Pulsed Electromagnetic Fields (PEMFS) in Complex Regional Pain Syndrome Type i (CRPS-I) of the Foot (PeCFoA)

Launched by AZIENDA OSPEDALIERO-UNIVERSITARIA CONSORZIALE POLICLINICO DI BARI · Jun 19, 2023

Keywords

ClinConnect Summary

This clinical trial, called PeCFoA, is studying a treatment called I-ONE® therapy, which uses pulsed electromagnetic fields (PEMFs) to help patients with Complex Regional Pain Syndrome Type I (CRPS-I) in their foot or ankle. The goal is to see if combining this therapy with standard rehabilitation can improve pain relief and recovery for patients suffering from this condition. CRPS-I is a chronic pain syndrome that can develop after an injury, and the trial is looking for participants who have experienced this type of pain for up to three years.

To be eligible for the trial, participants need to have a diagnosis of CRPS-I that specifically affects their foot or ankle and report a pain level of at least 5 out of 10 on a pain scale. This trial is open to people aged 65 to 74 of any gender. Participants will receive I-ONE® therapy along with standard rehabilitation and will be monitored throughout the study to evaluate how well the treatment works. It's important to note that individuals with certain neurological issues or specific medical conditions, like having a cardiac pacemaker, cannot participate. Overall, this trial aims to find new ways to manage and reduce pain for those suffering from CRPS-I.

Gender

ALL

Eligibility 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