RecruitingNot ApplicableNCT06331793

Pulsed Electromagnetic Fields for Analgesia Post Mastectomy

Use of a Wearable Device Which Generates an Electromagnetic Pulsed Field for Postoperative Analgesia of Mastectomies


Sponsor

European Institute of Oncology

Enrollment

160 participants

Start Date

May 9, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Study aim is to test AlgoCare, a device that uses the technology PEMF (Pulsed ElectroMagnetic Fields) for the treatment of postoperative pain in oncological breast surgery, in order to demonstrate that the use of Algocare in the postoperative period allows for a reduction in pain intensity in terms of Numerical Rating Scale (NRS) score and use of analgesic drugs.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether pulsed electromagnetic field (PEMF) therapy — a non-invasive device that delivers low-level electromagnetic pulses to tissue — can reduce pain after mastectomy (surgical removal of a breast) with reconstruction. Post-mastectomy pain is common and can be difficult to manage; PEMF therapy has shown promise in reducing inflammation and pain in other surgical contexts. **You may be eligible if:** - You have breast cancer and are undergoing a single-sided (unilateral) mastectomy with reconstruction - You are not having axillary lymph node removal as part of your surgery **You may NOT be eligible if:** - You have a pacemaker, implantable defibrillator, nerve stimulator, or other active electronic device near the treatment area - You are pregnant - You have amyloidosis, sarcoidosis, scleroderma, infectious arthritis, Paget's disease, or tumors in the joints Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEActive AlgoCare

Device that emits Pulsed Electromagnetic Fields

DEVICENon-active AlgoCare

Device that doesn't emit Pulsed Electromagnetic Fields


Locations(1)

European Institute of Oncology

Milan, Italy

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NCT06331793


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