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

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

Study Overview

• Status: Recruiting
• Conditions: Post-surgical Hematoma, Hip Replacement , Surgery
• Intervention / Treatment: Other: sessions with ENF (Electro Neuro Feedback).

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: cristina beretta; Phone Number: 0039024878521; Email: cristina.beretta@grupposandonato.it

Study Locations

• Italy
  • Milan, Italy, 20161
    • Recruiting
    • IRCCS Istituto Ortopedico Galeazzi -San Siro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The population is made up of patients who have undergone hip prosthesis surgery with the presence of post-surgical hematoma who are included in the hospital rehabilitation program lasting at least 5 days following this intervention.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
change of post-surgical hematoma measured by ultrasound method with triaxial measurement after 5 treatment sessions with ENF	at the end of Cycle 5 ( every cycle during 5 days)

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Galeazzi
• Investigators: Principal Investigator: cristina beretta, IRCCS istituto ortopedico galeazzi -sede san siro

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2021
• Primary Completion (Actual): November 18, 2021
• Study Completion (Anticipated): July 20, 2023

Study Registration Dates

• First Submitted: November 25, 2021
• First Submitted That Met QC Criteria: January 18, 2022
• First Posted (Actual): January 19, 2022

Study Record Updates

• Last Update Posted (Actual): January 19, 2022
• Last Update Submitted That Met QC Criteria: January 18, 2022
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Hematoma
• Other Study ID Numbers: ENF PTA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No