Chronic PainNCT05997368
Investigation of the Relationship of Pain Perception and Pain Belief With Age in People With Chronic Lack Pain
An observational study of Chronic Pain and Low Back Pain, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to investigate the relationship between pain perceptions and pain beliefs of individuals in different age groups with chronic low back pain and symptom severity. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Chronic Pain, Low Back Pain
- What is being tested?
- Survey1, Survey2 and Survey3
- How many people
- 210 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 25 Sep 2023
- 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 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will take place in Istanbul, Turkey. Volunteers who accepted the voluntary consent form will be included in the study.
Who may be able to join
- having low back pain for at least the past three months
- be between the ages of 18-79.
Who cannot join
- Those outside the age limit of 18-79 and illiteracy.
Trial locations and contacts
1 site in 1 country.
About this study
This study was planned to investigate the relationship between pain perceptions and pain beliefs of individuals in different age groups with chronic low back pain and symptom severity.
Read the detailed description
The study will be conducted as an observational descriptive and cross-sectional research. Participants will be recruited after the purpose and content of the research are explained by the researchers, their written consent is read, and the volunteers who agree to be included in the study are given their written consent. The data collection process was carried out face-to-face and via a Google Forms survey over the internet, and will be conducted with the participants face-to-face and online. In the study; The pain beliefs questionnaire (PBQ), the centrality of pain scale (COPS) and the numerical rating scale (NRS-11) will be used.
- Conditions
- Chronic Pain, Low Back Pain
- Being tested
- Survey1, Survey2, Survey3
- Keywords
- pain perception, pain beliefs
- Medical subject headings
- Chronic Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey1Other
As a research, it was planned to be a quantitative research. Data collection will be conducted through online and face-to-face surveys. Scales and forms to be found and used in the research: The Pain Beliefs Questionnaire-PBQ, Numerical Rating Scale (NRS-11) and The Central Of Pain Scale-COPS. By handing out the paper format to the participants and uploading it to the Google Forms system online, it can be downloaded from mail, social media or mobile phone applications such as message, Mail, etc. They will be asked to participate in the study by accessing
Survey2Other
As a research, it was planned to be a quantitative research. Data collection will be conducted through online and face-to-face surveys. Scales and forms to be found and used in the research: The Pain Beliefs Questionnaire-PBQ, Numerical Rating Scale (NRS-11) and The Central Of Pain Scale-COPS. By handing out the paper format to the participants and uploading it to the Google Forms system online, it can be downloaded from mail, social media or mobile phone applications such as message, Mail, etc. They will be asked to participate in the study by accessing
Survey3Other
As a research, it was planned to be a quantitative research. Data collection will be conducted through online and face-to-face surveys. Scales and forms to be found and used in the research: The Pain Beliefs Questionnaire-PBQ, Numerical Rating Scale (NRS-11) and The Central Of Pain Scale-COPS. By handing out the paper format to the participants and uploading it to the Google Forms system online, it can be downloaded from mail, social media or mobile phone applications such as message, Mail, etc. They will be asked to participate in the study by accessing
| Study group | Role | What they receive |
|---|---|---|
| young group | Participants aged 18-39 Receives: Other: Survey1 | |
| middle-aged group | Participants aged 40-56 Receives: Other: Survey2 | |
| elderly group | Participants aged 57-79 Receives: Other: Survey3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The numeric rating scale - NRS-11
When using the NRS-11, patients are asked to rate their pain on a scale of 0 to 10; where using integers (11 integers including zero) 0 represents "no pain" and 10 represents "worst possible pain". Based on prior studies and clinical experience of use, pain screening scores NRS-11 scores as mild (1-3) are classified as moderate (4-6) or severe (7-10).
Measured: 2 weeks
The centrality of pain scale - COPS)
It is a short 10-item self-report scale designed to assess the centrality of pain. COPS scores are significantly correlated with the clinician's assessment of individual-reported pain severity, disability, mental health, quality of life, and how well the patient's pain is controlled. Each item is rated on a five-point Likert scale. It is a 10-item questionnaire (1: strongly disagree, 2: disagree, 3: neither agree nor disagree, 4: agree, 5: strongly agree). Items 2, 4 and 9 are evaluated in reverse. The resulting value is the sum of all item scores. Higher scores indicate more "central" pain. The highest possible score is 50 and the lowest possible score is 10.
