Evaluation of the Efficacy of Electromagnetic Therapy on Postoperative Surgical Pain After Uni- and Bilateral Inguinal Hernia Repair.

Not Applicable

Completed

• Conditions: Inguinal Hernias
• Interventions: Device: Magnetic field therapy device; Device: Non magnetic field therapy device.

• Registration Number: NCT01842204
• Lead Sponsor: University Hospital, Ghent

Brief Summary

A monocentric interventional randomized placebo controlled trial evaluating the efficacy of the post surgical and wound care recovery kit.

It's a small device that consists of a thin metal ring that is placed on the skin surface, non-invasively. It's connected with a small battery. When the plastic tag is removed and the button is pushed the device is activated. Within the ring a Pulsed Electromagnetic Field is created. It influences the receptor-ligand binding at the cell surface and might improve wound healing by diminishing wound edema and inflammation. It possibly helps reducing the inflammatory reaction induced by surgery.

Patients will be treated for uni or bilateral inguinal hernias and at the end of surgery, at the time of bandage, a kit will be applied at the level of the incision. One group will at random receive a working device, the other half will have a kit without active electromagnetic field.

Postoperative analgesic consumption will be measured in a diary and pain and quality of life will be measured using Visual Analogue Scale and EuraHS-Quality Of Life questionnaires.

The aim of this study is to evaluate whether the placement of the device reduces the acute postoperative pain and whether it reduces the incidence of chronic groin pain.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-04-24
• Study First Submitted QC: 2013-04-24
• Study First Posted: 2013-04-29
• Study Start: 2013-05
• Primary Completion: 2015-12
• Study Completion: 2023-08
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Written informed consent from the patient
• Primary, unilateral and bilateral groin hernias

Exclusion Criteria

• No written informed consent
• Recurrent hernias
• 'Incarcerated' hernias
• pregnant women: reaction of a Pulsed Electromagnetic Field on the foetus is unknown
• Patients with pacemaker or Internal defibrillator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
active kit	Magnetic field therapy device	Patient receives an active kit with pulsed electromagnetic field over wound surface area.
non-active kit	Non magnetic field therapy device.	Patient receives a non-active kit.

Primary Outcome Measures

Name	Time	Method
Postoperative analgesic requirement after 1 week.	1 week after the surgery.	Evaluation through Questionnaires, VAS, euraHS QOL, diary.

Secondary Outcome Measures

Name	Time	Method
chronic pain at 3 months post-surgery.	3 months post surgery.	Clinical evaluation and VAS.

Trial Locations

Locations (1)

Ghent University Hospital; 🇧🇪 Ghent, Belgium