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临床试验/NCT05638997
NCT05638997已完成不适用

Effects of Different Treatment Methods Applied to Spine in Chronic Non-Spesific Low Back Pain: A Randomized Controlled Trial

Tokat Gaziosmanpasa University2 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2019年8月1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
51
试验地点
2
主要终点
Change from baseline visual analogue scale at 2nd and 6th weeks

研究概览

简要总结

We aimed to investigate the effects of instrument assisted manipulation (IAM) and Mulligan mobilization with movement (MWM) on joint range of motion (ROM), pain, proprioception, endurance, back awareness and disability in individuals with chronic non-specific low back pain (CNSLBP). Fifthy one participants were randomly divided into 3 groups. The first was the Mulligan group, the second was the IAM group, and the third was the core exercise group. Visual Analogue Scale (VAS) was used to assess pain severity. Lumbal flexibility was evaluated with the fingertip-to-floor test. Oswestry disability index (ODI) and Roland Morris Disability Questionnaire (RMDQ) used to evaluate the disability. Fremantle back awareness questionnaire (FBAQ) used to evaluate back awareness. Joint ROM (lumbal flexion, lumbal extension and lumbal lateral flexion) and proprioception (30° lumbal flexion in standing, 30° lumbal flexion in sitting, 15° lumbal extension standing and lumbal neutral position) evaluated with JTECH digital dual inclinometer. McGill core endurance tests were used for core endurance assessment. McGill core endurance assessment consists of 3 tests. These: Flexor endurance test, lateral endurance test and extensor endurance test.

详细描述

IAM and Mulligan MWM interventions were applied 3 days a week for 2 weeks in total 6 sessions. All 3 groups did same core exercise program. The exercise program was done from the baseline for 6 weeks, 3 days a week, for a total of 18 sessions. Outcome measurements were done at baseline, at the end of the 2nd week, and at the end of the 6th week. The researcher who performed the outcome measurements did not know the participant's group. Assessment and treatment were performed by two different researchers with 8 years of professional experience. Visual Analogue Scale (VAS) was used to assess pain severity. Lumbal flexibility was evaluated with the fingertip-to-floor test. Oswestry disability index (ODI) and Roland Morris Disability Questionnaire (RMDQ) used to evaluate the disability. Fremantle back awareness questionnaire (FBAQ) used to evaluate back awareness. Joint ROM (lumbal flexion, lumbal extension and lumbal lateral flexion) and proprioception (30° lumbal flexion in standing, 30° lumbal flexion in sitting, 15° lumbal extension standing and lumbal neutral position) evaluated with JTECH digital dual inclinometer. The measurement of the joint ROM in the lumbal region with the dual inclinometer technique is a reliable method. McGill core endurance tests were used for core endurance assessment. McGill core endurance assessment consists of 3 tests. These: Flexor endurance test, lateral endurance test and extensor endurance test.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • LBP for at least 3 months
  • Diagnosis of non-specific LBP
  • 20-55 ages.

排除标准

  • Red flag symptoms related to LBP
  • Neurological findings
  • Pain radiating to the leg
  • Undergone spinal surgery
  • Pathology of the spine (fracture, tumor, spondylolisthesis, spinal stenosis, cauda equina syndrome).

结局指标

主要结局

Change from baseline visual analogue scale at 2nd and 6th weeks

时间窗: Baseline, 2nd week, 6th week

Pain assessment. The minimum score of the visual analogue scale is 0, and the maximum score is 10. Higher scores indicate worse outcome.

Change from baseline Roland Morris disability questionnaire at 2nd and 6th weeks

时间窗: Baseline, 2nd week, 6th week

Disability assessment. The minimum score of the Roland Morris disability questionnaire is 0, and the maximum score is 24. Higher scores indicate worse outcome.

Change from baseline fingertip-to-floor test at 2nd and 6th weeks

时间窗: Baseline, 2nd week, 6th week

Lumbal flexibility

Change from baseline joint ROM measurement with digital inclinometer at 2nd and 6th weeks

时间窗: Baseline, 2nd week, 6th week

Lumbal flexion, lumbal extension and lumbal lateral flexion

Change from baseline Fremantle back awareness questionnaire at 2nd and 6th weeks

时间窗: Baseline, 2nd week, 6th week

Back awareness assessment. The minimum score of the Fremantle back awareness questionnaire is 0, and the maximum score is 36. Higher scores indicate worse outcome.

Change from baseline proprioception measurement with digital inclinometer at 2nd and 6th weeks

时间窗: Baseline, 2nd week, 6th week

30° lumbal flexion in standing, 30° lumbal flexion in sitting, 15° lumbal extension standing and lumbal neutral position

Change from baseline Oswestry disability index at 2nd and 6th weeks

时间窗: Baseline, 2nd week, 6th week

Disability assessment. The minimum score of the Oswestry disability index is 0, and the maximum score is 50. Higher scores indicate worse outcome.

次要结局

未报告次要终点

研究者

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

Erkan Erol

Assistant Professor

Tokat Gaziosmanpasa University

研究点 (2)

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