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临床试验/NCT03673436
NCT03673436已完成不适用

Effect of Lumbar Spinal Fusion Predicted by Physiotherapists: A Prospective Cohort Study

Rigshospitalet, Denmark1 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2018年9月30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
202
试验地点
1
主要终点
Oswestry Disability Index

研究概览

简要总结

The main purpose of this study is to investigate if improvements in patient self-reported pain, symptoms, function and quality of life 12 months after Lumbar spinal fusion among patients that have good projected prognosis differ from those among patients with a poor projected prognosis.

The secondary purpose is to explore the underlying factors of the physiotherapists projected prognosis to identify objective and possible modifiable candidate prognostic factors for recovery.

详细描述

Background:

Over recent decades, an increasing number of patients with Chronic Low Back Pain (CLBP) undergo surgical lumbar spinal fusion (LSF). For many of the patients LSF is their last resort in the hope of a better life with less pain, disability and use of medication. Unfortunately, several reports show, that the pain level remains the same after LSF for many patients, and that consumption of medication remains unchanged in almost 50 % of the patients.

Knowing that characteristics such as maladaptive coping strategies, fear avoidance beliefs and pain catastrophizing seem to be predictive of worse outcome in pain, function and quality of life after surgery. It is important to assess how these individual factors in the postsurgical rehabilitation can be addressed.

The single physiotherapists have an essential role in mobilizing the LSF patient post-operatively. In clinical practice it is not enough for the physiotherapists to use their biomechanical understanding of LSF material and heeling processes, it is also essential to use a so-called "silent knowledge" of experience and personal interaction with the patient.

It remains unknown if this "silent knowledge" is a reliable predictor of the outcome of LSF surgery. If the physiotherapist can predict the outcome, it is important to explore which factors the physiotherapist rely their prognosis upon in order to identify objective and possible modifiable candidate prognostic factors for recovery.

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

  • Received primary LSF surgery for treatment of CLBP
  • Degenerative lumbar disease with or without lumbar spondylolisthesis grades 1 to 2
  • Fusion of a maximum of 3 adjacent vertebrae
  • Above 18 years of age
  • Competence in the Danish language
  • Has an email address

排除标准

  • Prior LSF surgery
  • Cognitive impairments that preclude reliable answers to patient reported outcome questionnaire

结局指标

主要结局

Oswestry Disability Index

时间窗: 1 year

Disability will be measured using the Oswestry Disability Index. ODI is a validated measure of condition-specific disability originally developed for patients with LBP. The ODI consists of ten items regarding pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling. For each item the patient chooses one of six answers, with 0 representing no difficulty in the activity and 5 representing maximal difficulty.

次要结局

  • Health outcome and quality of life(1 year)
  • Questionnaire regarding postoperative rehabilitation(1 year)
  • Patient reported movement capacity(1 year)
  • Back Pain(1 year)
  • Leg Pain(1 year)

研究者

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

Heidi Tegner

Clinical physiotherapy supervisor, PT, MScH

Rigshospitalet, Denmark

研究点 (1)

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