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Completed

NCT Number: NCT06278467

Frequency of Cognitive Dysfunction in Patients With Chronic Low Back Pain

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

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Key information

Conditions

Cognitive Dysfunction Back Pain Chronic Pain Cognition Disorders Low Back Pain Mental Disorders Neurocognitive Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Konya Beyhekim Training and Research Hospital, Konya, Selçuklu, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • 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.)

Treatment and study plan

visual pain scale (VASpain/fatigue), Beck depression index (BDI),

Diagnostic Test

VAS (0-10)

Pain catastrophizing scale, sleep quality with a single Likert type question in the Pittsburgh questionnaire

Diagnostic Test

PCS (Pain catastrophizing scale); sleep quality with a single Likert type question in the Pittsburgh questionnaire (0-3)

Roland Morris Disability Questionnaire, quality of life with Short Form-36 ( SF-36),

Diagnostic Test

functional disability level with Roland Morris Disability Questionnaire, quality of life with Short Form-36 ( SF-36)

Montreal Cognitive Assessment Scale (MOCA); Standard Mini mental test (SMMT)

Diagnostic Test

cognitive status was measured by Montreal Cognitive Assessment Scale (MOCA) and Standard Mini mental test (SMMT)

Primary outcomes

  1. Montreal Cognitive Assessment Scale (MOCA)

    Time frame: 2022-2024

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

  2. Standard Mini mental test (SMMT)

    Time frame: 2022-2024

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

  3. Short Form-36 ( SF-36)

    Time frame: 2022-2024

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

  4. Beck depression scale (BDI)

    Time frame: 2022-2024

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

  5. Roland Morris Disability Questionnaire

    Time frame: 2022-2024

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

  6. 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

  7. VAS pain and VAS fatigue

    Time frame: 2022-2024

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

  8. Pain catastrophizing scale

    Time frame: 2022-2024

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

Sponsors and collaborators

Lead sponsor

Konya Beyhekim Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Feb 26, 2024
Registry last updated
Feb 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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