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临床试验/NCT05213845
NCT05213845终止不适用

Assessment of Spine Rehabilitation Program Using Spine Flexion and Extension Full Active Range of Motion for Patients With Chronic Low Back Pain : a Monocentric Prospective Cohort Study

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2022年2月17日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
6
试验地点
2
主要终点
Roland-Morris disability questionnaire

研究概览

简要总结

The main objective of this study is to assess efficacy of a spine rehabilitation program, using spine flexion and extension full active range of motion, on physical disability of patients with chronic low back pain.

详细描述

Secondary objectives

The other objectives of this study are to assess the impact of spine rehabiliation program using spine flexion and extension full active range of motion on :

  • pain intensity ;
  • kinesiophobia
  • active range of motion of lumbar flexion and lumbar extension

Conduct of research

After receiving the written consent of the study, participants will benefit from 5 sessions of spine flexion and extension full active range of motion exercises. The following tests and questionnaires will be performed before (baseline) and after (posttreatment) the 5 sessions :

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • Medical prescription for chronic low back pain rehabilitation
  • Evolution of low back pain for at least 3 months
  • No treatment or rehabilitation for low back pain performed within 12 months before enrollment
  • Written informed consent given

排除标准

  • Spinal fracture or previous spinal surgery
  • Cognitive impairments that prevent from understanding the rehabilitation exercises
  • Patient with insufficient understanding or expression in French
  • Non-mechanical pain : gradually worsening pain, present at rest and especially at night
  • Neurological symptom : deficit in the control of bladder and anal sphincters, motor weakness of lower limbs, Cauda equina syndrome
  • Pubis paresthesia (or perineum)
  • Severe trauma (such as fall from height, traffic accident)
  • Unexplained weight loss
  • History of cancer
  • Drug use or long-term use of corticosteroid
  • Spinal deformity
  • Altered general condition
  • Patient with signs of neurological impairment : positive Lasegue test (Straight Leg Raise Test) or positive Slump test, or DN4 questionnaire greater than or equal to 4
  • Patient suffering from a central or peripheral neurological pathology
  • Patient taking a level II (weak opiates) or III (morphine and related substances) analgesic treatment
  • Patient under guardianship, curatorship or legal protection

结局指标

主要结局

Roland-Morris disability questionnaire

时间窗: Posttreatment (2 months)

The Roland-Morris questionnaire is a 24-item self report questionnaire assessing physical disability, ranging from 0 (no disability) to 24 (severe disability).

次要结局

  • Fear Avoidance Beliefs Questionnaire (FABQ)(Posttreatment (2 months))
  • Active range of motion of lumbar flexion and lumbar extension(Posttreatment (2 months))
  • Pain intensity(Posttreatment (2 months))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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