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Clinical Trials/NCT06248866
NCT06248866
Not Yet Recruiting
N/A

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

Cairo University0 sites60 target enrollmentFebruary 10, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Palmar Fibromatosis
Sponsor
Cairo University
Enrollment
60
Primary Endpoint
thickness of lesion
Status
Not Yet Recruiting
Last Updated
2 years ago

Overview

Brief Summary

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

Detailed Description

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

Registry
clinicaltrials.gov
Start Date
February 10, 2024
End Date
July 10, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nabil Mahmoud Ismail Abdel-Aal

principle investigator nabil mahmoud ismail abdel-aal

Cairo University

Eligibility Criteria

Inclusion Criteria

  • 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).

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

thickness of lesion

Time Frame: up to six weeks

Ultrasonography will be used to assess the thickness of lesion

Secondary Outcomes

  • 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)

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