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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-39 | Registry Identifier | AZ Sint Lucas Hospital Ghent |
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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:
Participant data will be gathered as part of their routine care. They can be advised to 4 different treatment options:
Researchers will compare patients with different dominant pain mechanisms to see which treatment are most effective for which dominant pain mechanisms.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Consultation | Other | Consultation with the pain specialist, which might entail prescription of medication of vitamins. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months |
| Change in Pain Frequency from baseline until 18 months | Questions | 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 | 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 | 0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Post exertional malaise from baseline until 18 months | Questions based on the criteria for Chronic Fatigue Syndrome. | 0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months |
| Change in Quality of Life from baseline until 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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The population will be patients attending the pain center of AZ Sint-Lucas in Ghent, a secondary care center for chronic pain patients.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessica Van Oosterwijck, Professor | Contact | +32 9 332 69 19 | jessica.vanoosterwijck@ugent.be | |
| Elise Cnockaert | Contact | +32 9 332 56 35 | elise.cnockaert@ugent.be |
| Name | Affiliation | Role |
|---|---|---|
| Jessica Van Oosterwijck | Department of Rehabilitation Sciences, Faculty of Health Sciences, Ghent University, Belgium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ St Lucas | Recruiting | Ghent | 9000 | Belgium |
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)
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The data will not be transferred to a third country. The ethical committee of the pain center of AZ Sint-Lucas did not allow for data transfer upon reasonable request.
The data will not be transferred to a third country.
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D000098653 | Nociplastic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012017 | Referral and Consultation |
| D008722 | Methods |
| ID | Term |
|---|---|
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
| D008919 | Investigative Techniques |
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| Interventions | Procedure | Facet injections, nerve denervations, infiltrations, Qutenza, Spinal Cord Stimulation, Transcutaneous Electrical Nerve Stimulation |
|
| Baxter therapy | Drug | Ketamine or Linisol baxter therapy |
|
| Interdisciplinary therapy | Behavioral | Interdisciplinary therapy provided by the physiotherapist, psychologist and occupational therapist. |
|
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.
| 0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months |