跳至主要内容
临床试验/CTRI/2025/03/083544
CTRI/2025/03/083544尚未招募不适用

Effect of pain science education on sleep quality, cognition and posture in patients with non-specific chronic low back pain. A pilot investigation.

Jamia Millia Islamia1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年4月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
24
试验地点
1
主要终点
PSQI

研究概览

简要总结

This study will be carried out at human performance laboratory and out patient department, centre for physiotherapy and Rehabilitation Sciences (CPRS), Jamia Millia Islamia. Subjects with Chronic low back painwill be recruited on the basis of inclusion and exclusion criteria and informedabout the study. Subject will be explained the purpose and the possible risksof the study. They will be given an informed consent explaining their rights asresearch subjects (According to Helsinki declaration,1964).Following the screening, demographics including age, height, weight, and BMI aswell as clinical characteristics such as Numeric pain rating scale, Oswestrydisability questionnaire, Mc gill pain quessionnaire, central sensitizationInventory, PSQI for sleep quality, the cognitive assessment will be done byusing Montreal Cognitive Assessment (MoCA) (subjective) and Event relatedpotential P300 (objective) will be assessed. Posture analysis will be done byusing Gait On posture analysis device. After assessing the baseline criterionmeasures, the participants will be further randomly allocated to one of thethree interventions groups: (I) Conventional treatment (Lumbarstabilization exercises, hot pack and  IFT) (II) Pain science education group(conventional treatment with pain science education).  The intervention will be given for 6 weeksperiod. The outcome variables will be assessed at baseline and after a periodof 6 weeks.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • 1.Medical diagnosis of non-specific chronic Low back pain (NCLBP) with pain and symptoms persisting for longer than 3 months
  • NPRS more than 3
  • Ambulation without a walking aid.
  • Subjects volunteering to participate in the study
  • Participants having a basic understanding of the English language.

排除标准

  • Unwilling or unable to complete the extensive physical examination.
  • Pregnant women
  • Any Lumbar surgery
  • Spinal deformities
  • Lower limb deformities
  • Severe hip degenerative disorders
  • Inflammatory joint disease
  • Traumatic low back and lower limb injuries
  • Osteoporosis
  • Spine and lower extremity fracture or dislocation
  • Any neurological or motor deficit
  • Known case of any serious medical pathology.

结局指标

主要结局

PSQI

时间窗: At baseline | At 6 weeks

Gait On posture analysis

时间窗: At baseline | At 6 weeks

P300-Event related potential

时间窗: At baseline | At 6 weeks

Oswestry disability questionnaire

时间窗: At baseline | At 6 weeks

次要结局

  • MOCA for cognition assessment(Tampa scale of kinesiophobia)

研究者

申办方类型
Contract research organization

研究点 (1)

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