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临床试验/NCT02645123
NCT02645123已完成不适用

Gait Analysis of Chronic Low Back Pain Patients Before and After the Application of Spinal Mobilization

University of Ioannina0 个研究点目标入组 75 人开始时间: 2011年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
75
主要终点
Change in the Numerical Pain Rating Scale

研究概览

简要总结

Introduction: patients with chronic back pain as a result of degenerated disc disease, besides pain also present with impaired gait. The purpose of this study is to evaluate both the clinical data using clinical rating scales, such as Oswestry Disability Index Greek version (ODI), Numerical Pain Rating Scale for low back pain and leg pain (NPRS) and the Roland Morris Disability Questionnaire Greek Version, and kinetic and kinematic characteristics during gait analysis in patients with chronic low back pain as a result of the degenerated disc disease (Disc Degenerative Disease), before and after application of manual therapy techniques.

Methodology: for the purposes of the study, 75 patients suffering from chronic low back pain were randomly divided into 3 groups of 25 each. Each group received five sessions with the first group receiving manual therapy treatment (spinal mobilisation), the second a sham treatment and the third, classic physiotherapy (stretching exercises, TENS and massage). To evaluate the effectiveness of each treatment, the visual analog pain scale, two questionnaires (Oswestry and Roland Morris) and also an optoelectronic system for recording and analysis of gait (kinetic and kinematic data) were utilized.

详细描述

This was a randomized controlled trial comparing the efficacy of spinal mobilization with other physiotherapy interventions (stretching, TENS application and Swedish type massage) and sham treatment in a group of chronic low back pain patients. The outcome measures included three dimensional gait analysis (kinetic and kinematic data) as well as clinical indicators (numerical pain rating scale, Oswestry disability index, Roland-Moris Disability questionnaire).

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
Single (Participant)

入排标准

年龄范围
21 Years 至 78 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • low back pain for over 3 months
  • recent lumbar MRI (up to 12 months)
  • able to walk without the need of walking aids

排除标准

  • leg length discrepancy of over 2 cm
  • history of spinal surgery
  • history of autoimmune disease
  • history of spondylolysis and spondylolisthesis
  • spinal fractures
  • pregnancy
  • respiratory and/or cardiac disease
  • history of stroke
  • hip, knee or ankle osteoarthritis
  • cauda equina syndrome
  • spinal inflammation
  • spinal tumor
  • steroid drug use in the last month
  • osteoporosis

结局指标

主要结局

Change in the Numerical Pain Rating Scale

时间窗: before the beginning, after the end of 5 weeks and 6 months after the last treatment session for each patient

this scale expresses the self rated pain levels in a 0 to 10 range with 0 meaning no pain and 10 the worst imaginable pain.

Change in the Oswestry Low Back Pain Disability Index

时间窗: before the beginning, after the end of 5 weeks for each patient and 6 months after the last treatment session for each patient

this is a self rated questionnaire that is expressed in a percentage with 0% meaning no disability and 100% meaning total disability. The minimum detectable change is reported to be 10% points

Change in the Roland-Morris Disability Questionnaire

时间窗: before the beginning, after the end of 5 weeks for each patient and 6 months after the last treatment session for each patient

The Roland-Morris Disability Questionnaire is designed to assess self-rated physical disability caused by low back pain. The Roland-Morris Disability Questionnaire is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. For patients with severe disability the Oswestry disability questionnaire is recommended. in this case, we used the 24 question version in which 0 means no disability and 24 means total disability.

Change in the 3 Dimensional Gait Characteristics (Kinetic and Kinematic) (Motion Analysis Optoelectronic Gait Analysis System Along With 2 Kistler Force Platforms)

时间窗: before the beginning and after the end of 5 weeks for each patient

The data was recorded using relevant software (Cortex, Calcium Solver, Skeleton Builder, DV Reference, Sky Scripting, KinTools RT). Κinetic and kinematic data were assessed and analysed at 3 different gait cycle time moments defined by the gait cycle and the amount of ground reaction force (GRF) during both left and right foot contact: moment 1 (T1) was at maximum GRF during heel strike, moment 2 (T2) at minimum GRF during mid stance, and moment 3 (T3) at maximum GRF during acceleration before toe off (http://www.oandplibrary.org/popup.asp?frmItemId=2A1E740F-13FD-4A68-B8A3-83A407795B5F\&frmType=image\&frmId=1). From these, we extrapolated the quotient (between R and L kinetic and kinematic data) values. A value of 1 would mean absolute symmetry between left and right side (Seliktar and Mizrahi, 1986). the participants walked for 10 times and the mean values of the best 3 measurements were used for analysis.

次要结局

未报告次要终点

研究者

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

Georgios Krekoukias

Physiotherapist MSc PhD MMACP

University of Ioannina

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