Pulsed Electromagnetic Fields for Analgesia Post Mastectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-09

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Female Breast Cancer Post Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomization 1:1

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Double blind

Study Groups

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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.

Group Type EXPERIMENTAL

Active AlgoCare

Intervention Type DEVICE

Device that emits Pulsed Electromagnetic Fields

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.

Group Type PLACEBO_COMPARATOR

Non-active AlgoCare

Intervention Type DEVICE

Device that doesn't emit Pulsed Electromagnetic Fields

Interventions

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Active AlgoCare

Device that emits Pulsed Electromagnetic Fields

Intervention Type DEVICE

Non-active AlgoCare

Device that doesn't emit Pulsed Electromagnetic Fields

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No