NCT06331793

Pulsed Electromagnetic Fields for Analgesia Post Mastectomy

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: European Institute of Oncology · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Female Breast Cancer
• Post Operative Pain

Interventions

Type	Name	Description
DEVICE	Active AlgoCare	Device that emits Pulsed Electromagnetic Fields
DEVICE	Non-active AlgoCare	Device that doesn't emit Pulsed Electromagnetic Fields

Timeline

• Start date: 2023-05-09
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2024-03-26
• Last updated: 2024-03-26

Locations

1 site across 1 country: Italy