- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07443371
Effect of Transfer Energy Capacitive and Resistive Therapy on Palmar Fibromatosis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Dupuytren contracture is a benign, progressive disease of the palmar fascia which results in shortening, thickening, and fibrosis of the fascia and aponeurosis of the palm driven by myofibroblastic proliferation.
TECAR therapy is considered a special form of energy that uses frequencies between 300 KHz and 1 MHz and is characterized as a non-invasive high-frequency energy that awakens the body's natural ability to self-regenerate.
The TECAR therapy can work in two modes of electric charge transfer: capacitive and resistive mode. The reactions produced by the capacitive system through the capacitive electrode are focused on tissues with higher electrolyte content, such as soft tissues and muscles, as opposed to the resistive system that focuses on larger and more resistant tissues such as tendons, bones and articulations. With these two modes of energy transfer, the therapy allows an increase in vasodilation, oxygenation, increase in microcirculation and increase in internal temperature. So, this study aimed to to explore the effect of Transfer Energy Capacitive and Resistive Therapy (TECAR) therapy on pain, range of motion (ROM) and hand function in dupuytren's contracture patients (palmar fibromatosis).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Peter Haroun, Master
- Phone Number: 01289951508
- Email: DpTpeter2019@gmail.com
Study Contact Backup
- Name: Ahmed Zarraa, PHD
- Phone Number: 01007580084
- Email: dptahmedzarraa91@gmail.com
Study Locations
-
-
-
Cairo, Egypt
- Peter Milad Haroun
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Ages of patients will be ranged from 40 to 70 years.
- Presence of palpable cords and/or digital contracture ≥ 20° at the metacarpophalengeal joint or Proximal interphalengeal joint joints .
- Clinical diagnosis confirmed by a hand surgeon or relevant specialist.
- All patients will enter the study having their informed consent
Exclusion Criteria:
- Patient with severe contracture >30° or multiple digit involvement requiring surger.
- History of surgical release (fasciotomy, fasciectomy) or collagenase injection in the affected hand.
- Presence of infection, ulceration, or skin lesions on the treatment area.
- Presence of pacemakers, metal implants, or other electronic implants in the treatment area.
- Active cancer or tumor in the treatment region.
- Pregnancy.
- Conditions such as stroke, Parkinson's disease, or rheumatoid arthritis that may confound results.
- Cognitive impairment, psychiatric illness, or other barriers to protocol adherence
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Transfer Energy Capacitive and Resistive (TECAR) therapy
The patients will receive Tecar therapy, in addition to traditional therapy for 6 weeks
|
The apparatus used is comprised of a generator that supplies a signal at the frequency of 0.5 MHz and a maximum power of 300 watts (HCR900).The power can be regulated by controlling the quantity of transferred energy and the relative biological action. The counter electrode (Return Plate) that closes the circuit consists of a metal plate that is applied in opposition or a cylinder that is clasped. The head of the device will be applied over the treated area for 20 minutes (min) (10 min of capacitive head and 10 min of resistive head), moderate to high intensity. It will be applied along and in circles over the affected palm, 3 sessions weekly for 6 weeks. The patients will receive the traditional physical therapy program 3 sessions / week , for 6 weeks totally. It consists of stretching exercise, flexor tendon glide and splinting. |
|
Active Comparator: Traditional therapy group
The patients will receive traditional therapy only for 6 weeks .
|
The patients will receive the traditional physical therapy program 3 sessions / week , for 6 weeks totally. It consists of stretching exercise, flexor tendon glide and splinting. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Active range of motion (ROM) assessment of metacarpophalangeal joint (MCP):
Time Frame: 6 weeks
|
|
6 weeks
|
|
Active range of motion (ROM) assessment of proximal interphalangeal joint (PIP):
Time Frame: 6 weeks
|
|
6 weeks
|
|
Pain intensity measurement
Time Frame: 6 weeks
|
The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain From 0 to 10 , (0 )means no pain and up to (10) means intolerable pain |
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Southampton Dupuytren's Scoring Scale
Time Frame: 6 weeks
|
The Southampton Dupuytren's Scoring Scheme (SDSS) is a 5-item, 20-point patient-reported outcome measure (PROM) developed in 2014 to assess functional disability from Dupuytren's disease.
It measures impairment across personal, domestic, work, and hobby activities, with scores from 0 (no problem) to 20 (worst), offering high sensitivity to change.
|
6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Amir Zaki, PHD, Cairo University
- Study Chair: Hussein Mogahed, Professor, Cairo University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/006253
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Palmar Fibromatosis
-
Cairo UniversityNot yet recruiting
-
Shandong Provincial HospitalRecruitingAggressive Fibromatosis of Abdominal Wall (Disorder)China
-
European Organisation for Research and Treatment...CompletedDesmoid TumorFrance, Switzerland, Belgium, United Kingdom, Poland, Netherlands, Germany
-
National Cancer Institute (NCI)CompletedDesmoid FibromatosisUnited States, Canada
-
Rabin Medical CenterCompletedDesmoid Fibromatosis | Desmoid | Desmoid Fibromatosis of Skin | Desmoid Neoplasm of Chest Wall | Desmoid Tumor Caused by Somatic Mutation | Aggressive Fibromatoses | Fibromatosis DesmoidIsrael
-
Fondazione IRCCS Istituto Nazionale dei Tumori,...Associazione Italiana per la Ricerca sul CancroUnknownDesmoid Type-fibromatosisItaly
-
Children's Oncology GroupNational Cancer Institute (NCI); SpringWorks Therapeutics, Inc.Active, not recruitingDesmoid Fibromatosis | Recurrent Desmoid Fibromatosis | Unresectable Desmoid FibromatosisUnited States, Canada, Puerto Rico, Australia, New Zealand
-
Erasmus Medical CenterRadboud University Medical Center; Royal Marsden NHS Foundation Trust; The Netherlands...CompletedDesmoid Tumor | Desmoid-type FibromatosisUnited Kingdom, Netherlands
-
MedPacto, Inc.Withdrawn
-
Yonsei UniversityCompletedFibromatosisKorea, Republic of
Clinical Trials on Transfer Energy Capacitive and Resistive (TECAR) therapy
-
Cairo UniversityNot yet recruitingSupraspinatus TendinitisEgypt
-
Cairo UniversityNot yet recruiting
-
University of the Basque Country (UPV/EHU)Completed
-
Umm Al-Qura UniversityDeanship of scientific research at Umm Al-Qura universityNot yet recruiting
-
Medical University of SilesiaCompletedMyofascial Trigger Point Pain | Myofascial Pain Syndrome of Neck | Myofascial Trigger Point SyndromePoland
-
Maimónides Biomedical Research Institute of CórdobaRecruitingHealthy Adult | Muscle FatigueSpain
-
Cairo UniversityCompletedDiabetic Neuropathy, PainfulEgypt
-
Şebnem Nur AlkanCompletedExercise Training | Lumbal Disc Herniation | Capacitive and Resistive Electric Transfer TherapyTurkey
-
Beijing Sport UniversityCompletedChronic Ankle Instability | Capacitive and Resistive Electric Transfer TherapyChina
-
Istanbul UniversityCompletedMyofascial Pain Syndrome of NeckTurkey