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Clinical Trials/NCT05768477
NCT05768477RecruitingNot Applicable

Research of the Different Treatments for Chronic Pain Patients, Their Effectiveness and Associated Predictors, Offered at the Pain Center AZ Sint-Lucas Ghent.

University Ghent1 site in 1 country1,000 target enrollmentStarted: April 6, 2023Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
1,000
Locations
1
Primary Endpoint
Change in Pain intensity from baseline until 18 months

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Chronic pain patients
  • Dutch speaking, or good understanding

Exclusion Criteria

  • Adults unable to give consent
  • Adults who do not understand Dutch

Arms & Interventions

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.

Intervention: Consultation (Other)

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.

Intervention: Interventions (Procedure)

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.

Intervention: Baxter therapy (Drug)

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.

Intervention: Interdisciplinary therapy (Behavioral)

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

  • Change in Quality of Life from baseline until 18 months(0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months)
  • Change in Post exertional malaise from baseline until 18 months(0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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