NCT06835868

Brief Summary

Patients suffereing from chronic pain due to persistent spinal pain syndromes or complex regional pain syndromes and living in Belgium will be included in this register once they are being considered for a treatment with invasive neuromodulation (either spinal cord stimulation either dorsal root ganglion stimulation). The screening process, the multidisciplinary evaluation, the trial therapy and the long-terl follow-up will be monitored through this register.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,000

participants targeted

Target at P75+ for all trials

Timeline
69mo left

Started Feb 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Feb 2018Jan 2032

Study Start

First participant enrolled

February 14, 2018

Completed
7 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 19, 2025

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2030

Expected
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2032

Last Updated

March 4, 2025

Status Verified

February 1, 2025

Enrollment Period

12 years

First QC Date

February 14, 2025

Last Update Submit

February 27, 2025

Conditions

Keywords

spinal cord stimulationchronic painquality of life

Outcome Measures

Primary Outcomes (1)

  • Pain intensity after 21 days

    Follow-up of pain intensity (measured by the Numeric Rating Scale, with a minimum of 0 and a maximum score of 10) during the trial therapy of 21 days, together with quality of sleep and quality of ambulation (also ona NRS scale from 0 to 10).

    21 days

Interventions

implantation of electrode which is linked to an implantable impulse generator for the treatment of chronic pain syndromes.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients suffering from chronic pain syndromes, either persistent spinal pain syndromes or complex regional pain syndromes.

You may qualify if:

  • chronic pain syndromes

You may not qualify if:

  • acute pain syndromes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZA, multidisciplinary pain center

Edegem, Antwerp, 2650, Belgium

RECRUITING

Related Publications (1)

  • Bernaerts L, Roelant E, Moens M, Ly HG, Buyten JV, Billet B, Bryon B, Puylaert M, Tuna T, Malone M, Theys T, Berquin A, Vangeneugden J, Hans G. Multidisciplinary Approach to Spinal Cord Stimulation for Persistent Spinal Pain Syndromes: A 65-Month Integrated Data Collection From the Belgian Neuro-Pain(R) Real-World Data Register. Pain Res Manag. 2025 Aug 4;2025:7880611. doi: 10.1155/prm/7880611. eCollection 2025.

MeSH Terms

Conditions

Chronic Pain

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitation

Central Study Contacts

Guy H HANS, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2025

First Posted

February 19, 2025

Study Start

February 14, 2018

Primary Completion (Estimated)

January 31, 2030

Study Completion (Estimated)

January 1, 2032

Last Updated

March 4, 2025

Record last verified: 2025-02

Locations