Clinical trial NCT06248866: Effect Of Extracorporeal Shock Wave Therapy On Ultrasonography Changes In Patients With Palmar Fibromatosis: A Randomized Controlled Trial
Official title: Effect Of Extracorporeal Shock Wave Therapy On Ultrasonography Changes In Patients With Palmar Fibromatosis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Palmar Fibromatosis
Keywords: Extracorporeal Shock Wave Therapy
Ultrasonography Changes
Palmar Fibromatosis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: extracorporeal shock wave therapy and traditional treatment
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: thickness of lesion
timeFrame: up to six weeks
Secondary outcomes:
measure: Disabilities of the Arm, Shoulder, and Hand
timeFrame: up to six weeks
measure: pressure pain threshold
timeFrame: up to six weeks
measure: hand grip strength
timeFrame: up to six weeks
measure: finger range of motion
timeFrame: up to six weeks
Other outcomes:
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