Clinical trial · Interventional
Pulsed Electromagnetic Fields for Analgesia Post Mastectomy
Use of a Wearable Device Which Generates an Electromagnetic Pulsed Field for Postoperative Analgesia of Mastectomies
NCT06331793CI-TRIAL-00075418AlgocareunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Female Breast Cancer | — | UNRESOLVED | — |
| Post Operative Pain | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Active AlgoCare | Device | — | UNRESOLVED |
| Non-active AlgoCare | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Active AlgoCare
- description
- 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.
- interventionNames
- Device: Active AlgoCare
- type
- PLACEBO_COMPARATOR
- label
- Non-active AlgoCare
- description
- 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.
- interventionNames
- Device: Non-active AlgoCare
Primary outcomes (1)
- measure
- Pain intensity
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.