跳至主要内容
临床试验/NCT03863808
NCT03863808已完成不适用

Effect of Cognitive Behavioral Therapy on Chronic Low Back Pain With Sensitization

Marwa Elsayed2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年11月2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
30
试验地点
2
主要终点
The Oswestry disability index

研究概览

简要总结

PURPOSE:

The main objectives of the study are:

  1. To find the efficacy of using cognitive behavioural therapy on chronic low back pain with central sensitization.
  2. To assist in planning an ideal physical therapy rehabilitation program for these patients.

BACKGROUND:

Recent research has shown that CLBP is a multifactorial disorder comprising psychosocial factors like pain catastrophization, fear avoidance and central sensitization. Central sensitization has been defined as "An amplification of neural signaling within the central nervous system that elicits pain hypersensitivity", and "increased responsiveness of nociceptive neurons in the central nervous system to their normal or subthreshold afferent input".

Maladaptive behavior, false beliefs and misinformation regarding the cause of the pain are all contributing factors to the chronicity of LBP.

Central sensitization has been attributed to cortical reorganization and amplification of the somatosensory representation of the back causing increased pain and further contributing to the maladaptive behavior and beliefs.

Cognitive behavioral treatment has been an important intervention for psychological disorders for decades and recently has gained a lot of interest as an intervention for chronic pain in general and CLBP in specific.

HYPOTHESES:

It will be hypothesized that: Cognitive behavioural therapy will have a significant effect on centrally sensitized pain intensity and disability.

RESEARCH QUESTION:" Does cognitive behavioral therapy have a significant effect on chronic low back pain with central sensitization"

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
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18-
  • Patient must have experienced low back pain for at least 3 months.
  • Patient must have a score above or equal 40 in the Central Sensitization Inventory (CSI) (Neblett R. C., 2013) (Neblett R, 2015) (Neblett H. M., 2016) (R. De Pauw, 2015) (Mayer TG N. R., 2012) .
  • Patient must have a score of 3 and above on the Numerical Pain Rating Scale.

排除标准

  • Patients were excluded if they had taken pain medications on the day of the assessment.
  • Patient who had serious spinal pathologies, such as fractures, tumors or inflammatory diseases, such as ankylosing spondylitis, narrowing of spinal canal and other conditions or severe cardiorespiratory diseases.
  • Uncontrolled mental health condition that prevents successful compliance.

结局指标

主要结局

The Oswestry disability index

时间窗: Upto 24 weeks of treatment

The Oswestry Disability Index (ODI) is one of the most commonly used outcome measures for individuals with low back pain (LBP) (Fairbank JC, 2000) .The ODI shows good construct validity; internal consistency is rated as acceptable; test-retest reliability and responsiveness have been shown to be high; and burden of administration is low. The ODI is a self-administered questionnaire that requires 5 minutes to complete and 1 minute to score.

次要结局

  • The fear avoidance beliefs questionnaire(Upto 24 weeks of treatment)

研究者

发起方
Marwa Elsayed
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Marwa Elsayed

Effect of Cognitive Behavioral Therapy on Chronic Low Back Pain with sensitization.

MTI University

研究点 (2)

Loading locations...

相似试验

Effect of Cognitive Behavioral Therapy on Chronic... | 临床试验