Pulsed High Intensity Laser Versus Extracorporeal Shockwave Therapy on Hypertrophic Scar Post Burn
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Modified Vancouver burn Scar assessment scale
研究概览
简要总结
The goal of this clinical trial stydy : is to compare between the effect of pulsed high intensity laser and extracorporeal shockwave therapy on hypertrophic scar on post burned patients.
The main questions is it aims to answer is :
- Which is more effective on hypertrophic scar post burn Extracorporeal shockwave therapy or pulsed high intensity laser therapy?
- Participants will receive the treatment for 6 weeks.
- Assesment will be don before and after treatment.
详细描述
- Subjects :
Sixty patients have hypertrophic scar post burn. They will be selected from El Gamaa hospital and randomly distributed into two equal groups. Their ages will be ranged from 20 to 45 years. 2. Design of the study :
In this study, the patients will be randomly divided into two equal groups in number (30 patients each).
- Group A (pulsed high intensity laser group):
In this group of the study, thirty patients whom have hypertrophic scar post burn injury will receive pulsed high intensity laser in addition to traditional physiotherapy (deep friction massage and stretching exercises) for six weeks. The application will be three times per week. 2. Group B (Extracorporeal shockwave group):
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
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The patients age will range from 20 to 45 years.
- •All patients will be free from any other pathological conditions or histories except hypertrophic scar.
- •patients will be selected from both gender.
- •All patients will have hypertrophic scars post burn injuries.
排除标准
- •The patients who have open wound at or near treatment site.
- •The patients who have cardiac pacemakers or other implanted electronic devices.
- •The patients who have any significant health problem such as diabetes, circulatory
- •disorders or history of skin malignancy in the treated area.
- •uncooperative patients.
- •The patients who have a deep venous thrombosis (DVT).
研究组 & 干预措施
study group receives pulsed high intensity laser and coservative treatment
干预措施: pulsed high intensity laser therapy (Device)
study group receives extracorporeal shockwave therapy and coservative treatment
干预措施: Extracorporeal shockwave therapy (Device)
结局指标
主要结局
Modified Vancouver burn Scar assessment scale
时间窗: change of the total score from the begginning of the treatment to the end of the treatment (after 6 weeks from the begginning of the treatment)
Modified Vancouver scar scale , an observer-dependent scale of the macroscopic appearance of scarring, is used to measure changes in the scar over the period of treatment,The Modified Vancouver Scar Scale score is probably the most widely known scar scale that consists of three components (vascularization, pliability and scar height); the total score ranges from 0 to 11, with 0 representing normal skin ,Scoring; vascularity ranged from 0 to 3 (1 Pink, 2 Red, 3 Purple), pliability ranged from 0 to 5 (1 Supple, 2 Yielding, 3 Firm, 4 Ropes, 5 Contracture) and height ranged from 0 to 3 (1 Less than 2 mm, 2 From 2 to 5 mm, 3 More than 5 mm). The larger the total score, the worse the HTS. The investigators choose an algebraic value for any of these characteristics based on a comparison with normal skin (zero score).
次要结局
- Aschiotz tonometer device(change of the hypertrohic scar pressure score from the begginning of the treatment to the end of the treatment (after 6 weeks from the begginning of the treatment))
研究者
Amira Fayed Ali Ibrahim
physiotherapist
Cairo University