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This is a prospective longitudinal single-center clinical study on pain patients treated with Low Frequency High Intensity- Pulsed Magnetic Fields (LF-HI-PEMF; diamagnetic therapy) . Patients were enrolled at baseline (T0) and then were monitored at 30 days (T1), 60 days (T2), 90 days (T3). and 360 days (T4). The first efficacy end-point was the statistically significant difference (P<0.05) in VAS scale between T2-T4 and T0.
This is a prospective longitudinal single-center clinical study on pain patients treated with Low Frequency High Intensity- Pulsed Magnetic Fields (LF-HI-PEMF; diamagnetic therapy) at the Pain Medicine Room of the Clinical Pharmacology and Pharmacovigilance Operative Unit of the "Renato Dulbecco" University Hospital of Catanzaro. Patients were enrolled at baseline (T0) and then were monitored during the follow-up (T1; 1 months; T2; 2 months; T3; 3 months; T4: 1 year). At the beginning of the study, all enrolled patients signed the informed consent before admission to the study. After the enrollment (T0) and during the follow ups (T1-T4), clinical and laboratory data were collected directly by the medical staff involved in the study and Zung SAS, Zung SDS and SF-36 questionnaires were administered. The dedicated database evaluated and recorded any systemic or local side effects. The Low Frequency High Intensity- Pulsed Magnetic Fields - LF-HI-PEMF was locally used. In patients that experienced low efficacy, a topical treatment was added. A group of patients that refused PEMFs or without indication for PEMFs, a topical treatment was used. Before the admission to this study, all the enrolled patients received systemic treatments without clinical benefit. The first efficacy end-point was the statistically significant difference (P<0.05) in VAS scale between T1 and T0, T2 and T1 and between T3 and T2-T0 and and T4 vs T3,T2,T1,T0
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated | Low Frequency High Intensity- Pulsed Magnetic Fields - LF-HI-PEMF | ||
| Treated + topical treatment | Low Frequency High Intensity- Pulsed Magnetic Fields - LF-HI-PEMF plus topical treatment + topical treatment | ||
| topical treatment | topical treatment |
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| Measure | Description | Time Frame |
|---|---|---|
| pain change | NRS values: with a 0-10 scale, where 0 is no pain and 10 is extreme pain | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| mood anxiety : zung scale | 20-items: score 0 - 44: no anxiety; 45 - 59 moderate anxiety; 60 - 80 severe anxiety | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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After the enrollment (T0) and during the follow ups (T1-T3), clinical and laboratory data were collected directly by the medical staff involved in the study and Zung SAS, Zung SDS questionnaires were administered. The dedicated database evaluated and recorded any systemic or local side effects. At the beginning of the study (T0) low Frequency High Intensity- Pulsed Magnetic Fields - LF-HI-PEMF was topically used in agreement with leaflet of the instrument with or without topical treatment. A group of patients received a treatment with topical compounds in agreement with the leaflet. Before the admission to this study, all the enrolled patients received systemic treatments without clinical benefit
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luca Gallelli, MD | Contact | 0961712322 | gallelli@unicz.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOU Dulbecco Catanzaro | Recruiting | Catanzaro | Italia | 88100 | Italy |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
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| Luca Gallelli | Recruiting | Catanzaro | 88100 | Italy |
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