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临床试验/NCT06278467
NCT06278467已完成不适用

Frequency of Cognitive Dysfunction and Related Factors in Patients With Chronic Low Back Pain

Konya Beyhekim Training and Research Hospital2 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2022年3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
107
试验地点
2
主要终点
Montreal Cognitive Assessment Scale (MOCA)

研究概览

简要总结

This study evaluates cognitive dysfunction status and related factors in patients with chronic low back pain over the age of 60.

详细描述

The study was designed as prospective, cross-sectional and hospital-based. 55 consecutive patients over the age of 60, diagnosed with CBP, who have been suffering from low back pain for at least 6 months, and a similar number of healthy volunteers (control) in terms of age and gender, who applied to the Physical Medicine and Rehabilitation outpatient clinic of Konya Beyhekim Training and Research Hospital, will be included in the study. Patients will be included in this cross-sectional, survey-type research after their compliance with the inclusion criteria is meticulously determined as a result of anamnesis and physical examination.

Detailed histories of all participants will be taken and detailed physical examinations will be performed. Sociodemographic and clinical characteristics of the participants, such as age, gender, height, weight, educational status, marriage status, duration of illness, and employment status, will be recorded.

Patients will be asked some survey-type questions in a decent environment. Patients' pain and fatigue levels were measured by the visual pain scale (VAS), their emotional states by the Beck depression scale (BDI) and Pain catastrophizing scale, their functional disability level by the Roland Morris Disability Questionnaire, and their sleep quality by the single Likert type question in the Pittsburgh questionnaire. Quality of life will be evaluated with Short Form-36 (SF-36), and their cognitive status will be evaluated with Standard Mini mental test (SMMT) and Montreal cognitive assessment scale (MOCA).MOCA, mini mental test and mood tests are administered by a professional psychologist experienced in the application of these scales.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
60 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being over 60 years old Having a history of low back pain lasting more than 6 months and being diagnosed with CBP Having pain of at least 3 intensity according to VAS

排除标准

  • Those under 60 years of age
  • Those with neurological deficits
  • Those with inflammatory low back pain
  • Those with rheumatic diseases such as fibromyalgia, polymyalgia rheumatica, ankylosing spondylitis, rheumatoid arthritis
  • Having undergone surgery in the lumbar region within the last 6 months
  • Those with widespread pain, those with significant pain in another anatomical location (e.g. gonarthrosis)
  • Those who use drugs or substances (alcohol, drugs, etc.) that may cause cognitive impairment
  • Those with known neurological diseases such as cerebrovascular disease, MS, Parkinson's, dementia
  • Those with major psychiatric illness
  • Those with communication problems
  • Those who have started psychiatric medical treatment within the last three months
  • Those with significant hearing or vision problems
  • Those with a history of uncontrolled systemic disease (cardiovascular, pulmonary, hepatic, renal, hematological, endocrine, etc.)

结局指标

主要结局

Montreal Cognitive Assessment Scale (MOCA)

时间窗: 2022-2024

minimum and maximum values: 0 - 30, and higher scores mean a better outcome.

Standard Mini mental test (SMMT)

时间窗: 2022-2024

minimum and maximum values: 0 -30, and higher scores mean a better outcome.

VAS pain and VAS fatigue

时间窗: 2022-2024

VAS minimum and maximum values: 0 - 10, and higher scores mean a worse outcome

Pain catastrophizing scale

时间窗: 2022-2024

minimum and maximum values: 0 - 52, and higher scores mean a worse outcome

Short Form-36 ( SF-36)

时间窗: 2022-2024

minimum and maximum values: 0 -100, and higher scores mean a better outcome.

Roland Morris Disability Questionnaire

时间窗: 2022-2024

minimum and maximum values: 0 - 24, and higher scores mean a worse outcome

A single Likert type question in the Pittsburgh questionnaire (Sleep quality)

时间窗: 2022-2024

minimum and maximum values: 0 - 3, and higher scores mean a better outcome

Beck depression scale (BDI)

时间窗: 2022-2024

minimum and maximum values: 0 -63, and higher scores mean a worse outcome.

次要结局

未报告次要终点

研究者

发起方
Konya Beyhekim Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Ramazan Yılmaz

Assist Prof (MD)

Konya Beyhekim Training and Research Hospital

研究点 (2)

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