Pulsed Electromagnetic Fields (PEMFS) in Complex Regional Pain Syndrome Type i (CRPS-I) of the Fo… (NCT05922618) | Clinical Trial Compass
CompletedNot Applicable
Pulsed Electromagnetic Fields (PEMFS) in Complex Regional Pain Syndrome Type i (CRPS-I) of the Foot (PeCFoA)
Italy28 participantsStarted 2023-08-01
Plain-language summary
The investigators hypothesize that the association of I-ONE® therapy with standard rehabilitation treatment can optimize the clinical and functional recovery of patients with pulsed electromagnetic fields (PEMFs) (I-ONE® therapy) of the foot or ankle.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with allodynia
Timeframe: Change from baseline at 3 months
2
Number of participants with allodynia
Timeframe: Change from baseline at 6 months
3
Number of participants with allodynia
Timeframe: Change from baseline at 12 months
4
Number of participants with hyperalgesia
Timeframe: Change from baseline at 3 months
5
Number of participants with hyperalgesia
Timeframe: Change from baseline at 12 months
6
Rate of edema
Timeframe: Change from baseline at 3 months
7
Rate of edema
Timeframe: Change from baseline at 6 months
8
Trial details
NCT IDNCT05922618
SponsorAzienda Ospedaliero-Universitaria Consorziale Policlinico di Bari