Different Treatments in Chronic Pain Patients.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Ghent

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults

Chronic pain patients

Dutch speaking, or good understanding

Disqualifiers

Adults unable to give consent

Adults who do not understand Dutch

Trial population

The population will be patients attending the pain center of AZ Sint-Lucas in Ghent, a secondary care center for chronic pain patients.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Consultation

    Other intervention

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

  • Interventions

    Procedure/Surgery

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

  • Baxter therapy

    Drug

    Ketamine or Linisol baxter therapy

  • Interdisciplinary therapy

    Behavioral

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

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: Chronic pain patients4 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months
2

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

Time frame
0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months
3

Change in Pain Frequency from baseline until 18 months

Questions

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

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

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

Secondary outcomes

1

Change in Post exertional malaise from baseline until 18 months

Questions based on the criteria for Chronic Fatigue Syndrome.

Time frame
0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months
2

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.

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

Other outcomes

Sponsors and contacts

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