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临床试验/NCT04191317
NCT04191317已完成不适用

Pain Neuroscience Education and Gradual Exposure to Exercise in Factory Workers With Chronic Low Back Pain

Aveiro University1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2019年12月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
37
试验地点
1
主要终点
Pain intensity

研究概览

简要总结

This study aims to compare the effectiveness of a pain neuroscience education (PNE) based programe and gradual exposure to exercise versus pilates on disability levels associated with chronic low back pain in factory workers. There will be two arms each one receiving one type of intervention over 8 weeks.

详细描述

This will be a pilot randomized controlled and experimental study. There will be two groups, one group will receive an intervention strategy based in basic postural re-education exercises (Pilates) and self-management strategies, and the other group will perform a program based in pain neuroscience education and gradual exposure to exercise. Both interventions will be delivered in the physiotherapy office of a paper industry. Participants will be randomly allocated according to the work team they belong, to an intervention arm.

The inclusion criteria to participate in the study are: to have nonspecific low back pain lasting longer than three months, felt in the anatomic region below the costal margin and above the inferior gluteal folds, without referred leg pain and not related to any specific pathology such as lumbar fracture, ankylosing spondylitis, cauda equina syndrome, infection or tumour and not receiving treatment for low back pain. Participants will be excluded if during the physical examination they show altered sensorial signs indicative of radiculopathy; red flags such as weight loss without a particular cause, cancer diagnosis or sustained use of corticoids; presence of any rheumatic, neurologic or cardiorespiratory disease that prevent the practice of physical exercise.

Once inclusion criteria have been ascertained, participants will be assessed for sociodemographic and anthropometric data, pain, disability, knowledge of pain neurophysiology, pain catastrophizing, fear of movement, presence of a neuropathic component, workstation evaluation and global impression of change related to intervention.

The intervention will last for 8 weeks, during which participants will have 1 face-to-face session per week with a duration of approximately 60 minutes each. One group (Pilates group) will receive an intervention based on Pilates' and and postural education. The other group will have theoretical sessions of PNE and gradual exposure to exercise (PNE plus graded exposure group).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • to have nonspecific low back pain lasting longer than three months, felt in the anatomic region below the costal margin and above the inferior gluteal folds, without referred leg pain and not related to any specific pathology such as lumbar fracture, ankylosing spondylitis, cauda equina syndrome, infection or tumour;
  • not receiving treatment for low back pain.

排除标准

  • altered sensorial signs indicative of radiculopathy; red flags such as weight loss without a particular cause, cancer diagnosis or sustained use of corticoids;
  • presence of any rheumatic, neurologic or cardiorespiratory disease that prevent the practice of physical exercise.

结局指标

主要结局

Pain intensity

时间窗: 3 months follow up

Measured using the Numerical Rating Scale (NRS), a 11-point scale is a measure of pain in which patients rate their pain ranging from 0 (no pain) to 10 (worst pain imaginable)

次要结局

  • Disability(3 months follow up)
  • Pain phenotype(3 months follow up)
  • Pain catastrophizing(3 months follow up)
  • Fear avoidance behavior(3 months follow up)
  • Knowledge of pain neurophysiology(3 months follow up)
  • Patient Global Impression of Change(3 months follow up)

研究者

发起方
Aveiro University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anabela G Silva

Doctor

Aveiro University

研究点 (1)

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