Physiological Parameters in CRPS Patients Treated With Dorsal Root Ganglion Stimulation

Not Applicable

Active, not recruiting

• Conditions: CRPS (Complex Regional Pain Syndrome) Type I

• Registration Number: NCT07147140
• Lead Sponsor: AZ Delta

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-14
• Study Start: 2025-04-15
• Study First Submitted QC: 2025-08-26
• Last Update Submitted: 2025-08-26
• Study First Posted: 2025-08-28
• Last Update Posted: 2025-08-28
• Primary Completion: 2025-10-31
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Heart Rate	1 week	Heart Rate (beats per minute), measured using the Corsano Biosensor 287-2 wearable device (CE-MDR certified)
Physical Activity	1 week	Physical Activity (activity counts per time frame) is measured using the MotionWatch 8 actigraphy device (FDA-cleared, CE-marked).
Heart Rate Variability	1 week	Heart Rate Variability (milliseconds), 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)
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.
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)
Oxygen Saturation	1 week	Oxygen Saturation (SpO2, %), measured using the Corsano Biosensor 287-2 wearable device (CE-MDR certified)

Secondary Outcome Measures

Name	Time	Method
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.
Pain condition-related medication usage	1 week	Medication intake will be recorded daily by the participant as a count of analgesic medication dosages taken.
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).

Trial Locations

Locations (1)

AZ Delta; 🇧🇪 Roeselare, Belgium