Chronic Pain SyndromesNCT06835868
Neuro-Pain Provides a Dynamic and Interactive Register for the Invasvive Neuromodulatory Therapies for Different Chronic Pain Syndromes. Patients Living in Belgium and Suffering From Persistent Spinal Pain Syndromes Type 2 as Well as Suffering From Complex Regional Pain Syndromes Are Included.
An observational study of Chronic Pain Syndromes and CRPS, run by University Hospital, Antwerp at 1 site in Belgium.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Pain Syndromes, CRPS
- What is being tested?
- Spinal cord stimulation
- Type of treatment
- Surgery or procedure
- How many people
- 7,000 participants
- Where
- 1 siteBelgium
- Study dates
- 14 Feb 2018to 1 Jan 2032
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult patients suffering from chronic pain syndromes, either persistent spinal pain syndromes or complex regional pain syndromes.
Who may be able to join
- chronic pain syndromes
Who cannot join
- acute pain syndromes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UZA, multidisciplinary pain center
Edegem, Antwerp, 2650
Guy H Hans, MD, PhD, 003238213000, pijncentrum@uza.be
Davina Wildemeersch, MD, PhD, davina.wildemeersch@uza.be
About this study
Official title: Nationwide Dynamic Register for Screening, Evaluation and Follow-up of Patients Suffering From Chronic Pain Syndromes and Treated by Means of Invasive Neuromodulation.
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.
- Conditions
- Chronic Pain Syndromes, CRPS
- Being tested
- Spinal cord stimulation
- Keywords
- spinal cord stimulation, chronic pain, quality of life
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal cord stimulationProcedure or surgery
implantation of electrode which is linked to an implantable impulse generator for the treatment of chronic pain syndromes.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start14 Feb 2018
- Primary completion31 Jan 2030 (estimated)
- Study completion1 Jan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Pain SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06835868
- Sponsor's protocol ID
- Neuro-Pain
- Status last verified
- Feb 2025
- First submitted
- 14 Feb 2025
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40791635
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nationwide Dynamic Register for Screening, Evaluation and Follow-up of Patients Suffering From Chronic Pain Syndromes and Treated by Means of Invasive Neuromodulation.
- ClinicalTrials.gov ID
- NCT06835868
- Acronym / sponsor ID
- Neuro-Pain
- Conditions
- Chronic Pain Syndromes, CRPS
- Keywords
- spinal cord stimulation, chronic pain, quality of life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 7,000 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- 14 Feb 2018 (actual)
- Primary completion
- 31 Jan 2030 (estimated)
- Study completion
- 1 Jan 2032 (estimated)
- First posted
- 19 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patients suffering from chronic pain syndromes, either persistent spinal pain syndromes or complex regional pain syndromes.
Key inclusion criteria (1 listed)
- chronic pain syndromes
Key exclusion criteria (1 listed)
- acute pain syndromes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal cord stimulationimplantation of electrode which is linked to an implantable impulse generator for the treatment of chronic pain syndromes. | Procedure or surgery | – |
Primary outcome
Pain intensity after 21 days
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Derived from this study: PubMed 40791635Bernaerts 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain Syndromes and CRPS, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guy H HANS, MD, PhD (003238213000 ext. 4945, guy.hans@uza.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity after 21 days (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06835868, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.