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Recruiting NCT05768477

Different Treatments in Chronic Pain Patients.

— Observational Chronic Pain Nociplastic Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Consultation, Interventions, Baxter therapy, Interdisciplinary therapy.
Who it may be relevant to
Registry conditions: Chronic Pain, Nociplastic Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Overview

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.

Interventions

  • Other Consultation
    Consultation with the pain specialist, which might entail prescription of medication of vitamins.
  • Procedure Interventions
    Facet injections, nerve denervations, infiltrations, Qutenza, Spinal Cord Stimulation, Transcutaneous Electrical Nerve Stimulation
  • Drug Baxter therapy
    Ketamine or Linisol baxter therapy
  • Behavioral Interdisciplinary therapy
    Interdisciplinary therapy provided by the physiotherapist, psychologist and occupational therapist.

Primary outcome measures

  • Change in Pain disability from baseline until 18 months [Time frame: 0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months]
  • Change in Pain intensity from baseline until 18 months [Time frame: 0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months]
  • Change in Pain Frequency from baseline until 18 months [Time frame: 0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months]
  • Change in Functionality 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]
Secondary outcome measures (2)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Belgium · 1 center
  • AZ St Lucas — Ghent

Identifiers

NCT: NCT05768477 · ONZ-2022-0090 · 2021-39

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