Effect of Cryotherpy on Hypertrophic Scar
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- scar height
研究概览
简要总结
Purpose of the study:
The purpose of the study is to evaluate the therapeutic effect of cryotherpy in treating hypertrophic scar.
It will be hypothesized that:
Cryotherapy may not have an effect on hypertrophic scar.
详细描述
The potential of cryotherapy application in vitro data indicated that using freezing treatment on VFFs + TGF-β1 (myofibroblast) modulated ECM turnover toward antifibrosis and normalization, attenuated myofibroblast differentiation, reduced cell migration, and weakened the contractile activity. On both VFFs ± TGF-β1, freezing treatment raised LP regeneration (HAS1, decorin).
The findings indicate that cryotherapy may play a protective role in scar formation and contribute to lamina regeneration.
Furthermore the need of this study was developed from the lack in the quantitative knowledge and information in the published studies about the effect of cryotherapy on hypertrophic scar.
This study will be designed to provide a guideline about the effect of effect of cryotherapy on hypertrophic scar height, thickness and discoloration, and to assist in planning an ideal treatment regimen for reducing hypertrophic scar.
Delimitations:
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range between 20- 40 years.
- •Both sexes will participate in the study.
- •All patients participated will begin treatment program one month after injury depending on injury characteristics.
- •All patients enrolled to the study will have their informed consent.
排除标准
- •Diabetes mellitus.
- •Individuals with cardiopulmonary conditions.
- •Individuals undergoing radiation therapy or chemotherapy.
- •Hepatic or pancreatic diseases.
- •Sensory impairment
研究组 & 干预措施
Group A: (control group)
This group includes 30 patients will receive routine medical treatment and routine physical therapy as (Exercising, Positioning and splinting, Pressure Therapy and Massage).
干预措施: Exercising, Positioning and splinting, Pressure Therapy and Massage (Other)
Group B: (Study group)
This group includes 30 patients will receive cryotherapy (at least 10 minutes at -14 degree , 2 sessions per week , for 10 weeks ) in addition to routine medical and physical therapy treatment.
干预措施: cryotherapy (Gymna Cryoflow ICE-CT) (Device)
Group B: (Study group)
This group includes 30 patients will receive cryotherapy (at least 10 minutes at -14 degree , 2 sessions per week , for 10 weeks ) in addition to routine medical and physical therapy treatment.
干预措施: Exercising, Positioning and splinting, Pressure Therapy and Massage (Other)
结局指标
主要结局
scar height
时间窗: 3 months
The potential of cryotherapy application in vitro data indicated that using freezing treatment on scar decrease its height
次要结局
未报告次要终点
研究者
Zakria Mowafy
Professor of Physical Therapy for Surgery Faculty of Physical Therapy
Cairo University