Clinical trial NCT06331793: Pulsed Electromagnetic Fields for Analgesia Post Mastectomy
Official title: Use of a Wearable Device Which Generates an Electromagnetic Pulsed Field for Postoperative Analgesia of Mastectomies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Female Breast Cancer
Post Operative Pain
Keywords: Unilateral mastectomy with reconstruction
Post Operative Pain
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization 1:1
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain intensity
timeFrame: 72 hours
Secondary outcomes:
measure: Need for analgesic drugs
timeFrame: 3 months
measure: Patient reported pain characteristics
timeFrame: 3 months
measure: Number of participants with other symptoms
timeFrame: 3 months
measure: Need for other drugs
timeFrame: 3 months
measure: Wound healing timing
timeFrame: 3 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: European Institute of Oncology
Study officials:
affiliation: European Institute of Oncology
name: Daniele Sances, MD
role: PRINCIPAL_INVESTIGATOR
References: