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Quantifying various effects of closed-loop Spinal Cord Stimulation (SCS) on pathophysiological mechanisms in Complex Regional Pain Syndrome (CRPS); an explorative study

Quantifying various effects of closed-loop Spinal Cord Stimulation (SCS) on pathophysiological mechanisms in Complex Regional Pain Syndrome (CRPS); an explorative study - Closed-loop SCS for CRPS

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON49652
Enrollment
20
Registered
2020-08-18
Start date
2020-12-09
Completion date
Unknown
Last updated
2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

complex regional pain syndrome reflex sympathetic dystrophy

Interventions

Patients will receive standard care and will have all the standard follow-up visits and two additional visits. At every visit standard data is collected. However, at baseline and each follow-up visi

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: a subject must meet the standard Dutch Neuromodulation Society consensus criteria for spinal cord stimulation and the following study criteria:, - Over 18 year old - Diagnosed with retractable unilateral, upper- or lower limp CRPS, - Capable and willing to participate in the additional measurements.

Exclusion criteria

Exclusion criteria: - Pain of other aetiology in addition to CRPS, - Previously failed neuromodulation treatment (SCS or DRG).

Design outcomes

Primary

MeasureTime frame
The primary study parameter is the change in pain intensity at the end of the study compared with baseline.

Secondary

MeasureTime frame
Changes between the end of the study and baseline on all other parameters will be assessed and reported as secondary endpoints for this study.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)