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Frequency of Cognitive Dysfunction in Patients With Chronic Low Back Pain

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06278467
Enrollment
107
Registered
2024-02-26
Start date
2022-03-01
Completion date
2024-02-12
Last updated
2024-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Dysfunction, Low Back Pain

Keywords

cognitive dysfunction, low back pain, Chronic pain

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.

Interventions

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

VAS (0-10)

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

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

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

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

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

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

Sponsors

Konya Beyhekim Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
Yes

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.)

Design outcomes

Primary

MeasureTime frameDescription
Montreal Cognitive Assessment Scale (MOCA)2022-2024minimum and maximum values: 0 - 30, and higher scores mean a better outcome.
Standard Mini mental test (SMMT)2022-2024minimum and maximum values: 0 -30, and higher scores mean a better outcome.
Short Form-36 ( SF-36)2022-2024minimum and maximum values: 0 -100, and higher scores mean a better outcome.
Beck depression scale (BDI)2022-2024minimum and maximum values: 0 -63, and higher scores mean a worse outcome.
Roland Morris Disability Questionnaire2022-2024minimum and maximum values: 0 - 24, and higher scores mean a worse outcome
A single Likert type question in the Pittsburgh questionnaire (Sleep quality)2022-2024minimum and maximum values: 0 - 3, and higher scores mean a better outcome
VAS pain and VAS fatigue2022-2024VAS minimum and maximum values: 0 - 10, and higher scores mean a worse outcome
Pain catastrophizing scale2022-2024minimum and maximum values: 0 - 52, and higher scores mean a worse outcome

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026