EC_PC_AZSTL: Different Treatments in Chronic Pain Patients.

Sponsor
University Ghent (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05768477
Collaborator
(none)
1,000
48

Study Details

Study Description

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)

  • Bakster therapy

  • Interdisciplinary treatment

Researchers will compare patients with different dominant pain mechanisms to see which treatment are most effective for which dominant pain mechanisms.

Condition or Disease Intervention/Treatment Phase
  • Other: Consultation
  • Procedure: Interventions
  • Drug: Baxter therapy
  • Behavioral: Interdisciplinary 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 receive online standardized questionnaires at several fixed timepoints (during and after their therapy trajectory). Fixed follow-up measurements are chosen since each patient receives an individual and different treatment, whereby the end point of the treatment will differ for every patient. These questionnaires will gather demographic data, information about the present dominant pain mechanism, the presence of psychosocial factors, catastrophizing, fear and avoidance, illness perceptions, fatigue and information about therapy success. By processing the data of the questionnaires, 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 [Patient Registry]
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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.
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2026
Anticipated Study Completion Date :
Apr 1, 2027

Arms and Interventions

Arm 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...), Bakster therapy and interdisciplinary treatment.

Other: Consultation
Consultation with the pain specialist, which might entail prescrition of medication of vitamins.

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

Drug: Baxter therapy
Ketamin or Linisol baxter therapy

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

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

  3. Change in Pain Frequency from baseline until 18 months [0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months]

    Questions

  4. 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

Secondary Outcome Measures

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Adults

  • Chronic pain patients

  • Dutch speaking, or good understanding

Exclusion Criteria:
  • Adults unable to give consent

  • Adults who do not understand Dutch

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Ghent

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Ghent
ClinicalTrials.gov Identifier:
NCT05768477
Other Study ID Numbers:
  • ONZ-2022-0090
  • 2021-39
First Posted:
Mar 14, 2023
Last Update Posted:
Mar 14, 2023
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 14, 2023