Chronic PainEC_PC_AZSTLNCT05768477
Different Treatments in Chronic Pain Patients.
An observational study of Chronic Pain and Nociplastic Pain, run by University Ghent at 1 site in Belgium.
Trial summary
The goal of this observational study is to compare different treatment options in a chronic pain population. The main questions it aims to answer are: What is the effectiveness of the different therapy options in the pain center of Sint-Lucas on outcomes related to pain and disability? What are predictive factors for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Nociplastic Pain
- What is being tested?
- Consultation, Interventions and Baxter therapy
- Type of treatment
- Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- How many people
- 1,000 participants
- Where
- 1 siteBelgium
- Study dates
- 6 Apr 2023to 31 Dec 2027
- How long will I take part?
- 18 Months
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population will be patients attending the pain center of AZ Sint-Lucas in Ghent, a secondary care center for chronic pain patients.
Who may be able to join
- Adults
- Chronic pain patients
- Dutch speaking, or good understanding
Who cannot join
- Adults unable to give consent
- Adults who do not understand Dutch
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
AZ St Lucas
Ghent, 9000
Elise Cnockaert, Elise.Cnockaert@azstlucas.be
Elise Cnockaert
About this study
Official title: Research of the Different Treatments for Chronic Pain Patients, Their Effectiveness and Associated Predictors, Offered at the Pain Center AZ Sint-Lucas Ghent.
The goal of this observational study is to compare different treatment options in a chronic pain population. The main questions it aims to answer are:
- What is the effectiveness of the different therapy options in the pain center of Sint-Lucas on outcomes related to pain and disability?
- What are predictive factors for the different therapy options in the pain center of Sint-Lucas? Which factors predict improvement in pain related outcomes?
Read more
Participant data will be gathered as part of their routine care. They can be advised to 4 different treatment options:
- Consultations with the pain specialist
- Interventions by the pain specialist (infiltrations, denervations)
- Baxter therapy
- Interdisciplinary treatment
Researchers will compare patients with different dominant pain mechanisms to see which treatment are most effective for which dominant pain mechanisms.
Read the detailed description
The aim of the present study is to describe the natural flow of the chronic pain patients at the pain center AZ Sint-Lucas. Patients will be examined before starting the therapy, and receive standardized questionnaires at several fixed time points (before, during, and after their therapy trajectory). Information about the present dominant pain mechanism will be gathered during the examination. The questionnaires will gather demographic data, information about the present dominant pain mechanism, psychosocial factors, catastrophizing, fear and avoidance, illness perceptions, fatigue and information about therapy success. During the examination, typical signs of a dominant nociplastic pain mechanism will be gathered. By processing the data of the questionnaires and the examination, knowledge about (1) the amount of patients with a dominant nociplastic pain mechanism at intake, (2) the treatment trajectory for a specific diagnosis, and (3) the prediction of the therapy effect and prognosis will be obtained.
- Conditions
- Chronic Pain, Nociplastic Pain
- Being tested
- Consultation, Interventions, Baxter therapy, Interdisciplinary therapy
- Medical subject headings
- Chronic Pain, Nociplastic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConsultationOther
Consultation with the pain specialist, which might entail prescription of medication of vitamins.
InterventionsProcedure or surgery
Facet injections, nerve denervations, infiltrations, Qutenza, Spinal Cord Stimulation, Transcutaneous Electrical Nerve Stimulation
Baxter therapyDrug
Ketamine or Linisol baxter therapy
Interdisciplinary therapyBehavioural
Interdisciplinary therapy provided by the physiotherapist, psychologist and occupational therapist.
| Study group | Role | What they receive |
|---|---|---|
| Chronic pain patients | Chronic pain patients with a dominant nociceptive pain mechanism, a dominant neuropathic pain mechanism and a dominant nociplastic pain mechanism. They will receive different treatments: Consultations, Interventions (injections, denervations...), Baxter therapy and interdisciplinary treatment. Receives: Other: Consultation; Procedure: Interventions; Drug: Baxter therapy; Behavioral: Interdisciplinary therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain disability from baseline until 18 months
Pain Disability Index, ranges from zero to 70, with a higher score indicating more pain-related disability
Measured: 0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months
Change in Pain intensity from baseline until 18 months
Numeric Rating Scale for pain intensity in the past week, ranges from zero to 100, with a higher score indicating a higher pain intensity
Measured: 0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months
Change in Pain Frequency from baseline until 18 months
Questions
Measured: 0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months
Change in Functionality from baseline until 18 months
Patient Specific Complaints questionnaire, using a Numeric Rating Scale, ranging from zero to 100, with a higher score indicating a higher amount of functional disability
Measured: 0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months
Change in Quality of Life from baseline until 18 months
EuroQol-5D questionnaire
Measured: 0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months
Secondary outcomes (2)
Change in Post exertional malaise from baseline until 18 months
Questions based on the criteria for Chronic Fatigue Syndrome.
Measured: 0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months
Change in Quality of Life from baseline until 18 months
EuroQol - 5D, five questions about health range from one to three with a higher score indicating more difficulties. One question about perceived health ranges from zero to 100 with a higher score indicating better health.
