Different Treatments in Chronic Pain Patients. (EC_PC_AZSTL)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain; Nociplastic Pain
• Intervention / Treatment: Procedure: Interventions; Behavioral: Interdisciplinary therapy; Other: Consultation; Drug: Baxter therapy

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 Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Jessica Van Oosterwijck, Professor; Phone Number: +32 9 332 69 19; Email: jessica.vanoosterwijck@ugent.be
• Study Contact Backup: Name: Elise Cnockaert; Phone Number: +32 9 332 56 35; Email: elise.cnockaert@ugent.be

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Recruiting
    • AZ St Lucas
    • Contact: Elise Cnockaert; Email: Elise.Cnockaert@azstlucas.be
    • Principal Investigator: Elise Cnockaert

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain disability from baseline until 18 months	Pain Disability Index, ranges from zero to 70, with a higher score indicating more pain-related disability	0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months
Change in Pain intensity from baseline until 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	0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months
Change in Pain Frequency from baseline until 18 months	Questions	0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months
Change in Functionality from baseline until 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	0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months
Change in Quality of Life from baseline until 18 months	EuroQol-5D questionnaire	0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Ghent
• Investigators: Principal Investigator: Jessica Van Oosterwijck, Department of Rehabilitation Sciences, Faculty of Health Sciences, Ghent University, Belgium

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2023
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: November 30, 2022
• First Submitted That Met QC Criteria: March 13, 2023
• First Posted (Actual): March 14, 2023

Study Record Updates

• Last Update Posted (Actual): June 6, 2024
• Last Update Submitted That Met QC Criteria: June 5, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: ONZ-2022-0090; 2021-39 (Registry Identifier: AZ Sint Lucas Hospital Ghent)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The personal data will be shared with the personal electronic patient file of AZ Sint-Lucas, of each patient.

Sharing of data will be done upon reasonable request, and only for research purposes, after publication of the results. Data will be shared via a restricted data repository (FAIRsharing.org)

• IPD Sharing Time Frame: The data will not be transferred to a third country. The ethical committee of the pain center of AZ Sint-Lucas did not allow for data transfer upon reasonable request.
• IPD Sharing Access Criteria: The data will not be transferred to a third country.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No