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临床试验/NCT03852667
NCT03852667已完成不适用

The Effect of Secondary Prevention for Low Back Pain by Means of Pain Education and Exercise Therapy in Patients With Recurrent Low Back Pain

University Ghent2 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2019年9月29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
76
试验地点
2
主要终点
Quality of neuromuscular control by use of the lumbopelvic movement control test

研究概览

简要总结

This study investigates the effect of a secondary intervention program for low back pain in patients with recurrent low back pain. One third of the subject will receive no therapy, one third wil receive 2 sessions of pain neuroscience education (PNE) and one third will receive two sessions of PNE and 5 sessions of exercise therapy over 6 weeks.

详细描述

Participants:

60 individuals with recurrent non-specific LBP were recruited through advertisement in sport facilities, social media and among friends and family.

Testing:

The testing was performed before and after a six week period by three blinded 2nd master students of physiotherapy of University of Ghent. The pre and post testing were almost identical and lasted 1 hour, only for the first testing an anamnesis was conducted to evaluate inclusion and exclusion criteria. The identical parts were tests for motor control, muscle performance and psychosocial factors.

Intervention:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

The leading investigators, as well as the outcome assessors are masked and do not know to which arm the subjects are allocated to.

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

  • In remission during testing
  • recurrent low back pain (RLBP) >6months
  • 2 or more episodes in the past year
  • Pain flare of ≥24 hours, characterized by an increase of ≥2 on an Numeric Rating Scale (NRS) scale and/or ≥5 on the Roland Morris Disability Questionnaire
  • Followed by a pain-free episode of ≥1 month, characterized by a 0/10 on an NRS scale and/or <2 on the Roland Morris Disability Questionnaire
  • Non-specific RLBP (no cause for Low back pain (LBP); >3y post discus herniation)
  • 1 year or more post-natal

排除标准

  • Use of antidepressants or analgesics (except for NSAIDs or paracetamol), taken 2 weeks before the testing
  • Neurologic, respiratory, circulatory, or severe orthopedic diseases
  • Pregnancy
  • Specific LBP causes
  • A history of cognitive exercise therapy and/or specific motor control training
  • current treatment or new therapies starting <6 weeks before baseline assessment

结局指标

主要结局

Quality of neuromuscular control by use of the lumbopelvic movement control test

时间窗: 6 weeks

The neuromuscular control of the lumbar region is measured pre and post intervention. This test evaluates a repeated lumbopelvic movement on five categories; quality of the lumbopelvic motion, control of the adjacent areas, preference of motion direction, breathing, and the amount of good quality repetitions.

Quality of core movement control by use of the Luomajoki test battery

时间窗: 6 weeks

A core movement control test battery is performed pre and post intervention, to assess a possible movement control dysfunction of the low back. This test battery consists out of six tests: waiters bow, dorsal tilt of pelvis actively in upright standing, one leg stance, sitting knee extension test, quadruped position, prone lying active knee flexion.

Quality of proprioception of the core by use of the lumbopelvic position-reposition test

时间窗: 6 weeks

A lumbopelvic position-reposition test was performed pre and post intervention for measuring proprioceptive deficits in the core in the subjects. This repositioning test evaluates the participant's repositioning accuracy of the pelvis, low back and trunk after a dynamic task.

次要结局

  • Improvement of trunk strength by use of a hand held dynamometer(6 weeks)
  • Psychosocial factor "Roland Morris disability questionnaire"(6 weeks)
  • Psychosocial factor "Tampa scale of kinesiophobia"(6 weeks)
  • Psychosocial factor "Pain catastrophizing scale"(6 weeks)
  • Psychosocial factor "Pain disability index"(6 weeks)
  • Psychosocial factor "Multidimensional pain inventory"(6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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