Cognitive DysfunctionNCT06278467
Frequency of Cognitive Dysfunction in Patients With Chronic Low Back Pain
An observational study of Cognitive Dysfunction and Low Back Pain, run by Konya Beyhekim Training and Research Hospital at 2 sites in Turkey (Türkiye).
Trial summary
This study evaluates cognitive dysfunction status and related factors in patients with chronic low back pain over the age of 60. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Dysfunction, Low Back Pain
- What is being tested?
- visual pain scale (VASpain/fatigue), Beck depression index (BDI),, Pain catastrophizing scale, sleep quality with a single Likert type question in the Pittsburgh questionnaire and Roland Morris Disability Questionnaire, quality of life with Short Form-36 ( SF-36),
- How many people
- 107 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Mar 2022to 12 Feb 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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.)
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Konya Beyhekim Training and Research Hospital
Konya, Selçuklu, 42060
University of Health Sciences, Konya Beyhekim Training and Research Hospital, Department of Physical Medicine and Rehabilitation
Konya, 42060
About this study
Official title: Frequency of Cognitive Dysfunction and Related Factors in Patients With Chronic Low Back Pain
This study evaluates cognitive dysfunction status and related factors in patients with chronic low back pain over the age of 60.
Read the 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.
- Conditions
- Cognitive Dysfunction, Low Back Pain
- Being tested
- visual pain scale (VASpain/fatigue), Beck depression index (BDI),, Pain catastrophizing scale, sleep quality with a single Likert type question in the Pittsburgh questionnaire, Roland Morris Disability Questionnaire, quality of life with Short Form-36 ( SF-36),, Montreal Cognitive Assessment Scale (MOCA); Standard Mini mental test (SMMT)
- Keywords
- cognitive dysfunction, low back pain, Chronic pain
- Medical subject headings
- Cognitive Dysfunction, Low Back Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
visual pain scale (VASpain/fatigue), Beck depression index (BDI),Diagnostic test
VAS (0-10)
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)
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)
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)
| Study group | Role | What they receive |
|---|---|---|
| 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 ) Receives: 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 questionnaire; Diagnostic 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) Receives: 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 questionnaire; Diagnostic 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment Scale (MOCA)
minimum and maximum values: 0 - 30, and higher scores mean a better outcome.
Measured: 2022-2024
Standard Mini mental test (SMMT)
minimum and maximum values: 0 -30, and higher scores mean a better outcome.
Measured: 2022-2024
Short Form-36 ( SF-36)
minimum and maximum values: 0 -100, and higher scores mean a better outcome.
Measured: 2022-2024
Beck depression scale (BDI)
minimum and maximum values: 0 -63, and higher scores mean a worse outcome.
Measured: 2022-2024
Roland Morris Disability Questionnaire
minimum and maximum values: 0 - 24, and higher scores mean a worse outcome
Measured: 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
Measured: 2022-2024
VAS pain and VAS fatigue
VAS minimum and maximum values: 0 - 10, and higher scores mean a worse outcome
Measured: 2022-2024
Pain catastrophizing scale
minimum and maximum values: 0 - 52, and higher scores mean a worse outcome
Measured: 2022-2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start1 Mar 2022
- Primary completion15 Dec 2023
- Study completion12 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cognitive DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 107 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Konya Beyhekim Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ramazan Yılmaz, Konya Beyhekim Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06278467
- Sponsor's protocol ID
- KonyaBeyhekimTRH2023
- Status last verified
- Feb 2024
- First submitted
- 5 Feb 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23707355Corti 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.
PubMed 33945940
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Cognitive Dysfunction and Related Factors in Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT06278467
- Acronym / sponsor ID
- KonyaBeyhekimTRH2023
- Conditions
- Cognitive Dysfunction, Low Back Pain
- Keywords
- cognitive dysfunction, low back pain, Chronic pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Konya Beyhekim Training and Research HospitalOther government
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 12 Feb 2024 (actual)
- First posted
- 26 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic low back pain | – | 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 questionnaire, Diagnostic 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)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 ) |
| Healtyh control | – | 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 questionnaire, Diagnostic 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)Healthy control with compatible sociodemographic characteristics (n=50) |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| visual pain scale (VASpain/fatigue), Beck depression index (BDI),VAS (0-10) | Diagnostic test | Healtyh control, Patients with chronic low back pain |
| Pain catastrophizing scale, sleep quality with a single Likert type question in the Pittsburgh questionnairePCS (Pain catastrophizing scale); sleep quality with a single Likert type question in the Pittsburgh questionnaire (0-3) | Diagnostic test | Healtyh control, Patients with chronic low back pain |
| 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) | Diagnostic test | Healtyh control, Patients with chronic low back pain |
| 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) | Diagnostic test | Healtyh control, Patients with chronic low back pain |
Primary outcome
Montreal Cognitive Assessment Scale (MOCA)
Time frame: 2022-2024
minimum and maximum values: 0 - 30, and higher scores mean a better outcome.
Standard Mini mental test (SMMT)
Time frame: 2022-2024
minimum and maximum values: 0 -30, and higher scores mean a better outcome.
Short Form-36 ( SF-36)
Time frame: 2022-2024
minimum and maximum values: 0 -100, and higher scores mean a better outcome.
Beck depression scale (BDI)
Time frame: 2022-2024
minimum and maximum values: 0 -63, and higher scores mean a worse outcome.
Roland Morris Disability Questionnaire
Time frame: 2022-2024
minimum and maximum values: 0 - 24, and higher scores mean a worse outcome
A single Likert type question in the Pittsburgh questionnaire (Sleep quality)
Time frame: 2022-2024
minimum and maximum values: 0 - 3, and higher scores mean a better outcome
VAS pain and VAS fatigue
Time frame: 2022-2024
VAS minimum and maximum values: 0 - 10, and higher scores mean a worse outcome
Pain catastrophizing scale
Time frame: 2022-2024
minimum and maximum values: 0 - 52, and higher scores mean a worse outcome
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Background: PubMed 23707355Berryman 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.
- Background: PubMed 33945940Corti 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Dysfunction and Low Back Pain, run by Konya Beyhekim Training and Research Hospital at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assessment Scale (MOCA) (time frame: 2022-2024). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06278467, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.