Clinical trial NCT05768477: Different Treatments in Chronic Pain Patients.
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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Pain
Nociplastic Pain
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2023-03-14
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.

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

Primary outcomes:
measure: Change in Pain disability from baseline until 18 months
timeFrame: 0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months
measure: Change in Pain intensity from baseline until 18 months
timeFrame: 0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months
measure: Change in Pain Frequency from baseline until 18 months
timeFrame: 0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months
measure: Change in Functionality from baseline until 18 months
timeFrame: 0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months
measure: Change in Quality of Life from baseline until 18 months
timeFrame: 0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months
Secondary outcomes:
measure: Change in Post exertional malaise from baseline until 18 months
timeFrame: 0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months
measure: Change in Quality of Life from baseline until 18 months
timeFrame: 0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: AZ St Lucas
Study officials:
affiliation: Department of Rehabilitation Sciences, Faculty of Health Sciences, Ghent University, Belgium
name: Jessica Van Oosterwijck
role: PRINCIPAL_INVESTIGATOR
References: