A prospective single-centre study to assess the effectiveness of Closed-Loop Spinal Cord Stimulation (CL-SCS) in the treatment of chronic pain associated with primary and secondary Raynaud's Phenomenon

A prospective single-centre study to assess the effectiveness of Closed-Loop Spinal Cord Stimulation (CL-SCS) in the treatment of chronic pain associated with primary and secondary Raynaud's Phenomenon - Closed-Loop SCS for the treatment of chronic pain associated with Raynaud's Phenomenon

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00030179

Enrollment

Registered

2022-09-06

Start date

2021-06-01

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Raynaud's phenomenon Chronic pain

Interventions

Group 1: Patients with Raynaud's phenomenon will be treated with closed-loop SCS to assess the effectiveness of closed-loop SCS in the treatment of Raynaud's phenomenon.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Confirmed diagnosis of either primary or secondary RP - Able to provide informed consent to participate in the study in accordance with Section 20, paragraph 2 of the MPG - Deemed able to operate the system - Deemed a suitable surgical candidate for SCS implantation - 18 years or older - Not pregnant or nursing - Not allergic, or have shown hypersensitivity, to any of the materials of the neurostimulation system which come in contact with the body - Average baseline frequency of =>2 Raynaud's attacks per week and/or an average severity of =>5

Exclusion criteria

Exclusion criteria: - BMI =>35 - Poorly adjusted arterial hypertension (at rest >170/100 mmHG) - Unstable coronary heart disease - Acute myocardial infarction within the last twelve weeks - Acute infection of trophic skin changes - Circumstances that do not guarantee the subject's ability to cooperate (compliance, self motivation, physical mobility, social environment) - Planned heart surgery, joint prosthetic or other mobility-restricting surgery in the next 3-months - Participation in another study with an active therapy arm - Missing hand-signed and dated consent

Design outcomes

Primary

Measure	Time frame
Percentage change in severity and frequency of Raynaud attacks will be assesses by paper CRFs at 3-months.	—

Secondary

Measure	Time frame
Evaluate the effect of CL-SCS on: - Symptoms associated with RP (Raynaud symptom map, Raynaud's Condition Score (RCS), VAS for pain) - Health related quality of life (EQ-5D-5L) - Function (Cochin Hand function Scale, SHAQ) - Peripheral circulation (doppler ultrasound, ulcers) - Subject satisfaction (PGIC scale) - Medication (changes in types and dosages) - Stimulation programming characteristics (stimulation settings) - Safety (incidence device related adverse events)	—

Measure

Time frame

Evaluate the effect of CL-SCS on: - Symptoms associated with RP (Raynaud symptom map, Raynaud's Condition Score (RCS), VAS for pain) - Health related quality of life (EQ-5D-5L) - Function (Cochin Hand function Scale, SHAQ) - Peripheral circulation (doppler ultrasound, ulcers) - Subject satisfaction (PGIC scale) - Medication (changes in types and dosages) - Stimulation programming characteristics (stimulation settings) - Safety (incidence device related adverse events)

—

Countries

Germany

Contacts

Public ContactJaroslaw Maciaczyk

Leiter der Sektion Stereotaktische und Funktionelle Neurochirurgie der Neurochirurgischen Klinik, Universitätsklinikum Bonn

jaroslaw.maciaczyk@ukbonn.de+49 228 287-16531

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026