Clinical trial
Research of the Different Treatments for Chronic Pain Patients, Their Effectiveness and Associated Predictors, Offered at the Pain Center AZ Sint-Lucas Ghent.
Name
ONZ-2022-0090
Description
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.
Trial arms
Trial start
2023-04-06
Estimated PCD
2026-04-01
Trial end
2027-06-30
Status
Recruiting
Treatment
Consultation
Consultation with the pain specialist, which might entail prescription of medication of vitamins.
Arms:
Chronic pain patients
Interventions
Facet injections, nerve denervations, infiltrations, Qutenza, Spinal Cord Stimulation, Transcutaneous Electrical Nerve Stimulation
Arms:
Chronic pain patients
Baxter therapy
Ketamine or Linisol baxter therapy
Arms:
Chronic pain patients
Interdisciplinary therapy
Interdisciplinary therapy provided by the physiotherapist, psychologist and occupational therapist.
Arms:
Chronic pain patients
Size
1000
Primary endpoint
Change in Pain disability from baseline until 18 months
0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months
Change in Pain intensity from baseline until 18 months
0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months
Change in Pain Frequency from baseline until 18 months
0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months
Change in Functionality from baseline until 18 months
0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months
Change in Quality of Life from baseline until 18 months
0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months
Eligibility criteria
Inclusion Criteria:
* Adults
* Chronic pain patients
* Dutch speaking, or good understanding
Exclusion Criteria:
* Adults unable to give consent
* Adults who do not understand Dutch
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '18 Months', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 1000, 'type': 'ESTIMATED'}}
Updated at
2024-06-06
1 organization
1 product
2 indications
Organization
Ghent UniversityProduct
BaxterIndication
Chronic PainIndication
Nociplastic Pain