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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
160
Device that emits Pulsed Electromagnetic Fields
Device that doesn't emit Pulsed Electromagnetic Fields
European Institute of Oncology
Milan, Italy
RECRUITINGPain intensity
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)
Time frame: 72 hours
Need for analgesic drugs
Compare analgesic drugs use between the two arms
Time frame: 3 months
Patient reported pain characteristics
Compare characteristics of pain between the two arms by collection of a questionnaire that describes kind of pain experienced by patient
Time frame: 3 months
Number of participants with other symptoms
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
Time frame: 3 months
Need for other drugs
Compare use of drugs (other than analgesic ones) between the two arms
Time frame: 3 months
Wound healing timing
Compare days needed to complete wound healing between the two arms
Time frame: 3 months
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