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临床试验/NCT05768477
NCT05768477招募中不适用

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

University Ghent1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2023年4月6日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
1
主要终点
Change in Pain intensity from baseline until 18 months

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chronic pain patients
  • Dutch speaking, or good understanding

排除标准

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

研究组 & 干预措施

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.

干预措施: Consultation (Other)

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.

干预措施: Interventions (Procedure)

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.

干预措施: Baxter therapy (Drug)

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.

干预措施: Interdisciplinary therapy (Behavioral)

结局指标

主要结局

Change in Pain intensity from baseline until 18 months

时间窗: 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

Change in Pain Frequency from baseline until 18 months

时间窗: 0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months

Questions

Change in Functionality from baseline until 18 months

时间窗: 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

Change in Quality of Life from baseline until 18 months

时间窗: 0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months

EuroQol-5D questionnaire

Change in Pain disability from baseline until 18 months

时间窗: 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

次要结局

  • Change in Quality of Life from baseline until 18 months(0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months)
  • Change in Post exertional malaise from baseline until 18 months(0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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