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临床试验/NCT04938739
NCT04938739已完成不适用

Effect of Cognitive Behavioral Therapy in Patients With Chronic Nonspecific Low Back Pain

Cairo University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年12月1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
30
试验地点
2
主要终点
Assessing the change in pain intensity

研究概览

简要总结

The purpose of the study is to determine the effectiveness of cognitive-behavioral therapy on functional outcomes, pain, and pain-related anxiety in patients with chronic nonspecific low back pain

详细描述

Back pain has considerable negative effects on the quality of life of affected individuals. Individuals with new-onset back pain have an increased risk of lower quality of life scores, and the negative effect on quality of life increases with persistent pain. Patients with chronic back pain report a quality of life that is lower than individuals without pain and that is comparable to those of individuals with life-threatening diagnoses. In addition, back pain is associated with worry and fears, particularly about the (sense of) self and socialrelationships and especially when pain persists longer than expected.

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 (Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Thirty patients with non-specific chronic low back pain from both sexes will be included.
  • Subjects with normal body mass index (18 to 25).
  • The age of patients range from 20 to 35 years.
  • Duration of pain more than 3 months up to 2 years.
  • Normal cognition score 26 or above according to MoCA Scale.
  • Highly educated at least high school.

排除标准

  • The patients will be excluded if they have any of the followings:
  • Lumbar canal stenosis.
  • Lumbar discogenic lesions.
  • Any inflammatory arthritis, tumors, infection involving the lumbar spine.
  • Patients with decreased range of motion secondary to congenital anomalies, muscular contracture or bony block.
  • Previous lumbar surgery or trauma.
  • Subjects with a history of any neurologic disease.
  • Cauda equina Syndrome.
  • Patients suffering from psychological, cognitive or emotional disturbance.
  • Patients who had previously participated in cognitive behavioral therapy.
  • Deafness and blindness.

结局指标

主要结局

Assessing the change in pain intensity

时间窗: Baseline and 6 weeks post-intervention

Assessment via using visual analogue scale A tool used to help a person rate the intensity of certain sensations and feelings, such as pain. The visual analog scale for pain is a straight line with one

Assessing the change in back function

时间窗: Baseline and 6 weeks post-intervention

Assessment via using Oswestry Low Back Pain Disability Index It is a 10-item self assessing questionnaire; each item contains 6 levels of answers that can be scored from 0 to 5.

次要结局

  • Assessing the change in anxiety related to pain(Baseline and 6 weeks post-intervention)

研究者

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

Manar Abd El galil Aneis

Principal Investigator

Cairo University

研究点 (2)

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