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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06331793
Other study ID # IEO 1849
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 9, 2023
Est. completion date December 31, 2024

Study information

Verified date March 2024
Source European Institute of Oncology
Contact Daniele Sances, MD
Phone +390257489618
Email daniele.sances@ieo.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Recruiting
Enrollment 160
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Device:
Active AlgoCare
Device that emits Pulsed Electromagnetic Fields
Non-active AlgoCare
Device that doesn't emit Pulsed Electromagnetic Fields

Locations

Country Name City State
Italy European Institute of Oncology Milan

Sponsors (1)

Lead Sponsor Collaborator
European Institute of Oncology

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain 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) 72 hours
Secondary Need for analgesic drugs Compare analgesic drugs use between the two arms 3 months
Secondary 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 3 months
Secondary 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 3 months
Secondary Need for other drugs Compare use of drugs (other than analgesic ones) between the two arms 3 months
Secondary Wound healing timing Compare days needed to complete wound healing between the two arms 3 months
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