Palmar FibromatosisESWTNCT06248866
Effect Of Extracorporeal Shock Wave Therapy On Ultrasonography Changes In Patients With Palmar Fibromatosis: A Randomized Controlled Trial
A study testing Extracorporeal Shock Wave Therapy and traditional treatment in people with Palmar Fibromatosis, run by Cairo University at 1 site in Egypt.
Trial summary
this study will be conducted to investigate the effect of extracorporeal shock wave therapy on ultrasonography chnges In patients with palmar fibromatosis Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Palmar Fibromatosis
- What is being tested?
- Extracorporeal Shock Wave Therapy and traditional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Mar 2024to 19 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient clinic, ministry of health at sohag hospitals
Sohag, 82511
About this study
this study will be conducted to investigate the effect of extracorporeal shock wave therapy on ultrasonography chnges In patients with palmar fibromatosis
Read the 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
- Conditions
- Palmar Fibromatosis
- Being tested
- Extracorporeal Shock Wave Therapy, traditional treatment
- Keywords
- Extracorporeal Shock Wave Therapy, Ultrasonography Changes, Palmar Fibromatosis
- Medical subject headings
- Dupuytren Contracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Shock Wave TherapyOther
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 treatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Extracorporeal Shock Wave Therapy | Experimental | patients will receive Extracorporeal Shock Wave Therapy and traditional treatment three times a week for six weeks Receives: Other: Extracorporeal Shock Wave Therapy; Other: traditional treatment |
| traditional treatment | Active comparator | patients will receive traditional treatment three times a week for six weeks Receives: Other: traditional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
thickness of lesion
Ultrasonography will be used to assess the thickness of lesion
Measured: up to six weeks
Secondary outcomes (4)
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
Measured: up to six weeks
pressure pain threshold
algometer will be used to assess pressure pain threshold
Measured: up to six weeks
hand grip strength
Jamar hand held dynamometer will be used to assess hand grip strength
Measured: up to six weeks
finger range of motion
goniometer will be used to assess finger range of motion
Measured: up to six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start4 Mar 2024
- Primary completion19 Feb 2026
- Study completion19 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palmar FibromatosisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- extracorporeal shock wave therapy and traditional treatment
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nabil Mahmoud Ismail Abdel-Aal, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06248866
- Sponsor's protocol ID
- P.T.REC/012/004965
- Acronym
- ESWT
- Status last verified
- Jul 2026
- First submitted
- 31 Jan 2024
- Last updated
- 14 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Extracorporeal Shock Wave Therapy On Ultrasonography Changes In Patients With Palmar Fibromatosis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06248866
- Acronym / sponsor ID
- ESWT / P.T.REC/012/004965
- Conditions
- Palmar Fibromatosis
- Keywords
- Extracorporeal Shock Wave Therapy, Ultrasonography Changes, Palmar Fibromatosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 19 Feb 2026 (actual)
- Study completion
- 19 Feb 2026 (actual)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- extracorporeal shock wave therapy and traditional treatment
| Arm | Type | Receives |
|---|---|---|
| Extracorporeal Shock Wave Therapy | Experimental | Other: Extracorporeal Shock Wave Therapy, Other: traditional treatmentpatients will receive Extracorporeal Shock Wave Therapy and traditional treatment three times a week for six weeks |
| traditional treatment | Active comparator | Other: traditional treatmentpatients will receive traditional treatment three times a week for six weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal Shock Wave TherapyThe 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 | Extracorporeal Shock Wave Therapy |
| traditional treatmentthe 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. | Other | Extracorporeal Shock Wave Therapy, traditional treatment |
Primary outcome
thickness of lesion
Time frame: up to six weeks
Ultrasonography will be used to assess the thickness of lesion
4 secondary outcomes
Disabilities of the Arm, Shoulder, and Hand
Time frame: up to six weeks
pressure pain threshold
Time frame: up to six weeks
hand grip strength
Time frame: up to six weeks
finger range of motion
Time frame: up to six weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal Shock Wave Therapy and traditional treatment in people with Palmar Fibromatosis, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
thickness of lesion (time frame: up to six weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.