Frequency of Cognitive Dysfunction in Patients With Chronic Low Back Pain

Completed

• Conditions: Cognitive Dysfunction; Low Back Pain
• Interventions: Diagnostic Test: visual pain scale (VASpain/fatigue), Beck depression index (BDI),; Diagnostic Test: Pain catastrophizing scale, sleep quality with a single Likert type question in the Pittsburgh questionnaire; Diagnostic Test: Roland Morris Disability Questionnaire, quality of life with Short Form-36 ( SF-36),; Diagnostic Test: Montreal Cognitive Assessment Scale (MOCA); Standard Mini mental test (SMMT)

• Registration Number: NCT06278467
• Lead Sponsor: Konya Beyhekim Training and Research Hospital

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.

Study Timeline

• Study Start: 2022-03-01
• Primary Completion: 2023-12-15
• Status Verified: 2024-02
• Study First Submitted: 2024-02-05
• Study Completion: 2024-02-12
• Study First Submitted QC: 2024-02-19
• Last Update Submitted: 2024-02-19
• Study First Posted: 2024-02-26
• Last Update Posted: 2024-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with chronic low back pain	visual pain scale (VASpain/fatigue), Beck depression index (BDI),	Consecutive patients over the age of 60, diagnosed with CBP, who have been suffering from low back pain for at least 6 months (n=57 )
Healtyh control	Pain catastrophizing scale, sleep quality with a single Likert type question in the Pittsburgh questionnaire	Healthy control with compatible sociodemographic characteristics (n=50)
Healtyh control	Montreal Cognitive Assessment Scale (MOCA); Standard Mini mental test (SMMT)	Healthy control with compatible sociodemographic characteristics (n=50)
Patients with chronic low back pain	Roland Morris Disability Questionnaire, quality of life with Short Form-36 ( SF-36),	Consecutive patients over the age of 60, diagnosed with CBP, who have been suffering from low back pain for at least 6 months (n=57 )
Patients with chronic low back pain	Montreal Cognitive Assessment Scale (MOCA); Standard Mini mental test (SMMT)	Consecutive patients over the age of 60, diagnosed with CBP, who have been suffering from low back pain for at least 6 months (n=57 )
Healtyh control	visual pain scale (VASpain/fatigue), Beck depression index (BDI),	Healthy control with compatible sociodemographic characteristics (n=50)
Healtyh control	Roland Morris Disability Questionnaire, quality of life with Short Form-36 ( SF-36),	Healthy control with compatible sociodemographic characteristics (n=50)
Patients with chronic low back pain	Pain catastrophizing scale, sleep quality with a single Likert type question in the Pittsburgh questionnaire	Consecutive patients over the age of 60, diagnosed with CBP, who have been suffering from low back pain for at least 6 months (n=57 )

Primary Outcome Measures

Name	Time	Method
Montreal Cognitive Assessment Scale (MOCA)	2022-2024	minimum and maximum values: 0 - 30, and higher scores mean a better outcome.
Standard Mini mental test (SMMT)	2022-2024	minimum and maximum values: 0 -30, and higher scores mean a better outcome.
VAS pain and VAS fatigue	2022-2024	VAS minimum and maximum values: 0 - 10, and higher scores mean a worse outcome
Pain catastrophizing scale	2022-2024	minimum and maximum values: 0 - 52, and higher scores mean a worse outcome
Short Form-36 ( SF-36)	2022-2024	minimum and maximum values: 0 -100, and higher scores mean a better outcome.
Roland Morris Disability Questionnaire	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)	2022-2024	minimum and maximum values: 0 - 3, and higher scores mean a better outcome
Beck depression scale (BDI)	2022-2024	minimum and maximum values: 0 -63, and higher scores mean a worse outcome.

Trial Locations

Locations (2)

University of Health Sciences, Konya Beyhekim Training and Research Hospital, Department of Physical Medicine and Rehabilitation; 🇹🇷 Konya, Turkey

Konya Beyhekim Training and Research Hospital; 🇹🇷 Konya, Selçuklu, Turkey