- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05997368
Investigation of the Relationship of Pain Perception and Pain Belief With Age in People With Chronic Lack Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Istanbul, Turkey
- Üsküdar Unıversıty
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- having low back pain for at least the past three months
- be between the ages of 18-79.
Exclusion Criteria:
- Those outside the age limit of 18-79 and illiteracy.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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young group
Participants aged 18-39
|
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
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middle-aged group
Participants aged 40-56
|
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
|
|
elderly group
Participants aged 57-79
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The numeric rating scale - NRS-11
Time Frame: 2 weeks
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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).
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2 weeks
|
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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.
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2 weeks
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The pain beliefs questionnaire - PBQ
Time Frame: 2 weeks
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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. |
2 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Mahsun EKİNCİ, Uskudar university
Publications and helpful links
General Publications
- Walsh 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.
- Wandner 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.
- 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.
- Baird 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.
- Pulvers 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Uskudar67
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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