Measured: 2 weeks
The pain beliefs questionnaire - PBQ
Two subtests of the test were created: the 8-item Organic Beliefs subtest and the 4-item Psychological Beliefs subtest. The item numbers of both subtests are listed as follows:
Organic Beliefs: items 1, 2, 3, 5, 7, 8, 10, 11, Psychological Beliefs: Items 4, 6, 9, 12. The test takers are asked to indicate the most appropriate one for the participants from 6 options ranging from 1st "never" to 6th "always". The marked scores range from 1 to 6 for each item. The score collected for each subtest is calculated by taking the items in that subtest and summing them up and dividing the numbers by the number of items related to that subtest. An increase in the value calculated from the sub-dimension of the scale indicates that the belief in pain belonging to the sub-dimension is high, and a decrease in the value indicates low pain belief in the sub-dimension.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start1 Sep 2023
- Primary completion2 Sep 2023
- Study completion25 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Öğr. Üyesi Ömer Şevgin, Uskudar University
- Investigators
- Mahsun EKİNCİ, Study chair, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05997368
- Sponsor's protocol ID
- Uskudar67
- Status last verified
- Sep 2023
- First submitted
- 9 Aug 2023
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
La Touche R, Grande-Alonso M, Arnes-Prieto P, Paris-Alemany A. How Does Self-Efficacy Influence Pain Perception, Postural Stability and Range of Motion in Individuals with Chronic Low Back Pain? Pain Physician. 2019 Jan;22(1):E1-E13.
PubMed 30700075Baird AJ, Haslam RA. Exploring differences in pain beliefs within and between a large nonclinical (workplace) population and a clinical (chronic low back pain) population using the pain beliefs questionnaire. Phys Ther. 2013 Dec;93(12):1615-24. doi: 10.2522/ptj.20120429. Epub 2013 Jul 25.
PubMed 23886843Pulvers K, Hood A. The role of positive traits and pain catastrophizing in pain perception. Curr Pain Headache Rep. 2013 May;17(5):330. doi: 10.1007/s11916-013-0330-2.
PubMed 23512722Walsh DA, Radcliffe JC. Pain beliefs and perceived physical disability of patients with chronic low back pain. Pain. 2002 May;97(1-2):23-31. doi: 10.1016/s0304-3959(01)00426-2.
PubMed 12031776Wandner LD, Scipio CD, Hirsh AT, Torres CA, Robinson ME. The perception of pain in others: how gender, race, and age influence pain expectations. J Pain. 2012 Mar;13(3):220-7. doi: 10.1016/j.jpain.2011.10.014. Epub 2012 Jan 5.
PubMed 22225969
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship of Pain Perception and Pain Belief With Age in People With Chronic Lack Pain
- ClinicalTrials.gov ID
- NCT05997368
- Acronym / sponsor ID
- Uskudar67
- Conditions
- Chronic Pain, Low Back Pain
- Keywords
- pain perception, pain beliefs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 2 Sep 2023 (actual)
- Study completion
- 25 Sep 2023 (actual)
- First posted
- 18 Aug 2023 (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 was planned to investigate the relationship between pain perceptions and pain beliefs of individuals in different age groups with chronic low back pain and symptom severity.
Detailed description
The study will be conducted as an observational descriptive and cross-sectional research. Participants will be recruited after the purpose and content of the research are explained by the researchers, their written consent is read, and the volunteers who agree to be included in the study are given their written consent. The data collection process was carried out face-to-face and via a Google Forms survey over the internet, and will be conducted with the participants face-to-face and online. In the study; The pain beliefs questionnaire (PBQ), the centrality of pain scale (COPS) and the numerical rating scale (NRS-11) will be used.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| young group | – | Other: Survey1Participants aged 18-39 |
| middle-aged group | – | Other: Survey2Participants aged 40-56 |
| elderly group | – | Other: Survey3Participants aged 57-79 |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will take place in Istanbul, Turkey. Volunteers who accepted the voluntary consent form will be included in the study.
Key inclusion criteria (2 listed)
- having low back pain for at least the past three months
- be between the ages of 18-79.
Key exclusion criteria (1 listed)
- Those outside the age limit of 18-79 and illiteracy.
