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NCT Number: NCT06248866

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

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

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Key information

Conditions

Palmar Fibromatosis Connective Tissue Diseases Contracture Dupuytren Contracture Fibroma Muscular Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Fibrous Tissue Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Outpatient clinic, ministry of health at sohag hospitals

Sohag, 82511, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Extracorporeal Shock Wave Therapy

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

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.

Primary outcomes

  1. thickness of lesion

    Time frame: up to six weeks

    Ultrasonography will be used to assess the thickness of lesion

Secondary outcomes

  1. Disabilities of the Arm, Shoulder, and Hand

    Time frame: up to six weeks

    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

  2. pressure pain threshold

    Time frame: up to six weeks

    algometer will be used to assess pressure pain threshold

  3. hand grip strength

    Time frame: up to six weeks

    Jamar hand held dynamometer will be used to assess hand grip strength

  4. finger range of motion

    Time frame: up to six weeks

    goniometer will be used to assess finger range of motion

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Acronym: ESWT

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 8, 2024
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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