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Clinical Trials/NCT06278467
NCT06278467
Completed
Not Applicable

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

Konya Beyhekim Training and Research Hospital2 sites in 1 country107 target enrollmentMarch 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cognitive Dysfunction
Sponsor
Konya Beyhekim Training and Research Hospital
Enrollment
107
Locations
2
Primary Endpoint
Montreal Cognitive Assessment Scale (MOCA)
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2022
End Date
February 12, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Konya Beyhekim Training and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Ramazan Yılmaz

Assist Prof (MD)

Konya Beyhekim Training and Research Hospital

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Montreal Cognitive Assessment Scale (MOCA)

Time Frame: 2022-2024

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

Standard Mini mental test (SMMT)

Time Frame: 2022-2024

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

VAS pain and VAS fatigue

Time Frame: 2022-2024

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

Pain catastrophizing scale

Time Frame: 2022-2024

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

Short Form-36 ( SF-36)

Time Frame: 2022-2024

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

Roland Morris Disability Questionnaire

Time Frame: 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)

Time Frame: 2022-2024

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

Beck depression scale (BDI)

Time Frame: 2022-2024

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

Study Sites (2)

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