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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06278467
Other study ID # KonyaBeyhekimTRH2023
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2022
Est. completion date February 12, 2024

Study information

Verified date February 2024
Source Konya Beyhekim Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 107
Est. completion date February 12, 2024
Est. primary completion date December 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 85 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
visual pain scale (VASpain/fatigue), Beck depression index (BDI),
VAS (0-10)
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)
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)
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)

Locations

Country Name City State
Turkey Konya Beyhekim Training and Research Hospital Konya Selçuklu
Turkey University of Health Sciences, Konya Beyhekim Training and Research Hospital, Department of Physical Medicine and Rehabilitation Konya

Sponsors (1)

Lead Sponsor Collaborator
Konya Beyhekim Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Montreal Cognitive Assessment Scale (MOCA) minimum and maximum values: 0 - 30, and higher scores mean a better outcome. 2022-2024
Primary Standard Mini mental test (SMMT) minimum and maximum values: 0 -30, and higher scores mean a better outcome. 2022-2024
Primary Short Form-36 ( SF-36) minimum and maximum values: 0 -100, and higher scores mean a better outcome. 2022-2024
Primary Beck depression scale (BDI) minimum and maximum values: 0 -63, and higher scores mean a worse outcome. 2022-2024
Primary Roland Morris Disability Questionnaire minimum and maximum values: 0 - 24, and higher scores mean a worse outcome 2022-2024
Primary 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
Primary VAS pain and VAS fatigue VAS minimum and maximum values: 0 - 10, and higher scores mean a worse outcome 2022-2024
Primary Pain catastrophizing scale minimum and maximum values: 0 - 52, and higher scores mean a worse outcome 2022-2024
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