Clinical Evaluation of Kinesio Taping Outcomes in Stage II Cellulite: a Pilot Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Change in Low Echogenic Band (LEB) Thickness
研究概览
简要总结
The goal of this clinical trial is to evaluate whether kinesio taping can improve skin structure and reduce stage II cellulite in women. The study focuses on adult female participants aged 18-45 with stage II cellulite and normal BMI.
The main questions it aims to answer are:
Does kinesio taping increase dermis density? Does kinesio taping improve low echogenic band (LEB) thickness, an ultrasound marker of skin structure? Researchers will compare an experimental group receiving weekly fan-shaped kinesio tape applications on thighs and buttocks for four weeks to a control group that receives no intervention, to see if kinesio taping improves clinical and instrumental measures of cellulite.
Participants will:
Undergo baseline and follow-up assessments, including body composition, thigh circumference, cellulite stage scoring, and ultrasound of dermis density and LEB.
In the experimental group, receive kinesio taping applied once weekly for four weeks on the buttocks and thighs.
Return for re-evaluation immediately after the intervention and four weeks later.
详细描述
Cellulite is a common skin condition characterized by dimpling and irregular surface texture, primarily affecting women. It is associated with changes in the dermis and subcutaneous connective tissue, impaired microcirculation, and lymphatic congestion. Although not a disease, cellulite negatively impacts quality of life and has psychosocial consequences. Stage II cellulite, as defined by the Nürnberger-Müller Scale, presents with visible dimpling when standing, structural changes on palpation, and alterations detectable through imaging.
Kinesio taping (KT) is a non-invasive physiotherapy method widely used for musculoskeletal and circulatory conditions. Elastic tape is applied to the skin in specific patterns with the aim of lifting the epidermis, reducing local pressure, improving interstitial fluid flow, and enhancing lymphatic drainage. Based on these mechanisms, KT may be beneficial in the treatment of cellulite, particularly by improving dermal structure and promoting metabolic activity in subcutaneous fat. However, scientific evidence for KT in cellulite management remains scarce and inconsistent.
This pilot randomised controlled trial is designed to evaluate the short-term effects of kinesio taping on structural skin parameters in women with stage II cellulite. Thirty-four participants aged 18-45 years with normal body mass index and clinically confirmed stage II cellulite are randomly assigned to an experimental group or a control group. The experimental group receives fan-shaped kinesio tape applied once weekly for four weeks on the buttocks and thighs. The control group receives no intervention during the study period.
Primary outcomes include dermis density and low echogenic band (LEB) thickness measured using high-frequency ultrasound (DermaLab Combo 4). Secondary outcomes include cellulite stage scoring (Nürnberger-Müller Scale and Callegari Soft Plus), thigh circumference, body composition (fat percentage, fat mass, fat-free mass, basal metabolic rate, and total body water), and skin moisture. Measurements are taken at baseline, after four weeks of intervention, and four weeks post-intervention to assess residual effects.
The primary hypothesis is that kinesio taping will increase dermis density and LEB thickness compared with no intervention, indicating improved skin structure. Secondary hypotheses include potential reductions in thigh circumference and fat percentage and stabilization of skin hydration compared to the control 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
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •aged 18-45,
- •with Stage II cellulite,
- •normal BMI
排除标准
- •pregnancy,
- •thrombosis,
- •skin infections
结局指标
主要结局
Change in Low Echogenic Band (LEB) Thickness
时间窗: Baseline to 4 weeks (end of intervention).
LEB thickness, a subepidermal ultrasound marker of skin integrity and cellulite severity, will be measured using high-frequency ultrasound (DermaLab Combo 4).
Change in Dermis Density
时间窗: Baseline to 4 weeks (end of intervention).
Dermis density will be assessed using high-frequency ultrasound (DermaLab Combo 4) to evaluate changes in skin structure associated with cellulite.
次要结局
- Change in Thigh Circumference(Baseline to 4 weeks (end of intervention))
- Change in Body Fat Percentage(Baseline to 4 weeks (end of intervention))
- Change in Cellulite Severity (Callegari Soft Plus System)(Baseline to 4 weeks (end of intervention))
- Change in Fat Mass (kg)(Baseline to 4 weeks (end of intervention))
- Change in Fat-Free Mass (Kg)(Baseline to 4 weeks (end of intervention))
- Change in Basal Metabolic Rate (kcal/day)(Baseline to 4 weeks (end of intervention))
- Change in Cellulite Stage (Nürnberger-Müller Scale)(Baseline to 4 weeks (end of intervention))
- Change in Total Body Water (%)(Baseline to 4 weeks (end of intervention))