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 |
|---|---|---|
| Survey1As a research, it was planned to be a quantitative research. Data collection will be conducted through online and face-to-face surveys. Scales and forms to be found and used in the research: The Pain Beliefs Questionnaire-PBQ, Numerical Rating Scale (NRS-11) and The Central Of Pain Scale-COPS. By handing out the paper format to the participants and uploading it to the Google Forms system online, it can be downloaded from mail, social media or mobile phone applications such as message, Mail, etc. They will be asked to participate in the study by accessing | Other | young group |
| Survey2As a research, it was planned to be a quantitative research. Data collection will be conducted through online and face-to-face surveys. Scales and forms to be found and used in the research: The Pain Beliefs Questionnaire-PBQ, Numerical Rating Scale (NRS-11) and The Central Of Pain Scale-COPS. By handing out the paper format to the participants and uploading it to the Google Forms system online, it can be downloaded from mail, social media or mobile phone applications such as message, Mail, etc. They will be asked to participate in the study by accessing | Other | middle-aged group |
| Survey3As a research, it was planned to be a quantitative research. Data collection will be conducted through online and face-to-face surveys. Scales and forms to be found and used in the research: The Pain Beliefs Questionnaire-PBQ, Numerical Rating Scale (NRS-11) and The Central Of Pain Scale-COPS. By handing out the paper format to the participants and uploading it to the Google Forms system online, it can be downloaded from mail, social media or mobile phone applications such as message, Mail, etc. They will be asked to participate in the study by accessing | Other | elderly group |
Primary outcome
The numeric rating scale - NRS-11
Time frame: 2 weeks
When using the NRS-11, patients are asked to rate their pain on a scale of 0 to 10; where using integers (11 integers including zero) 0 represents "no pain" and 10 represents "worst possible pain". Based on prior studies and clinical experience of use, pain screening scores NRS-11 scores as mild (1-3) are classified as moderate (4-6) or severe (7-10).
The centrality of pain scale - COPS)
Time frame: 2 weeks
It is a short 10-item self-report scale designed to assess the centrality of pain. COPS scores are significantly correlated with the clinician's assessment of individual-reported pain severity, disability, mental health, quality of life, and how well the patient's pain is controlled. Each item is rated on a five-point Likert scale. It is a 10-item questionnaire (1: strongly disagree, 2: disagree, 3: neither agree nor disagree, 4: agree, 5: strongly agree). Items 2, 4 and 9 are evaluated in reverse. The resulting value is the sum of all item scores. Higher scores indicate more "central" pain. The highest possible score is 50 and the lowest possible score is 10.
The pain beliefs questionnaire - PBQ
Time frame: 2 weeks
Two subtests of the test were created: the 8-item Organic Beliefs subtest and the 4-item Psychological Beliefs subtest. The item numbers of both subtests are listed as follows: Organic Beliefs: items 1, 2, 3, 5, 7, 8, 10, 11, Psychological Beliefs: Items 4, 6, 9, 12. The test takers are asked to indicate the most appropriate one for the participants from 6 options ranging from 1st "never" to 6th "always". The marked scores range from 1 to 6 for each item. The score collected for each subtest is calculated by taking the items in that subtest and summing them up and dividing the numbers by the number of items related to that subtest. An increase in the value calculated from the sub-dimension of the scale indicates that the belief in pain belonging to the sub-dimension is high, and a decrease in the value indicates low pain belief in the sub-dimension.
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 2 Oct 2023.
- Background: PubMed 30700075La Touche R, Grande-Alonso M, Arnes-Prieto P, Paris-Alemany A. How Does Self-Efficacy Influence Pain Perception, Postural Stability and Range of Motion in Individuals with Chronic Low Back Pain? Pain Physician. 2019 Jan;22(1):E1-E13.
- Background: PubMed 23886843Baird AJ, Haslam RA. Exploring differences in pain beliefs within and between a large nonclinical (workplace) population and a clinical (chronic low back pain) population using the pain beliefs questionnaire. Phys Ther. 2013 Dec;93(12):1615-24. doi: 10.2522/ptj.20120429. Epub 2013 Jul 25.
- Background: PubMed 23512722Pulvers K, Hood A. The role of positive traits and pain catastrophizing in pain perception. Curr Pain Headache Rep. 2013 May;17(5):330. doi: 10.1007/s11916-013-0330-2.
- Background: PubMed 12031776Walsh DA, Radcliffe JC. Pain beliefs and perceived physical disability of patients with chronic low back pain. Pain. 2002 May;97(1-2):23-31. doi: 10.1016/s0304-3959(01)00426-2.
- Background: PubMed 22225969Wandner LD, Scipio CD, Hirsh AT, Torres CA, Robinson ME. The perception of pain in others: how gender, race, and age influence pain expectations. J Pain. 2012 Mar;13(3):220-7. doi: 10.1016/j.jpain.2011.10.014. Epub 2012 Jan 5.
- 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.
Mahsun EKİNCİ study chair
Uskudar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Low Back Pain, run by Uskudar University at 1 site 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 2 inclusion and 1 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 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The numeric rating scale - NRS-11 (time frame: 2 weeks). The study lists 3 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 NCT05997368, which also lists 5 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 2 Oct 2023.