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Not yet recruiting NCT07443371

Effect of Transfer Energy Capacitive and Resistive Therapy on Palmar Fibromatosis

No phase Interventional Palmar Fibromatosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transfer Energy Capacitive and Resistive (TECAR) therapy, Traditional therapy.
Who it may be relevant to
Registry conditions: Palmar Fibromatosis. Basic parameters: 40 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The objective of the present study is 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).

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).

Interventions

  • Device Transfer Energy Capacitive and Resistive (TECAR) therapy
    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 capac
  • Other Traditional therapy
    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.

Primary outcome measures

  • Active range of motion (ROM) assessment of metacarpophalangeal joint (MCP): [Time frame: 6 weeks]
  • Active range of motion (ROM) assessment of proximal interphalangeal joint (PIP): [Time frame: 6 weeks]
  • Pain intensity measurement [Time frame: 6 weeks]
Secondary outcome measures (1)
  • The Southampton Dupuytren's Scoring Scale [Time frame: 6 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Peter Milad Haroun — Cairo

Identifiers

NCT: NCT07443371 · P.T.REC/012/006253

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