pregnancy.
- •Rheumatoid arthritis, ankylosing spondylitis, or femoral neck fractures
- •Elevated serum alkaline phosphatase (SAP) levels and/or evidence of active bone remodelling in bone scan
结局指标
主要结局
Change in Visual Analogue Scale (VAS) from baseline to final assessment
时间窗: VAS will be assessed at two weekly intervals from week 0 (Baseline) until week 22, at week 26 and at week 38.
The Visual Analogue Pain Scale (VAS) will be used in its format of the Faces Rating Scale (FRS). The FRS is in the format of six facial expressions suggesting various pain intensities. The patient will be asked to choose the face that best describes how they feel. The far left face indicates 'No hurt' and the far right face indicates 'Hurts worst'. The number below the face chosen will be documented.
次要结局
- Change from the 10 Metre Walk at baseline (if patient is ambulatory)(At baseline; weeks 16, 26 and 38)
- Change from Modified Functional Reach at baseline (if FR not possible)(Every two weeks from date of baseline, week 0 up to week 22; then at week 26 and at week 38)
- Change from the 6 Minute Walk at baseline (if patient is ambulatory)(At baseline; weeks 16, 26 and 38)
- Change from Functional Reach at baseline (if patient is able to stand)(Every two weeks from date of baseline, week 0 up to week 22; then at week 26 and at week 38)
研究者
yaron sacher
Yaron Sacher M.D
Loewenstein Hospital