Pulsed Electromagnetic Fields for Analgesia Post Mastectomy (Algocare)

Use of a Wearable Device Which Generates an Electromagnetic Pulsed Field for Postoperative Analgesia of Mastectomies

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.

Study Overview

• Status: Recruiting
• Conditions: Post Operative Pain; Female Breast Cancer
• Intervention / Treatment: Device: Active AlgoCare; Device: Non-active AlgoCare

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.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniele Sances, MD; Phone Number: +390257489618; Email: daniele.sances@ieo.it

Study Locations

• Italy
  • Milan, Italy, 20141
    • Recruiting
    • European Institute of Oncology
    • Contact: Daniele Sances, MD; Phone Number: +390257489618; Email: daniele.sances@ieo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Active AlgoCare; Device that emits Pulsed Electromagnetic Fields
Placebo Comparator: 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.	Device: Non-active AlgoCare; Device that doesn't emit Pulsed Electromagnetic Fields

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for analgesic drugs	Compare analgesic drugs use between the two arms	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	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	3 months
Need for other drugs	Compare use of drugs (other than analgesic ones) between the two arms	3 months
Wound healing timing	Compare days needed to complete wound healing between the two arms	3 months

Collaborators and Investigators

• Sponsor: European Institute of Oncology
• Investigators: Principal Investigator: Daniele Sances, MD, European Institute of Oncology

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 18, 2024
• First Submitted That Met QC Criteria: March 22, 2024
• First Posted (Actual): March 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Post Operative Pain; Unilateral mastectomy with reconstruction
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: IEO 1849

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No