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| Name | Class |
|---|---|
| Vrije Universiteit Brussel | OTHER |
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evaluation of cessation dorsal root ganglion stimulation in patients with CRPS I. | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dorsal root ganglion stimulation cessation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate | Heart Rate (beats per minute), measured using the Corsano Biosensor 287-2 wearable device (CE-MDR certified) | 1 week |
| Heart Rate Variability | Heart Rate Variability (milliseconds), measured using the Corsano Biosensor 287-2 wearable device (CE-MDR certified) | 1 week |
| Respiratory Rate | Respiratory Rate (breaths per minute), measured using the Corsano Biosensor 287-2 wearable device (CE-MDR certified) | 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) | 1 week |
| Body Temperature | Core Body Temperature (°C), measured using the Corsano Biosensor 287-2 wearable device (CE-MDR certified) | 1 week |
| Oxygen Saturation | Oxygen Saturation (SpO2, %), measured using the Corsano Biosensor 287-2 wearable device (CE-MDR certified) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 week |
| Sleep quality |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Delta | Roeselare | 8800 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37582839 | Result | Patterson DG, Wilson D, Fishman MA, Moore G, Skaribas I, Heros R, Dehghan S, Ross E, Kyani A. Objective wearable measures correlate with self-reported chronic pain levels in people with spinal cord stimulation systems. NPJ Digit Med. 2023 Aug 15;6(1):146. doi: 10.1038/s41746-023-00892-x. |
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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
Anticipated start date 29th April 2025 and anticipated end date 31st of October 2025.
Vrije Universiteit Brussel (Research Stimulus Group). They will access the data through an API provided by AZ Delta Research Center.
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| ID | Term |
|---|---|
| D020918 | Complex Regional Pain Syndromes |
| ID | Term |
|---|---|
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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|
| 1 week |
| Physical Activity | Physical Activity (activity counts per time frame) is measured using the MotionWatch 8 actigraphy device (FDA-cleared, CE-marked). | 1 week |
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.
| 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). | 1 week |
| Pain condition-related medication usage | Medication intake will be recorded daily by the participant as a count of analgesic medication dosages taken. | 1 week |