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

NCT ID: NCT06248866

Last Updated: 2024-02-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-10
• Study Completion Date: 2024-07-10

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

Conditions

Palmar Fibromatosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Extracorporeal Shock Wave Therapy

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

Group Type: EXPERIMENTAL

Extracorporeal Shock Wave Therapy

Intervention Type: OTHER

The affected hand or fingers will be positioned comfortably to ensure optimal access to the fibromatosis lesion. Gel or oil will be applied to the skin to enhance the transmission of shock waves. Shock wave therapy will be administered using the selected energy level and frequency settings. Energy level and frequency will be customized based on individual patient requirements. (1000-1500 shock/session, frequency between 5-12HZ, compression power of 1.5- 2.5 bars).and will receive traditional treatment

traditional treatment

Intervention Type: OTHER

the patients will receive traditional treatment in the form of laser (A low-level laser device with a wavelength of 830 nm and power output of 50 mW will be used as one Of the pain relief methods), ultrasound (An ultrasound device with a frequency of 1 MHz and an intensity of 1.5 W/cm² will be used), stretching and strengthening exercise and splinting.

traditional treatment

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

Group Type: ACTIVE_COMPARATOR

traditional treatment

Intervention Type: OTHER

the patients will receive traditional treatment in the form of laser (A low-level laser device with a wavelength of 830 nm and power output of 50 mW will be used as one Of the pain relief methods), ultrasound (An ultrasound device with a frequency of 1 MHz and an intensity of 1.5 W/cm² will be used), stretching and strengthening exercise and splinting.

Interventions

Extracorporeal Shock Wave Therapy

The affected hand or fingers will be positioned comfortably to ensure optimal access to the fibromatosis lesion. Gel or oil will be applied to the skin to enhance the transmission of shock waves. Shock wave therapy will be administered using the selected energy level and frequency settings. Energy level and frequency will be customized based on individual patient requirements. (1000-1500 shock/session, frequency between 5-12HZ, compression power of 1.5- 2.5 bars).and will receive traditional treatment

Intervention Type: OTHER

traditional treatment

the patients will receive traditional treatment in the form of laser (A low-level laser device with a wavelength of 830 nm and power output of 50 mW will be used as one Of the pain relief methods), ultrasound (An ultrasound device with a frequency of 1 MHz and an intensity of 1.5 W/cm² will be used), stretching and strengthening exercise and splinting.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Nabil Mahmoud Ismail Abdel-Aal

principle investigator nabil mahmoud ismail abdel-aal

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

nabil abdel-aal, professor

Role: CONTACT

nabil.mahmoud@cu.edu.eg

01080619880

mohamed soliman, spescialist

Role: CONTACT

abosma3il@yahoo.com

01111505351

Other Identifiers

P.T.REC/012/004965

Identifier Type: -

Identifier Source: org_study_id