Effects of Treatment With ENF (Electro Neuro Feedback) in the Reduction of Post-surgical Hematoma in Patients Undergoing Hip Replacement: Evaluation With Ultrasound Method

NCT ID: NCT05196321

Last Updated: 2022-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-11

Study Completion Date

2023-07-20

Brief Summary

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The study evaluates patients with clinical evidence of post-surgical hematoma / seroma after hip replacement surgery. These patients will undergo ultrasound evaluation in the 4th (+/- 2) day post surgery, in which triaxial parameters of the hematoma will be measured. This evaluation will then be repeated after 5 treatment sessions with ENF (Electro Neuro Feedback). The patient will then be subjected to evaluation scales that allow to evaluate the subjective improvement of the state of well-being after treatment ENF (Electro Neuro Feedback) generates waveforms that change automatically when the impedance of the skin changes according to a compensation algorithm, i.e. according to Feedback (Feedback). T

Detailed Description

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Conditions

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Post-surgical Hematoma, Hip Replacement , Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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sessions with ENF (Electro Neuro Feedback).

The study evaluates patients with clinical evidence of post-surgical hematoma / seroma after hip replacement surgery. These patients will undergo ultrasound evaluation in the 4th (+/- 2) day post surgery, in which triaxial parameters of the hematoma will be measured. This evaluation will then be repeated after 5 treatment sessions with ENF (Electro Neuro Feedback).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Gender: male and female
* Age: 35-85 years include
* Entry into the hospital rehabilitation program lasting at least 5 days following hip replacement surgery
* Absence in history of neurological or psychiatric disorders.
* Signature of the Informed Consent and consent to collaborate in all the procedures of the study

Exclusion Criteria

* Presence of severe neurological / psychiatric pathologies
* to sign the Informed Consense
* of serious cardiological pathologies that can compromise patient safety
* of Pace Maker or spinal cord stimulators or other subcutaneous electronic instruments
* of active tumors in the treatment area
Minimum Eligible Age

35 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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cristina beretta

Role: PRINCIPAL_INVESTIGATOR

IRCCS istituto ortopedico galeazzi -sede san siro

Locations

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IRCCS Istituto Ortopedico Galeazzi -San Siro

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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cristina beretta

Role: CONTACT

0039024878521

Other Identifiers

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ENF PTA

Identifier Type: -

Identifier Source: org_study_id

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