Measured: 0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start6 Apr 2023
- Primary completionSep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- 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
- 1,000 participants (estimated)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica Van Oosterwijck, Principal investigator, Department of Rehabilitation Sciences, Faculty of Health Sciences, Ghent University, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05768477
- Sponsor's protocol ID
- ONZ-2022-0090
- Other IDs
- 2021-39
- Acronym
- EC_PC_AZSTL
- Status last verified
- Nov 2026
- First submitted
- 30 Nov 2022
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The personal data will be shared with the personal electronic patient file of AZ Sint-Lucas, of each patient. Sharing of data will be done upon reasonable request, and only for research purposes, after publication of the results. Data will be shared via a restricted data repository (FAIRsharing.org)
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research of the Different Treatments for Chronic Pain Patients, Their Effectiveness and Associated Predictors, Offered at the Pain Center AZ Sint-Lucas Ghent.
- ClinicalTrials.gov ID
- NCT05768477
- Acronym / sponsor ID
- EC_PC_AZSTL / ONZ-2022-0090
- Conditions
- Chronic Pain, Nociplastic Pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 6 Apr 2023 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 14 Mar 2023 (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.
The goal of this observational study is to compare different treatment options in a chronic pain population. The main questions it aims to answer are:
- What is the effectiveness of the different therapy options in the pain center of Sint-Lucas on outcomes related to pain and disability?
- What are predictive factors for the different therapy options in the pain center of Sint-Lucas? Which factors predict improvement in pain related outcomes?
Participant data will be gathered as part of their routine care. They can be advised to 4 different treatment options:
- Consultations with the pain specialist
- Interventions by the pain specialist (infiltrations, denervations)
- Baxter therapy
- Interdisciplinary treatment
Researchers will compare patients with different dominant pain mechanisms to see which treatment are most effective for which dominant pain mechanisms.
Detailed description
The aim of the present study is to describe the natural flow of the chronic pain patients at the pain center AZ Sint-Lucas. Patients will be examined before starting the therapy, and receive standardized questionnaires at several fixed time points (before, during, and after their therapy trajectory). Information about the present dominant pain mechanism will be gathered during the examination. The questionnaires will gather demographic data, information about the present dominant pain mechanism, psychosocial factors, catastrophizing, fear and avoidance, illness perceptions, fatigue and information about therapy success. During the examination, typical signs of a dominant nociplastic pain mechanism will be gathered. By processing the data of the questionnaires and the examination, knowledge about (1) the amount of patients with a dominant nociplastic pain mechanism at intake, (2) the treatment trajectory for a specific diagnosis, and (3) the prediction of the therapy effect and prognosis will be obtained.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic pain patients | – | Other: Consultation, Procedure: Interventions, Drug: Baxter therapy, Behavioral: Interdisciplinary therapyChronic pain patients with a dominant nociceptive pain mechanism, a dominant neuropathic pain mechanism and a dominant nociplastic pain mechanism. They will receive different treatments: Consultations, Interventions (injections, denervations...), Baxter therapy and interdisciplinary treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population will be patients attending the pain center of AZ Sint-Lucas in Ghent, a secondary care center for chronic pain patients.
Key inclusion criteria (3 listed)
- Adults
- Chronic pain patients
- Dutch speaking, or good understanding
Key exclusion criteria (2 listed)
- Adults unable to give consent
- Adults who do not understand Dutch
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 |
|---|---|---|
| ConsultationConsultation with the pain specialist, which might entail prescription of medication of vitamins. | Other | Chronic pain patients |
| InterventionsFacet injections, nerve denervations, infiltrations, Qutenza, Spinal Cord Stimulation, Transcutaneous Electrical Nerve Stimulation | Procedure or surgery | Chronic pain patients |
| Baxter therapyKetamine or Linisol baxter therapy | Drug | Chronic pain patients |
| Interdisciplinary therapyInterdisciplinary therapy provided by the physiotherapist, psychologist and occupational therapist. | Behavioural | Chronic pain patients |
Primary outcome
Change in Pain disability from baseline until 18 months
Time frame: 0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months
Pain Disability Index, ranges from zero to 70, with a higher score indicating more pain-related disability
Change in Pain intensity from baseline until 18 months
Time frame: 0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months
Numeric Rating Scale for pain intensity in the past week, ranges from zero to 100, with a higher score indicating a higher pain intensity
Change in Pain Frequency from baseline until 18 months
Time frame: 0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months
Questions
Change in Functionality from baseline until 18 months
Time frame: 0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months
Patient Specific Complaints questionnaire, using a Numeric Rating Scale, ranging from zero to 100, with a higher score indicating a higher amount of functional disability
Change in Quality of Life from baseline until 18 months
Time frame: 0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months
EuroQol-5D questionnaire
2 secondary outcomes
Change in Post exertional malaise from baseline until 18 months
Time frame: 0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months
Change in Quality of Life from baseline until 18 months
Time frame: 0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months
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 3 Nov 2026.
- Individual participant dataSharing planned: Yes. The personal data will be shared with the personal electronic patient file of AZ Sint-Lucas, of each patient. Sharing of data will be done upon reasonable request, and only for research purposes, after publication of the results. Data will be shared via a restricted data repository (FAIRsharing.org)
Related trials for Chronic Pain
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
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.
Jessica Van Oosterwijck principal investigator
Department of Rehabilitation Sciences, Faculty of Health Sciences, Ghent University, Belgium
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 and Nociplastic Pain, run by University Ghent 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 3 inclusion and 2 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 3 Nov 2026. 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 Jessica Van Oosterwijck, Professor (+32 9 332 69 19, jessica.vanoosterwijck@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain disability from baseline until 18 months (time frame: 0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2026.