G90.5 G90.6 G90.7
Conditions
Interventions
Group 1: PEMF Treatment
Group 2: Placebo treatment (device application without effect)
Sponsors
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: CRPS of the upper and/or lower extremity reliably diagnosed according to Budapest criteria (differential diagnoses are excluded)
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CRPS severity score (CSS) relative to baseline comparing verum and sham stimulation after 84 days of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Pain intensity compared verum/sham stimulation relative to baseline after 84 days measured with NRS 0-10 - Motor impairment compared verum/sham stimulation relative to baseline after 84 days, measured with the QuickDash for the upper extremity and Walking Steps for the lower extremity - Emotional well-being compared verum/sham stimulation relative to baseline after 84 days, measured with the Depression Anxiety Stress Scales (DASS) - Sleep compared to verum/sham stimulation relative to baseline after 84 days, measured with the PROMIS-SD (PROMIS Sleep Disturbance) - Impairment due to pain compared to verum/sham stimulation relative to baseline after 84 days, measured with the BPI (Brief Pain Inventory) - Quality of life compared to verum/sham stimulation relative to baseline after 84 days, measured with EQ4 and module L, health-related quality of life, of the German Pain Questionnaire - Somatosensory profile in quantitative sensory testing in comparison verum/sham stimulation relative to baseline after 84 days - Reduction in pain and impairment due to CRPS compared to verum/sham stimulation relative to baseline, measured with the PGIC (Patients Global Impression of Change). Comparison of verum/sham stimulation relative to baseline after 28 days and 84 days of treatment with Oska Pulse: Reduction in pain and impairment due to CRPS compared verum/sham stimulation relative to baseline, as measured by the PGIC (Patients Global Impression of Change). | — |
Countries
Germany
Contacts
Public ContactJanne Gierthmühlen
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Outcome results
None listed