Frequency of Cognitive Dysfunction in Patients With Chronic Low Back Pain

Low Back Pain Clinical Trial

Official title:

Frequency of Cognitive Dysfunction and Related Factors in Patients With Chronic Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06278467
• Other study ID #: KonyaBeyhekimTRH2023
• Status: Completed
• 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
• 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.)

Related Conditions & MeSH terms

• Back Pain
• Cognitive Dysfunction
• Low Back Pain

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