An interventional study of dorsal root ganglion stimulation cessation in CRPS (Complex Regional Pain Syndrome) Type I, sponsored by AZ Delta. Completed at 1 site in Belgium. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-04-24.
Sponsored by AZ Delta · Not applicable, Interventional, and Diagnostic
Exclusion Criteria:
Device: dorsal root ganglion stimulation cessation
Treatment of DRGS will be stopped at home and physiological parameters will be monitored with bio wearables at home. physiological parameters will be monitored during a baseline period, before stopping DRGS. While DRGS is stopped. And during the period while the DRGS is turned back on.
Heart Rate
Heart Rate (beats per minute), measured using the Corsano Biosensor 287-2 wearable device (CE-MDR certified)
Time frame: 1 week
Heart Rate Variability
Heart Rate Variability (milliseconds), measured using the Corsano Biosensor 287-2 wearable device (CE-MDR certified)
Time frame: 1 week
Respiratory Rate
Respiratory Rate (breaths per minute), measured using the Corsano Biosensor 287-2 wearable device (CE-MDR certified)
Time frame: 1 week
Blood Pressure
Non-invasive Cuffless Blood Pressure: systolic, mean and diastolic (mmHg), measured using the Corsano Biosensor 287-2 wearable device (CE-MDR certified)
Time frame: 1 week
Body Temperature
Core Body Temperature (°C), measured using the Corsano Biosensor 287-2 wearable device (CE-MDR certified)
Time frame: 1 week
Oxygen Saturation
Oxygen Saturation (SpO2, %), measured using the Corsano Biosensor 287-2 wearable device (CE-MDR certified)
Time frame: 1 week
Sleep Quality
Sleep quality is measured using the MotionWatch 8 actigraphy device (FDA-cleared, CE-marked). For each night of sleep, the bed times and get-up times are entered (either manually, graphically or automatically) and the software automatically determines the sleep start and end times. The analysis then utilises the night-time movement data (e.g. immobile mins and mobile mins) to determine the quality of sleep and provides a list of key sleep parameters.
Time frame: 1 week
Physical Activity
Physical Activity (activity counts per time frame) is measured using the MotionWatch 8 actigraphy device (FDA-cleared, CE-marked).
Time frame: 1 week
Pain intensity
Pain intensity (patient-reported) will be assessed using the Numeric Rating Scale (NRS; 0 = no pain, 10 = worst possible pain), recorded three times daily.
Time frame: 1 week
Sleep quality
Sleep quality (patient-reported) will be evaluated with a five-point Likert scale (1 = strongly disagree to 5 = strongly agree) based on specific sleep-related statements.
Time frame: 1 week
Patient Global Impression of Improvement
Patient Global Impression of Improvement (PGI-I) will be used to assess overall patient-perceived change, using a seven-point Likert scale (1 = very much improved, 7 = very much worse).
Time frame: 1 week
Pain condition-related medication usage
Medication intake will be recorded daily by the participant as a count of analgesic medication dosages taken.
Time frame: 1 week
Plan to share: Yes — Plan Description: De-identified individual participant data (IPD), including physiological parameters (heart rate variability, respiratory rate, blood pressure, oxygen saturation, skin temperature) and secondary outcomes (pain intensity scores, sleep quality assessments, medication intake, and patient global impression of improvement) will be shared with the Research Stimulus Group at Vrije Universiteit Brussel. The data will be used for real-time monitoring, statistical analysis, and preparation of scientific manuscripts related to this study. Access Criteria: Access to the IPD will be restricted to members of the Research Stimulus Group who are directly involved in the analysis and interpretation of the EPIC-DRG study data. Data handling will fully comply with GDPR regulations and institutional data protection policies. No public sharing of raw data is planned. Time Frame: Data will be transmitted continuously throughout the study period to enable interim analysis and monitoring, w
Supporting information: Study protocol, Sap, Csr, Analytic code
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Complex Regional Pain Syndromes→
AZ Delta