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临床试验/NCT04787094
NCT04787094已完成不适用

The Effect of Yoga and Stabilization Exercises on Pain, Functional Status, Metabolic Capacity and Sleep Quality in Individuals With Chronic Low Back Pain: A Randomized, Crossover Study.

Hacettepe University2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2021年2月15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
28
试验地点
2
主要终点
Pain Intensity

研究概览

简要总结

Although exercise has been shown to be effective in low back pain in the literature, there is no conclusion about which exercise is superior to the other. Although there are studies showing positive effects of spinal stabilization exercises and yoga approach on pain level, disability level and quality of life in patients with chronic low back pain, studies evaluating the effectiveness in many other aspects are insufficient. Therefore, this study aimed to investigate the effects of spinal stabilization and yoga exercises on pain, functional status, metabolic capacity, kinesophobia and sleep quality in patients with chronic low back pain.

研究设计

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

入排标准

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

入选标准

  • Chronic non-specific low back pain diagnosis
  • Having pain that persists for at least 12 weeks
  • 25-65 age range

排除标准

  • Scoliosis with a cobb angle of more than 20º
  • History of previous surgery for the lumbal region
  • Having an additional diagnosis such as spondylolisthesis, spinal stenosis, spondylolysis
  • Presence of neurological deficits
  • Metastatic state presence
  • Presence of neurological deficits due to diabetes
  • Presence of metabolic problems such as thyroid, hypertension, coronary artery disease
  • The presence of inflammatory problems involving the spine

结局指标

主要结局

Pain Intensity

时间窗: 15 minutes, through study completion, an average of 8 weeks, Change from pain intensity

Pain intensity of participants will be evaluated with visual analog scale (VAS). Paricipants asked to mark the intensity of pain on a 10 cm long line, explaining that the leftmost of the line does not have pain, that the pain increases while moving to the right, and that the pain is unbearable on the far right. VAS scored between 0-10 cm.

Disability Severity

时间窗: 5 minutes, through study completion, an average of 8 weeks, Change from disability

Patient's pain related functional status will be measured by Oswestry Disability Index. The scale is considered the 'gold standard' of low back functional outcome tools. This scale contain questions related to functional activities of pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and travelling. Interpretation of scale are 0% to 20% for minimal disability, 21% to 40% for moderate disability, 41 % to 60 % for severe disability 61% to 80 % for crippled and 81 % to 100 % Bed-bound. The Oswestry Disability Index is scored between 0-50 points. An increase in score indicates a poor result. Patient's back-related functional performance will be evaluated with Back Performance Scale. Each question is scored between 0 and 3. The total score recorded. The Back Performance Scale test is scored between 0-15 points. An increase in score indicates a poor result.

Funcitonal Performance

时间窗: 10 minutes, through study completion, an average of 8 weeks, Change from Functional status and performance

Patient's back-related functional performance will be evaluated with Back Performance Scale. Each question is scored between 0 and 3. The total score recorded. The Back Performance Scale test is scored between 0-15 points. An increase in score indicates a poor result.

次要结局

  • Metabolic Capacity(15 minutes, through study completion, an average of 8 weeks, Change from Baseline metabolic capacity.)
  • Deep muscle activation(5 minutes, through study completion, an average of 8 weeks, Change from deep muscle activation)
  • Kinesiophobia(5 minutes, through study completion, an average of 8 weeks, Change from kinesiophobia)
  • Sleep quality(5 minutes, through study completion, an average of 8 weeks, Change from Baseline sleep quality)

研究者

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

Ozlem Ulger

Professor, Physiotherapist

Hacettepe University

研究点 (2)

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