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NCT Number: NCT06844552

Diamagnetic Therapy in Pain and Inflammation

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

AOU Dulbecco Catanzaro, Catanzaro, Italia, Italy

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. pain change

    Time frame: 12 months

    NRS values: with a 0-10 scale, where 0 is no pain and 10 is extreme pain

Secondary outcomes

  1. mood anxiety : zung scale

    Time frame: 12 months

    20-items: score 0 - 44: no anxiety; 45 - 59 moderate anxiety; 60 - 80 severe anxiety

Study contacts

Contact information is provided by the study sponsor or research team.

Luca Gallelli, MD

CONTACT

[email protected]

0961712322

Sponsors and collaborators

Lead sponsor

University of Catanzaro

Other

Registry information

Official study title

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

Acronym: DiaPI

Important dates

Study start
2025
Primary completion
2025
Study completion
2027
First posted
Feb 25, 2025
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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