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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Palmar Fibromatosis
• Intervention / Treatment: Other: Extracorporeal Shock Wave Therapy; Other: traditional treatment

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: nabil abdel-aal, professor; Phone Number: 01080619880; Email: nabil.mahmoud@cu.edu.eg
• Study Contact Backup: Name: mohamed soliman, spescialist; Phone Number: 01111505351; Email: abosma3il@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Extracorporeal Shock Wave Therapy; patients will receive Extracorporeal Shock Wave Therapy and traditional treatment three times a week for six weeks	Other: 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; 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.
Active Comparator: traditional treatment; patients will receive traditional treatment three times a week for six weeks	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
thickness of lesion	Ultrasonography will be used to assess the thickness of lesion	up to six weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disabilities of the Arm, Shoulder, and Hand	The Arabic version of the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire will be administered to evaluate functional outcomes.The questionnaire consists of 11 items related to daily activities and symptoms. Each item is rated on a 5-point Likert scale, with higher scores indicating greater disability	up to six weeks
pressure pain threshold	algometer will be used to assess pressure pain threshold	up to six weeks
hand grip strength	Jamar hand held dynamometer will be used to assess hand grip strength	up to six weeks
finger range of motion	goniometer will be used to assess finger range of motion	up to six weeks

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): February 10, 2024
• Primary Completion (Estimated): July 10, 2024
• Study Completion (Estimated): July 10, 2024

Study Registration Dates

• First Submitted: January 31, 2024
• First Submitted That Met QC Criteria: January 31, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Extracorporeal Shock Wave Therapy; Ultrasonography Changes; Palmar Fibromatosis
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Musculoskeletal Diseases; Connective Tissue Diseases; Muscular Diseases; Neoplasms, Connective Tissue; Neoplasms, Fibrous Tissue; Contracture; Fibroma; Dupuytren Contracture
• Other Study ID Numbers: P.T.REC/012/004965

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No