Pulsed Electromagnetic Fields for Analgesia Post Mastectomy

Post Operative Pain Clinical Trial

— Algocare  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06331793
• Other study ID #: IEO 1849
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Female Breast Cancer
• Pain, Postoperative
• Post Operative Pain

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