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Trial Title:
Effect Of Extracorporeal Shock Wave Therapy On Ultrasonography Changes In Patients With Palmar Fibromatosis: A Randomized Controlled Trial
NCT ID:
NCT06248866
Condition:
Palmar Fibromatosis
Conditions: Official terms:
Fibroma
Dupuytren Contracture
Conditions: Keywords:
Extracorporeal Shock Wave Therapy
Ultrasonography Changes
Palmar Fibromatosis
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
extracorporeal shock wave therapy and traditional treatment
Primary purpose:
Treatment
Masking:
Double (Investigator, Outcomes Assessor)
Masking description:
opaque sealed envelope
Intervention:
Intervention type:
Other
Intervention name:
Extracorporeal Shock Wave Therapy
Description:
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
Arm group label:
Extracorporeal Shock Wave Therapy
Intervention type:
Other
Intervention name:
traditional treatment
Description:
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.
Arm group label:
Extracorporeal Shock Wave Therapy
Arm group label:
traditional treatment
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
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Start date:
February 10, 2024
Completion date:
July 10, 2024
Lead sponsor:
Agency:
Cairo University
Agency class:
Other
Source:
Cairo University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06248866
