Frequency of Cognitive Dysfunction in Patients With Chronic Low Back Pain

NCT ID: NCT06278467

Last Updated: 2024-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

107 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-01

Study Completion Date

2024-02-12

Brief Summary

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

Detailed Description

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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.

Conditions

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Cognitive Dysfunction Low Back Pain

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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 )

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

Intervention Type DIAGNOSTIC_TEST

VAS (0-10)

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

Intervention Type 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),

Intervention Type 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)

Intervention Type DIAGNOSTIC_TEST

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)

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

Intervention Type DIAGNOSTIC_TEST

VAS (0-10)

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

Intervention Type 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),

Intervention Type 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)

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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

VAS (0-10)

Intervention Type 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)

Intervention Type 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)

Intervention Type 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)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.)
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Konya Beyhekim Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Ramazan Yılmaz

Assist Prof (MD)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Konya Beyhekim Training and Research Hospital

Konya, Selçuklu, Turkey (Türkiye)

Site Status

University of Health Sciences, Konya Beyhekim Training and Research Hospital, Department of Physical Medicine and Rehabilitation

Konya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 23707355 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33945940 (View on PubMed)

Other Identifiers

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KonyaBeyhekimTRH2023

Identifier Type: -

Identifier Source: org_study_id

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