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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06248866
Acronym
ESWT
Enrollment
60
Registered
2024-02-08
Start date
2024-03-04
Completion date
2026-02-19
Last updated
2026-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Palmar Fibromatosis

Keywords

Extracorporeal Shock Wave Therapy, Ultrasonography Changes, Palmar Fibromatosis

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

Interventions

OTHERExtracorporeal 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

OTHERtraditional 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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

opaque sealed envelope

Intervention model description

extracorporeal shock wave therapy and traditional treatment

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
thickness of lesionup to six weeksUltrasonography will be used to assess the thickness of lesion

Secondary

MeasureTime frameDescription
Disabilities of the Arm, Shoulder, and Handup to six weeksThe 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
pressure pain thresholdup to six weeksalgometer will be used to assess pressure pain threshold
hand grip strengthup to six weeksJamar hand held dynamometer will be used to assess hand grip strength
finger range of motionup to six weeksgoniometer will be used to assess finger range of motion

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 15, 2026