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临床试验/NCT06248866
NCT06248866已完成不适用

Effect Of Extracorporeal Shock Wave Therapy On Ultrasonography Changes In Patients With Palmar Fibromatosis: A Randomized Controlled Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3月4日最近更新:
适应症
干预措施

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
thickness of lesion

研究概览

简要总结

this study will be conducted to investigate the effect of extracorporeal shock wave therapy on ultrasonography chnges In patients with palmar fibromatosis

详细描述

Palmar fibromatosis, also known as Dupuytren's contracture, is a condition that affects the hand and fingers. It is characterized by the thickening and tightening of the fascia, a layer of connective tissue beneath the skin of the palm. This thickening and tightening can lead to the formation of nodules or cords that restrict the movement of the affected fingers. The treatment options for palmar fibromatosis vary depending on the severity of the condition and its impact on hand function. Mild cases may not require immediate treatment but should be regularly monitored. However, if the symptoms worsen or hinder hand function, there are several treatment options available. Extracorporeal shock wave therapy (ESWT) is a non-invasive physical therapy procedure that uses high-energy sound waves to treat various musculoskeletal conditions. It is commonly used to manage pain and promote healing in conditions such as plantar fasciitis, tendinitis, calcific tendinitis, and other similar disorders The ESWT has shown promising results in reducing pain, improving function, and promoting healing in various musculoskeletal conditions. sixty patients with palmar fibromatosis will be assigned randomly to two groups; first one will receive extracorporeal shock wave with traditional therapy and the other one will receive traditional therapy only

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)

盲法说明

opaque sealed envelope

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with palmar fibromatosis.
  • Adults aged 18 to 70 years.
  • Patients of any stage of physiological change of the disease (nodules cords and contractures).

排除标准

  • Patients with contraindications to extracorporeal shock wave therapy.
  • Patients with a history of previous surgery for palmar fibromatosis.
  • Patients with comorbidities or conditions that may affect the outcomes of the study.
  • Patients of ganglions and palmar tendon fibrosis.
  • Patients of sever and morbid obesity.
  • End stage disease with psychological disturbance nature.
  • Pregnant women.
  • Cardiac and pulmonary unstable patients may affect results.

研究组 & 干预措施

Extracorporeal Shock Wave Therapy

Experimental

patients will receive Extracorporeal Shock Wave Therapy and traditional treatment three times a week for six weeks

干预措施: Extracorporeal Shock Wave Therapy (Other)

Extracorporeal Shock Wave Therapy

Experimental

patients will receive Extracorporeal Shock Wave Therapy and traditional treatment three times a week for six weeks

干预措施: traditional treatment (Other)

traditional treatment

Active Comparator

patients will receive traditional treatment three times a week for six weeks

干预措施: traditional treatment (Other)

结局指标

主要结局

thickness of lesion

时间窗: up to six weeks

Ultrasonography will be used to assess the thickness of lesion

次要结局

  • pressure pain threshold(up to six weeks)
  • finger range of motion(up to six weeks)
  • Disabilities of the Arm, Shoulder, and Hand(up to six weeks)
  • hand grip strength(up to six weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nabil Mahmoud Ismail Abdel-Aal

principle investigator nabil mahmoud ismail abdel-aal

Cairo University

研究点 (1)

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