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

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

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Cognitive Dysfunction
• Intervention / Treatment: 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)

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 Type: Observational
• Enrollment (Actual): 107

Contacts and Locations

Study Locations

• Turkey
  • Konya, Turkey, 42060
    • University of Health Sciences, Konya Beyhekim Training and Research Hospital, Department of Physical Medicine and Rehabilitation
  • Selçuklu
    • Konya, Selçuklu, Turkey, 42060
      • Konya Beyhekim Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Those with chronic low back pain over the age of 60 and healthy controls. Patients were included in the study according to the inclusion and exclusion criteria and on a voluntary basis.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with chronic low back pain; 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 )	Diagnostic test: visual pain scale (VASpain/fatigue), Beck depression index (BDI),; VAS (0-10); Diagnostic test: Pain 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 test: Roland 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 test: Montreal 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)
Healtyh control; Healthy control with compatible sociodemographic characteristics (n=50)	Diagnostic test: visual pain scale (VASpain/fatigue), Beck depression index (BDI),; VAS (0-10); Diagnostic test: Pain 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 test: Roland 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 test: Montreal 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)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Konya Beyhekim Training and Research Hospital

Publications and helpful links

General Publications

• Berryman C, Stanton TR, Jane Bowering K, Tabor A, McFarlane A, Lorimer Moseley G. Evidence for working memory deficits in chronic pain: a systematic review and meta-analysis. Pain. 2013 Aug;154(8):1181-96. doi: 10.1016/j.pain.2013.03.002. Epub 2013 Mar 14.
• Corti EJ, Gasson N, Loftus AM. Cognitive profile and mild cognitive impairment in people with chronic lower back pain. Brain Cogn. 2021 Jul;151:105737. doi: 10.1016/j.bandc.2021.105737. Epub 2021 May 1.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): December 15, 2023
• Study Completion (Actual): February 12, 2024

Study Registration Dates

• First Submitted: February 5, 2024
• First Submitted That Met QC Criteria: February 19, 2024
• First Posted (Estimated): February 26, 2024

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: low back pain; Chronic pain; cognitive dysfunction
• Additional Relevant MeSH Terms: Mental Disorders; Pain; Neurologic Manifestations; Neurocognitive Disorders; Cognition Disorders; Back Pain; Low Back Pain; Cognitive Dysfunction
• Other Study ID Numbers: KonyaBeyhekimTRH2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No