Different Treatments in Chronic Pain Patients.

Chronic Pain Clinical Trial

— EC_PC_AZSTL  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05768477
• Other study ID #: ONZ-2022-0090
• Secondary ID: 2021-39
• Status: Recruiting
• Start date: April 6, 2023
• Est. completion date: June 30, 2027

Study information

• Verified date: June 2024
• Source: University Ghent
• Contact: Jessica Van Oosterwijck, Professor
• Phone: +32 9 332 69 19
• Email: jessica.vanoosterwijck[@]ugent.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 30, 2027
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults

• Chronic pain patients

• Dutch speaking, or good understanding

Exclusion Criteria:

• Adults unable to give consent

• Adults who do not understand Dutch

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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.

Locations

Country	Name	City	State
Belgium	AZ St Lucas	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Change in Pain Frequency from baseline until 18 months	Questions	0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months
Primary	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
Primary	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	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
Secondary	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