Ultrasound in Combination With Manual Therapy in the Treatment of Ischemic Digital Ulcers in Systemic Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- functional capacity
研究概览
简要总结
The objective of this before-after non-randomized trial study is to evaluate the efficacy of ultrasound therapy in combination with manual therapy in the management of systemic sclerosis patients with IDU. The main questions it intends to answer are:
• Is this combination of treatments effective in these patients in terms of improvement in hand functional ability, pain relief, injury healing, and quality of life?
Participants will receive rehabilitation treatment consisting of a combination of manual therapy (McMennel joint manipulation, pumping, and connective tissue massage) and US water immersion. The researchers will compare the group of participants, called the treatment group, with a control group to see if:
• Is the combined treatment of ultrasound therapy and manual therapy more effective in these patients than manual therapy alone?
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of SSc according to the ACR and EULAR criteria
- •presence of IDU in active phase
- •naïve to rehabilitation treatment for their hands and upper limbs
- •written in-formed consent to participate in the study.
排除标准
- •presence of skin lesions due to other conditions (e.g., trauma);
- •pregnancy;
- •infectious diseases (e.g. HIV, HBV, HCV);
- •myositis;
- •arthritis;
- •other rheumatological diseases and immunodepression.
结局指标
主要结局
functional capacity
时间窗: after 4 weeks of treatment
Duruoz's hand index. The total score ranges from 0-90 with higher scores indicating poorer hand functioning.
次要结局
- disease-related quality of life(after 4 weeks of treatment)
- ulcer assessment(after 4 weeks of treatment)
- pain intensity(after 4 weeks of treatment)
研究者
Prof.ssa Giulia Letizia Mauro
Professor
University of Palermo