Using pulsed electromagnetic fields to treat foot pain from complex regional pain syndrome
PEMFS in Patients With CRPS-I of the Foot and Ankle: a Randomized Controlled Trial
NA · Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari · NCT05922618
This study tests if a new therapy using pulsed electromagnetic fields can help people with foot pain from Complex Regional Pain Syndrome feel better and recover faster when combined with regular rehabilitation.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari (other) |
| Locations | 1 site (Bari) |
| Trial ID | NCT05922618 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of I-ONE® therapy combined with standard rehabilitation for patients suffering from Complex Regional Pain Syndrome Type I (CRPS-I) affecting the foot or ankle. It is a spontaneous, prospective, randomized study that includes a control group to assess functional and clinical improvements. Participants will receive local biophysical stimulation alongside their rehabilitation treatment to optimize recovery outcomes. The study aims to determine if this combined approach leads to better pain management and functional recovery.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with type I CRPS affecting the foot or ankle, experiencing moderate to severe pain.
Not a fit: Patients with neurological pathologies or those with type II CRPS will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve pain management and functional recovery for patients with CRPS-I of the foot or ankle.
How similar studies have performed: Other studies have shown promise in using pulsed electromagnetic fields for pain management, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of type I CRPS according to the Budapest criteria (table 1) * Type I CRPS involving the ankle or foot * Onset of CRPS type I up to a maximum of 3 years after the symptomatic event * Pain on visual analog scale (VAS) scale quantified as intensity at least ≥ 5 at recruitment * Pharmacological treatment with first infusion cycle of neridronate Exclusion Criteria: * Neurological pathologies (stroke, degenerative, traumatic pathologies) * Local neurological impairment (type II CRPS), confirmed by a conduction test or similar * Cardiac pacemaker, treatment site malignancy
Where this trial is running
Bari
- Angela Notarnicola — Bari, Italy (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pain, Joint, Complex Regional Pain Syndromes, Ankle Disease, Foot Diseases, foot, ankle