Randomized, Controlled, Within-patient, Singleblind Study to Evaluate the Efficacy of 12-weeks of Endermotherapy With Adult Burn Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Skin Thickness Changes
研究概览
简要总结
Mechanical massage or endermotherapyTM is applied to scar tissue with the intended therapeutic value being the promotion of structural or physiological changes. These proposed changes are meant to induce more pliability, so that skin possesses the strength and elasticity required for normal mobility. The advantage of mechanical massage compared to manual massage is that it provides a standard dosage using rollers and suction valves to mobilize the tissue. However, research documenting and supporting this effect is lacking. The objective of this proposal is to document the effect of 12 weeks of endermotherapy treatment on hypertrophic scar characteristics, including erythema, pigmentation, pliability, and thickness in adult burn survivors and their subjective evaluation of itch, pain and overall scar outcome through a prospective, randomized, controlled, within-patient, single-blinded study.
详细描述
Patients will receive 12 weeks of endermotherapy , 3 times a week.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •females and males, of any race, 14 years or older,
- •a thermal injury,
- •at least 3 months post-burn so that the scars will be durable enough to tolerate the proposed forces,
- •at least 2 scar sites >2.034 mm thick and within 0.5 mm of each other, and
- •signed the informed patient consent form
排除标准
- •subjects who have keloids,
- •with a diagnosis of psychiatric illness clearly documented in their medical file,
- •mechanism of injury is an electrical, chemical, or cold injury,
- •a dermatological conditions in the region of the evaluation site, that may interfere with the study results,
- •a suspected or known allergy to ultrasound gel,
- •unable to understand French or English, or
- •subjects who refuse to give informed consent.
结局指标
主要结局
Skin Thickness Changes
时间窗: baseline, 12, 24 and 36 weeks
Ultrasound skin measures, mm
次要结局
- Itch Visual Analog Subjective Changes(baseline, 12, 24 and 36 weeks)
- Cutometer Skin Elasticity Changes(baseline, 12, 24 and 36 weeks)
- Mexameter Skin Erythema Changes(baseline, 12, 24 and 36 weeks)
- Pain Visual Analog Subjective Changes: VAS(baseline, 12, 24 and 36 weeks)