Pulsed Electromagnetic Fields for Analgesia Post Mastectomy
- Conditions
- Post Operative PainFemale Breast Cancer
- Interventions
- Device: Non-active AlgoCareDevice: Active AlgoCare
- Registration Number
- NCT06331793
- Lead Sponsor
- European Institute of Oncology
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 160
- Breast cancer patients undergoing unilateral mastectomy with reconstruction and without axillary dissection
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Non-active AlgoCare Non-active AlgoCare 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. Active AlgoCare Active AlgoCare 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.
- Primary Outcome Measures
Name Time Method Pain intensity 72 hours Difference in mean NRS score between the two arms, at 24 hours and 72 hours after surgery (minimum value: 0, maximum value: 10 - higher scores mean a worse outcome)
- Secondary Outcome Measures
Name Time Method Patient reported pain characteristics 3 months Compare characteristics of pain between the two arms by collection of a questionnaire that describes kind of pain experienced by patient
Need for other drugs 3 months Compare use of drugs (other than analgesic ones) between the two arms
Number of participants with other symptoms 3 months Compare presence of other symptoms between the two arms by collection of a questionnarie in which patient reports occurence of nausea, vomiting or other symptoms
Need for analgesic drugs 3 months Compare analgesic drugs use between the two arms
Wound healing timing 3 months Compare days needed to complete wound healing between the two arms
Trial Locations
- Locations (1)
European Institute of Oncology
🇮🇹Milan, Italy