NCT06278467

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2024

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 26, 2024

Completed
Last Updated

February 26, 2024

Status Verified

February 1, 2024

Enrollment Period

1.8 years

First QC Date

February 5, 2024

Last Update Submit

February 19, 2024

Conditions

Cognitive DysfunctionLow Back Pain

Keywords

cognitive dysfunctionlow back painChronic pain

Outcome Measures

Primary Outcomes (8)

  • 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

Study Arms (2)

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),Diagnostic Test: Pain catastrophizing scale, sleep quality with a single Likert type question in the Pittsburgh questionnaireDiagnostic 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)

Healtyh control

Healthy control with compatible sociodemographic characteristics (n=50)

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 questionnaireDiagnostic 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)

Interventions

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

VAS (0-10)

Healtyh controlPatients with chronic low back pain
Pain catastrophizing scale, sleep quality with a single Likert type question in the Pittsburgh questionnaireDIAGNOSTIC_TEST

PCS (Pain catastrophizing scale); sleep quality with a single Likert type question in the Pittsburgh questionnaire (0-3)

Healtyh controlPatients with chronic low back pain
Roland Morris Disability Questionnaire, quality of life with Short Form-36 ( SF-36),DIAGNOSTIC_TEST

functional disability level with Roland Morris Disability Questionnaire, quality of life with Short Form-36 ( SF-36)

Healtyh controlPatients with chronic low back pain
Montreal Cognitive Assessment Scale (MOCA); Standard Mini mental test (SMMT)DIAGNOSTIC_TEST

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

Healtyh controlPatients with chronic low back pain

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Konya Beyhekim Training and Research Hospital

Konya, Selçuklu, 42060, Turkey (Türkiye)

Location

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

Konya, 42060, Turkey (Türkiye)

Location

Related 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.

    PMID: 23707355BACKGROUND

  • 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.

    PMID: 33945940BACKGROUND

MeSH Terms

Conditions

Cognitive DysfunctionLow Back PainChronic Pain

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBack PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist Prof (MD)

Study Record Dates

First Submitted

February 5, 2024

First Posted

February 26, 2024

Study Start

March 1, 2022

Primary Completion

December 15, 2023

Study Completion

February 12, 2024

Last Updated

February 26, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(2)