Clinical effects of treatment of complex regional pain syndrome (CRPS) with pulsed electromagnetic fields (PEMF): a double-blind randomized controlled pilot study

Phase 4

Recruiting

• Conditions: G90.5; G90.6; Complex regional pain syndrome type I; G90.7; Complex regional pain syndrome type II; Complex regional pain syndrome, other and unspecified type

• Registration Number: DRKS00033005
• Lead Sponsor: niversitätsklinikum Schleswig-Holstein, Campus Kiel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-09
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

CRPS of the upper and/or lower extremity reliably diagnosed according to Budapest criteria (differential diagnoses are excluded)

Exclusion Criteria

Change in therapy in the last 3 weeks before inclusion in the study or cortisone therapy within the last four weeks before inclusion
- Patients who are not capable of giving informed consent themselves
- Patients who are physically or mentally incapable of using the device independently
- Patients with cognitive deficits or limited knowledge of the German language, which may lead to difficulties in data collection
- Patients with pacemakers, defibrillators or other active implants
- Patients with magnetic implants (non-MRI compatible implants)
- Patients receiving corticosteroid injections
- Patients with severe infections, polyneuropathy or other neurological diseases that can affect sensory or motor function and that cannot be differentiated from CRPS by the patient
- Patients who are pregnant or breastfeeding
- Patients with tumor diseases
- Patients with a tendency to bleed

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CRPS severity score (CSS) relative to baseline comparing verum and sham stimulation after 84 days of treatment.