Different Treatments in Chronic Pain Patients.

NCT05768477 | Recruiting

• 2 other identifiers: ONZ-2022-00902021-39
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Nociplastic Pain

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Change in Post exertional malaise from baseline until 18 months

  0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months

• Change in Quality of Life from baseline until 18 months

  0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months

Study Arms (1)

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.

Other: Consultation; Procedure: Interventions; Drug: Baxter therapy; Behavioral: Interdisciplinary therapy

Interventions

Consultation OTHER

Consultation with the pain specialist, which might entail prescription of medication of vitamins.

Chronic pain patients

Interventions PROCEDURE

Facet injections, nerve denervations, infiltrations, Qutenza, Spinal Cord Stimulation, Transcutaneous Electrical Nerve Stimulation

Chronic pain patients

Baxter therapy DRUG

Ketamine or Linisol baxter therapy

Chronic pain patients

Interdisciplinary therapy BEHAVIORAL

Interdisciplinary therapy provided by the physiotherapist, psychologist and occupational therapist.

Chronic pain patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

AZ St Lucas

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Nociplastic Pain

Interventions

Referral and Consultation; Methods

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration; Investigative Techniques

Study Officials

• Jessica Van Oosterwijck

  Department of Rehabilitation Sciences, Faculty of Health Sciences, Ghent University, Belgium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Van Oosterwijck, Professor

CONTACT

+32 9 332 69 19; jessica.vanoosterwijck@ugent.be

Elise Cnockaert

CONTACT

+32 9 332 56 35; elise.cnockaert@ugent.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: March 14, 2023
• Study Start: April 6, 2023
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 6, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• 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.
• Access Criteria: The data will not be transferred to a third country.

Locations

BE (1)