Pulsed Electromagnetic Fields for Analgesia Post Mastectomy (Algocare)

European Institute of Oncology

Status: Enrolling

Conditions: Female Breast Cancer; Post Operative Pain

Treatments: Device: Active AlgoCare; Device: Non-active AlgoCare

Study type: Interventional

Funder types: Other

Identifiers

NCT06331793

IEO 1849

Details and patient eligibility

About

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.

Full description

The treatment of postoperative pain is a priority issue for both the doctor and the patient. Obtaining adequate analgesia in the first postoperative days, in fact, is essential for the patient's comfort, but also to promote and accelerate functional recovery and prevent chronic pain, which in the case of breast surgery has a high incidence (20-60 %).

The use of pulsed electromagnetic fields (PEMF) for the treatment of pain and inflammation has been widely studied and validated.

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. This is a field of application in which this technique analgesic has never been tested, but in which it could prove valid within a multimodal analgesia protocol, as the pain caused by this type of intervention is predominantly parietal and resulting from tissue trauma caused by the surgical wound. AlgoCare is a non-invasive and non-pharmacological device, developed specifically for treatment of post-operative inflammation and pain, CE certified and registered with the Ministry of Health. It emits a pulsed radio frequency electromagnetic field at 27.1 MHz, a frequency already studied and approved for medical use.

Enrollment: 160 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 2 patient groups, including a placebo group

Active AlgoCare

Experimental group

Description:

An active AlgoCare device (that emits a pulsed radio frequency electromagnetic field at 27.1 MHz) will be placed over the surgical dressing using a plaster or bandage for six days.

Treatment:

Device: Active AlgoCare

Non-active AlgoCare

Placebo Comparator group

Description:

A non-active AlgoCare device (that doesn't emit pulsed radio frequency electromagnetic field) will be placed over the surgical dressing using a plaster or bandage for six days.

Treatment:

Device: Non-active AlgoCare