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临床试验/NCT04657159
NCT04657159已完成不适用

Health-economic Evaluation of Interventional Pain Management Compared to Pain Rehabilitation

Eques Indolor AB2 个研究点 分布在 1 个国家目标入组 15,611 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15,611
试验地点
2
主要终点
Health-related quality of life

研究概览

简要总结

The overall aim of the study is to evaluate interventional pain management. This is done in three steps:

  1. To find matched controls to the patients in the study on cost-effectiveness of IPM and compare the results.
  2. To calculate cost-effectiveness of PRP during the period 2010-2016, on a national level.
  3. To calculate cost-effectiveness of PRP during the period 2017-2019, after the changed guidelines for PRP in Sweden.

The two last steps are to provide a background to the results of IPM, and to see if the results in the subgroup of matched controls of PRP-patients differ from the results from the whole population.

详细描述

Chronic pain is one of the major health problems globally, according to the WHO 'global burden of disease' studies. Previously, the investigators have performed a study on a feasible approach to be able to treat zygapophyseal joint pain in the thoracic region, similar to the established methods for treatment in the lumbar and cervical regions which have been published. The study showed that there was a significant improvement in health related quality of life (HRQoL) after treatment, and that there were no difference in the results depending on if it was the cervical, thoracic or lumbar region that was treated. The study had ethical approval (Dnr 2012-446-31M) and is registered here at clinicaltrials.gov.

Another study explored the health economic aspects of interventional pain management (IPM). The investigators aimed to do this in comparison with pain rehabilitation programs, and therefore further ethical approval was searched and gained (2012-446-31M, 2017-542-32, 2018- 507-32) An health-economic evaluation of only IPM was performed showing that patients after treatment of diagnosed pain-focuses in zygapophyseal joint pain not only improve their HRQoL but they also reduce their medication, reduced their health-care consumption and gained in ability to work. The cost per quality adjusted life years gained was below the threshold for cost-effective health-care according to the threshold-levels defined by the national Board of Health and Welfare in Sweden. But the investigators need a larger population to select from in order to get matched controls among patients that have been through pain rehabilitation programs.

This study therefore aims to explore the national register of pain rehabilitation both in order to find matched controls and in order to make a cost-effectiveness study of pain rehabilitation program as it is performed in Sweden.

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 94 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Been through pain rehabilitation program

排除标准

  • 未提供

结局指标

主要结局

Health-related quality of life

时间窗: 1 year

EQ-5D index

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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