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Trial Title:
Pulsed Electromagnetic Fields for Analgesia Post Mastectomy
NCT ID:
NCT06331793
Condition:
Female Breast Cancer
Post Operative Pain
Conditions: Official terms:
Pain, Postoperative
Conditions: Keywords:
Unilateral mastectomy with reconstruction
Post Operative Pain
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Randomization 1:1
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Masking description:
Double blind
Intervention:
Intervention type:
Device
Intervention name:
Active AlgoCare
Description:
Device that emits Pulsed Electromagnetic Fields
Arm group label:
Active AlgoCare
Intervention type:
Device
Intervention name:
Non-active AlgoCare
Description:
Device that doesn't emit Pulsed Electromagnetic Fields
Arm group label:
Non-active AlgoCare
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.
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
European Institute of Oncology
Address:
City:
Milan
Zip:
20141
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Daniele Sances, MD
Phone:
+390257489618
Email:
daniele.sances@ieo.it
Start date:
May 9, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
European Institute of Oncology
Agency class:
Other
Source:
European Institute of Oncology
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06331793
