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

NCT06248866 | Completed

• 1 other identifier: P.T.REC/012/004965
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Palmar Fibromatosis

Keywords

Extracorporeal Shock Wave Therapy; Ultrasonography Changes; Palmar Fibromatosis

Outcome Measures

Primary Outcomes (1)

• thickness of lesion

  Ultrasonography will be used to assess the thickness of lesion

  up to six weeks

Secondary Outcomes (4)

• Disabilities of the Arm, Shoulder, and Hand

  up to six weeks

• pressure pain threshold

  up to six weeks

• hand grip strength

  up to six weeks

• finger range of motion

  up to six weeks

Study Arms (2)

Extracorporeal Shock Wave Therapy

EXPERIMENTAL

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

Other: Extracorporeal Shock Wave Therapy; Other: traditional treatment

traditional treatment

ACTIVE COMPARATOR

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

Other: traditional treatment

Interventions

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

Extracorporeal Shock Wave Therapy

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.

Extracorporeal Shock Wave Therapy; traditional treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Outpatient clinic, ministry of health at sohag hospitals

Sohag, 82511, Egypt

Location

MeSH Terms

Conditions

Dupuytren Contracture

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: opaque sealed envelope
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator nabil mahmoud ismail abdel-aal

Model Details: extracorporeal shock wave therapy and traditional treatment

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 8, 2024
• Study Start: March 4, 2024
• Primary Completion: February 19, 2026
• Study Completion: February 19, 2026
• Last Updated: July 14, 2026

Record last verified: 2026-07

Locations

EG (1)