Diamagnetic Therapy in Pain and Inflammation

Официальное название

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

Обзор

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.

Подробное описание

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

Первичные конечные точки

• pain change [Срок оценки: 12 months]

Вторичные конечные точки (1)

• mood anxiety : zung scale [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Patients of both sexes between 18 and 75 years old
• Patients with pain and or inflammation (e.g. osteoarthritis, trauma, prostatitis)
• Patients with VAS (Visual Analogue Scale) intensities higher than 5/10 who did not respond to systemic medication therapy.
• Patients who can comprehend the study's objectives and adhere to the clinical instructions, return for follow-up, and complete the evaluation questionnaires.
• Patients able to provide their written informed consent to participate to the study and to use their data anonymously for scientific purposes

Критерии исключения

• presence of active malignancy of any type or history of malignancy
• Local or systemic infection.
• Uncooperative patient or suffering from neurological disorders, therefore unable to follow the clinical instructions or unable to provide informed consent for participation in the study or who have not provided written consent.
• Any case not described in the inclusion criteria. Patients with contraindication to magnetic resonance imaging

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 2 центра

• AOU Dulbecco Catanzaro — Catanzaro
• Luca Gallelli — Catanzaro

Идентификаторы

NCT: NCT06844552 · PEMFs

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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