Different Treatments in Chronic Pain Patients.

Recruiting

• Conditions: Chronic Pain; Nociplastic Pain
• Interventions: Other: Consultation; Procedure: Interventions; Drug: Baxter therapy; Behavioral: Interdisciplinary therapy

• Registration Number: NCT05768477
• Lead Sponsor: University Ghent

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 Timeline

• Study First Submitted: 2022-11-30
• Study First Submitted QC: 2023-03-13
• Study First Posted: 2023-03-14
• Study Start: 2023-04-06
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-06
• Primary Completion: 2026-04
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Adults
• Chronic pain patients
• Dutch speaking, or good understanding

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chronic pain patients	Interventions	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.
Chronic pain patients	Baxter therapy	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.
Chronic pain patients	Consultation	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.
Chronic pain patients	Interdisciplinary therapy	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.

Primary Outcome Measures

Name	Time	Method
Change in Pain intensity from baseline until 18 months	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	0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months	Questions
Change in Functionality from baseline until 18 months	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	0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months	EuroQol-5D questionnaire
Change in Pain disability from baseline until 18 months	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 Outcome Measures

Name	Time	Method
Change in Post exertional malaise from baseline until 18 months	0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months	Questions based on the criteria for Chronic Fatigue Syndrome.
Change in Quality of Life from baseline until 18 months	0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months	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.

Trial Locations

Locations (1)

AZ St Lucas; 🇧🇪 Ghent, Belgium