Using Pulsed Electromagnetic Fields to Reduce Pain After Mastectomy
Use of a Wearable Device Which Generates an Electromagnetic Pulsed Field for Postoperative Analgesia of Mastectomies
This study is testing if a device that uses pulsed electromagnetic fields can help reduce pain after surgery for patients who have had a mastectomy with reconstruction.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | European Institute of Oncology Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT06331793 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of the AlgoCare device, which utilizes Pulsed Electromagnetic Fields (PEMF), in alleviating postoperative pain for patients undergoing unilateral mastectomy with reconstruction. The primary focus is to assess pain intensity through the Numerical Rating Scale (NRS) and the reduction in analgesic drug usage. The study addresses a critical need for effective pain management in the early postoperative period, which is essential for patient comfort and recovery. AlgoCare is a non-invasive, CE certified device designed specifically for treating post-operative pain and inflammation.
Who should consider this trial
Good fit: Ideal candidates are female breast cancer patients undergoing unilateral mastectomy with reconstruction who do not have any contraindicating medical devices.
Not a fit: Patients with pacemakers, implantable cardioverter defibrillators, or other active medical devices near the treatment area will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve pain management for breast cancer patients after surgery, enhancing their recovery experience.
How similar studies have performed: While the use of PEMF for pain management has been validated in other contexts, this specific application in postoperative breast surgery is novel and has not been previously tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Milan
- European Institute of Oncology — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Daniele Sances, MD — European Institute of Oncology
- Study coordinator: Daniele Sances, MD
- Email: daniele.sances@ieo.it
- Phone: +390257489618
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.