NCT06844552

Diamagnetic Therapy in Pain and Inflammation

Low Frequency High Intensity- Pulsed Magnetic Fields (LF-HI-PEMF) in Pain and Inlfammation

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: University of Catanzaro · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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 * the statistically significant difference (P\<0.05) in functional mobility and walking ability (six minutes walking test) between T2 and T0 and between T3 and T2 * the statistically significant difference (P\<0.05) in mood disorders (Zung SAS and Zung SDS) between T2 and T0 and between T3 and T2

Conditions

• Pain
• Inflammation

Timeline

• Start date: 2025-02-19
• Primary completion: 2025-07-19
• Completion: 2027-02-28
• First posted: 2025-02-25
• Last updated: 2025-02-25

Locations

2 sites across 1 country: Italy