Diamagnetic Therapy in Pain and Inflammation

NCT06844552 | Recruiting

• 1 other identifier: PEMFs
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Pain; Inflammation

Outcome Measures

Primary Outcomes (1)

• pain change

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

  12 months

Secondary Outcomes (1)

• mood anxiety : zung scale

  12 months

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Catanzaro: lead

Study Sites (2)

AOU Dulbecco Catanzaro

Catanzaro, Italia, 88100, Italy

RECRUITING

Luca Gallelli

Catanzaro, 88100, Italy

RECRUITING

MeSH Terms

Conditions

Pain; Inflammation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Central Study Contacts

Luca Gallelli, MD

CONTACT

0961712322; gallelli@unicz.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: February 25, 2025
• Study Start: February 19, 2025
• Primary Completion: July 19, 2025
• Study Completion (Estimated): February 28, 2027
• Last Updated: February 25, 2025

Record last verified: 2025-02

Locations

IT (2)