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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active AlgoCare | Experimental | 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. |
|
| Non-active AlgoCare | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active AlgoCare | Device | Device that emits Pulsed Electromagnetic Fields |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniele Sances, MD | Contact | +390257489618 | daniele.sances@ieo.it |
| Name | Affiliation | Role |
|---|---|---|
| Daniele Sances, MD | European Institute of Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| European Institute of Oncology | Recruiting | Milan | 20141 | Italy |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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Randomization 1:1
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Double blind
| Non-active AlgoCare |
| Device |
Device that doesn't emit Pulsed Electromagnetic Fields |
|
| 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 |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |