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

Inclusion Criteria1

  • Breast cancer patients undergoing unilateral mastectomy with reconstruction and without axillary dissection

Exclusion Criteria3

  • Patients with PaceMakers (PMs), Implantable Cardioverter Defibrillators (ICDs), neurostimulators or other active medical devices or metal implants near the application area
  • Pregnancy
  • Amyloidosis, sarcoidosis, scleroderma, infectious arthritis, Paget's disease or joint tumors

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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