Clinical trial NCT06278467: Frequency of Cognitive Dysfunction in Patients With Chronic Low Back Pain
Official title: Frequency of Cognitive Dysfunction and Related Factors in Patients With Chronic Low Back Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Dysfunction
Low Back Pain
Keywords: cognitive dysfunction
low back pain
Chronic pain
Lead sponsor: Konya Beyhekim Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-02-26
Enrollment: 107
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Montreal Cognitive Assessment Scale (MOCA)
timeFrame: 2022-2024
measure: Standard Mini mental test (SMMT)
timeFrame: 2022-2024
measure: Short Form-36 ( SF-36)
timeFrame: 2022-2024
measure: Beck depression scale (BDI)
timeFrame: 2022-2024
measure: Roland Morris Disability Questionnaire
timeFrame: 2022-2024
measure: A single Likert type question in the Pittsburgh questionnaire (Sleep quality)
timeFrame: 2022-2024
measure: VAS pain and VAS fatigue
timeFrame: 2022-2024
measure: Pain catastrophizing scale
timeFrame: 2022-2024
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Konya Beyhekim Training and Research Hospital
state: Selçuklu
city: Konya
country: Turkey
facility: University of Health Sciences, Konya Beyhekim Training and Research Hospital, Department of Physical Medicine and Rehabilitation
Study officials:
References:
citation: 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.
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.