跳至主要内容
临床试验/NCT03108339
NCT03108339已完成不适用

Markers of Outcome - a Cohort Study of LBP in Primary Health Care

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2018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
70
试验地点
1
主要终点
Pain level

研究概览

简要总结

Low-back pain (LBP) is a complex and heterogeneous disorder commonly seen in primary health care. Despite a variety of treatment options available, it seems that few of these prevent recurrent LBP and chronicity. In addition, when comparing different treatment options, effect sizes are not impressive, indicating that we either lack effective treatment for LBP, diagnose poorly or that we measure the outcome of treatment incorrectly. Sub groups within the heterogeneous group suffering from LBP need to be identified and also markers influencing treatment efficacy. The project aims to conduct a cohort study with the objective to identify prognostic markers and sub groups for a successful or poor outcome of low-back pain and disability in short and long term. We aim to follow the trajectory of pain, to study interactions of markers and associations with days of pain and activity level. We will include people seeking physiotherapy care for a primary complaint of LBP to collect data on a core set of outcome measurements concerning pain, functional limitations, health and quality of life, self- efficacy and fear avoidance. The data will be collected at baseline, at 8 weeks and 6 and 12 months following an intervention of guideline recommended physiotherapeutic care comprising information to "stay active" and exercises enhancing core stability supervised by experienced physiotherapist. We aim to collect data on movement control of the lower back and general excessive mobility of the joints at base line. We will collect longitudinal data on days with troublesome pain and activity level through text-messages sent every 2 weeks. We will analyze the data with mixed model regression analyses and cluster analyses to be able to identify predictive factors and interactions to sub group the participants.

详细描述

OVERALL AIM This project aims to through a praxis study (aim 1), a cohort study of markers of outcome (aim 2) tailor a patient cantered physiotherapy primary health care intervention (aim 3) in a randomized controlled trial.

  1. Through a praxis study evaluate how physiotherapists in primary care use patient reported instruments and clinical tests when targeting treatment in LBP.
  2. To conduct a nation-wide cohort study in primary care to identify markers at baseline to predict a poor or a successful outcome of LBP in the long term of 12 months following physiotherapeutic primary care. The aim is to collect and study longitudinal data on pain and activity level through text-messages to investigate the trajectory of pain in relation to outcome and prognostic factors. This study forms the base for aim 3.
  3. Based on analyses from the cohort study in aim 2 aim conduct an randomized controlled trial (RCT) designed to target treatment for sub groups of LBP with a poor outcome following guideline recommended care. The RCT will be a two armed study with a tailored intervention compared to guideline recommended care for those with a poor outcome.

The cohort study and the RCT are planned to be conducted as a national multicentre study including primary health care settings all over Sweden. The cohort study may be considered a feasibility study in order to form the base for a primary health care registry on LBP.

The cohort study and the RCT are planned to be conducted as a national multicenter study including primary health care settings all over Sweden. The cohort study may be considered a feasibility study in order to form the base for a primary health care registry on LBP.

Specific hypotheses

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
16 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Males and females above 16 years of age reporting pain of at least 2/10 on a Numeric Pain Rating Scale (NPRS) sufficient to cause them to modify their activities of daily living, and seeking care for LBP, ability to read and speak the Swedish language.

排除标准

  • Participants are excluded if they have serious spinal pathology (i.e. fracture, metastatic disease), neurological disorders, severe spinal structural deformity, previous lower back surgery, pregnancy or other diagnoses that would require modification of the examination.

结局指标

主要结局

Pain level

时间窗: Change from baseline to 6 months and to 12 months

Self-assessed pain for the last 24 hours on NRS Numeric Rating Scale (0-10) . A successful outcome will be defines as \>2 measured on NRS. This cut off was previously used in a smaller study of prognosis following an exercise intervention

Disability

时间窗: Change from baseline to 6 months and to 12 months

Disability will be measured using Oswestry Disability Questionnaire (0-100). A successful outcome will be defines as \>20 measured on ODI. This cut off was previously used in a smaller study of prognosis following an exercise intervention

次要结局

  • Fear Avoidance Behavior(Change from baseline to 6 months and to 12 months)
  • Satisfaction with treatment and with outcome(Measured at 8 weeks and at 12 months)
  • Generic health-related quality of life(Change from baseline to 6 months and to 12 months)
  • Self-efficacy in relation to activity(Change from baseline to 6 months and to 12 months)
  • Expectation with treatment(Measured at baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eva Rasmussen Barr

Associate professor

Karolinska Institutet

研究点 (1)

Loading locations...

相似试验