Use of a Wearable Device Which Generates an Electromagnetic Pulsed Field for Postoperative Analgesia of Mastectomies
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Female Breast Cancer
- Sponsor
- European Institute of Oncology
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Pain intensity
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Pain intensity
Time Frame: 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 Outcomes
- Patient reported pain characteristics(3 months)
- Need for other drugs(3 months)
- Number of participants with other symptoms(3 months)
- Need for analgesic drugs(3 months)
- Wound healing timing(3 months)