Diamagnetic Therapy in Pain and Inflammation (DiaPI)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain; Inflammation

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

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Luca Gallelli, MD; Phone Number: 0961712322; Email: gallelli@unicz.it

Study Locations

• Italy
  • Catanzaro, Italy, 88100
    • Recruiting
    • Luca Gallelli
    • Contact: Luca Gallelli, MD; Email: gallelli@unicz.it
  • Italia
    • Catanzaro, Italia, Italy, 88100
      • Recruiting
      • AOU Dulbecco Catanzaro
      • Contact: Luca Gallelli, MD; Phone Number: +390961712537; Email: gallelli@unicz.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. presence of active malignancy of any type or history of malignancy
2. Local or systemic infection.
3. 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.
4. Any case not described in the inclusion criteria. Patients with contraindication to magnetic resonance imaging

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Catanzaro

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2025
• Primary Completion (Estimated): July 19, 2025
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: February 19, 2025
• First Submitted That Met QC Criteria: February 19, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 19, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: PEMFs

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No