Effect Of Extracorporeal Shock Wave Therapy On Ultrasonography Changes In Patients With Palmar Fibromatosis: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cairo University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- thickness of lesion
Study 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
opaque sealed envelope
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Extracorporeal Shock Wave Therapy
patients will receive Extracorporeal Shock Wave Therapy and traditional treatment three times a week for six weeks
Intervention: Extracorporeal Shock Wave Therapy (Other)
Extracorporeal Shock Wave Therapy
patients will receive Extracorporeal Shock Wave Therapy and traditional treatment three times a week for six weeks
Intervention: traditional treatment (Other)
traditional treatment
patients will receive traditional treatment three times a week for six weeks
Intervention: traditional treatment (Other)
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)
Investigators
Nabil Mahmoud Ismail Abdel-Aal
principle investigator nabil mahmoud ismail abdel-aal
Cairo University