CRPS (Complex Regional Pain Syndrome) Type I
Conditions
Keywords
Complex regional pain syndrome type 1, dorsal root ganglion stimulation, automonic outcome parameters
Brief summary
1. Objective and Rationale: The study seeks to evaluate how Dorsal Root Ganglion Stimulation (DRGS) influences autonomic functions in patients suffering from Complex Regional Pain Syndrome type I (CRPS I), offering new metrics beyond pain scores to assess therapeutic efficacy. 2. Innovative Approach: Continuous monitoring of patients using validated, CE-marked biosensors (Corsano Biosensor and Motionwatch8) to collect real-time physiological data during active DRGS therapy and therapy cessation periods. 3. Clinical Impact: Results from this study may improve patient management strategies and refine treatment protocols for individuals living with CRPS I.
Interventions
DEVICEdorsal 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.
Sponsors
AZ Delta
Vrije Universiteit Brussel
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with Complex Regional Pain Syndrome Type I (CRPS I) of the lower limbs. * Currently treated with Dorsal Root Ganglion Stimulation (DRGS). * Patients must experience \> 50% pain relief with DRGS therapy for at least three months. * Willingness and ability to comply with the study requirements, including wearing biosensors, and sharing their physiological parameters.
Exclusion criteria
* Refusal or inability to wear biosensor wearables. * Current pregnancy. * Patients with other significant medical conditions that could affect autonomic function. * Known allergies or intolerance to materials used in biosensors. * Diagnosis of untreated Obstructive Sleep Apnea Syndrome (OSAS). * Ongoing psychiatric disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate | 1 week | Heart Rate (beats per minute), measured using the Corsano Biosensor 287-2 wearable device (CE-MDR certified) |
| Heart Rate Variability | 1 week | Heart Rate Variability (milliseconds), measured using the Corsano Biosensor 287-2 wearable device (CE-MDR certified) |
| Respiratory Rate | 1 week | Respiratory Rate (breaths per minute), measured using the Corsano Biosensor 287-2 wearable device (CE-MDR certified) |
| Blood Pressure | 1 week | Non-invasive Cuffless Blood Pressure: systolic, mean and diastolic (mmHg), measured using the Corsano Biosensor 287-2 wearable device (CE-MDR certified) |
| Body Temperature | 1 week | Core Body Temperature (°C), measured using the Corsano Biosensor 287-2 wearable device (CE-MDR certified) |
| Oxygen Saturation | 1 week | Oxygen Saturation (SpO2, %), measured using the Corsano Biosensor 287-2 wearable device (CE-MDR certified) |
| Sleep Quality | 1 week | 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. |
| Physical Activity | 1 week | Physical Activity (activity counts per time frame) is measured using the MotionWatch 8 actigraphy device (FDA-cleared, CE-marked). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | 1 week | Pain intensity (patient-reported) will be assessed using the Numeric Rating Scale (NRS; 0 = no pain, 10 = worst possible pain), recorded three times daily. |
| Sleep quality | 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. |
| Patient Global Impression of Improvement | 1 week | 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). |
| Pain condition-related medication usage | 1 week | Medication intake will be recorded daily by the participant as a count of analgesic medication dosages taken. |
Countries
Belgium
Outcome results
None listed