COMPARISON STUY OF KINESIOTAPE AND LOW-LEVEL LASER THERAPY ON HYPERTROPHIC SCAR
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Schiotz Tonometer
研究概览
简要总结
Hypertrophic scars after burn injury often cause pain, stiffness, and cosmetic concerns. Kinesio taping (KT) and low-level laser therapy (LLLT; photobiomodulation) are widely used, yet direct comparisons and combined-therapy data remain limited. This single-center, three-arm, parallel randomized controlled trial will compare KT alone, LLLT alone, and their combination in patients with post-burn hypertrophic scars. Sixty participants will be randomized (1:1:1) to receive KT (reapplied every 2-3 days), LLLT using a 905-nm pulsed device (three sessions per week), or KT+LLLT for 8 weeks; all groups receive standardized scar care. Outcome assessors will be blinded. The primary outcome is change in scar pliability/firmness measured with a modified Schiotz tonometer from baseline to week 8. Secondary outcomes include change in pain intensity on a 10-cm visual analogue scale and treatment-related adverse events; an optional assessment at week 12 will evaluate durability. We hypothesize that KT+LLLT will produce greater improvements in elasticity and pain than either modality alone. The trial will be conducted at the Faculty of Physical Therapy, Cairo University (Giza, Egypt). Sponsor: Cairo University; Collaborators: National Institute of Laser Enhanced Sciences (NILES) and Faculty of Physical Therapy.
详细描述
Objective: Compare the effects of kinesio taping (KT), low-level laser therapy (LLLT), and their combination on pliability and pain of post-burn hypertrophic scars.
Design: Single-center, three-arm, parallel randomized controlled trial (1:1:1); assessor- and analyst-blinded.
Setting: Outpatient clinic, Faculty of Physical Therapy, Cairo University (Giza, Egypt).
Participants: ~60 patients with clinically diagnosed hypertrophic scars after burns; able to complete 8-week treatment; standard exclusions for open wounds, infection, photosensitivity, etc.
Interventions:
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
- Single (Outcomes Assessor)
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
- •Male or female patients aged between 10 and 30 years. Presence of clinically diagnosed hypertrophic scars secondary to burn injuries, occurring between two months and four years after complete wound healing No history of other systemic or local pathologies that could affect scar characteristics or response to treatment. Ability and willingness to comply with the treatment protocol and attend all scheduled sessions
排除标准
- •Open wounds or ulceration at or near the scarred area. Systemic medical conditions such as uncontrolled diabetes mellitus, cardiovascular disease, or a history of skin malignancy in the treatment region. Diagnosed deep vein thrombosis (DVT).Non-adherence, unwillingness to participate, or inability to follow the protocol. Cognitive impairment, psychiatric illness, or communication barriers affecting informed consent or participation.
结局指标
主要结局
Schiotz Tonometer
时间窗: Baseline (Week 0) ,Week 8.
The Riester Schiotz tonometer is used as an objective tool to assess hypertrophic scar elasticity The device displayed readings on a scale from 0 to 20. Indentation values were then converted to millimeters of mercury (mmHg) using a standardized conversion chart provided with the device
次要结局
- 2. Pain Assessment by Visual Analogue Scale (VAS)(Baseline (Week 0) , Week 8.)
研究者
Huda Badr Abd El Hamed
lecturer
Cairo University
