- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04969458
Reliability and Validity of the Turkish Version of the GCPS 2.0.(Graded Chronic Pain Scale 2.0) (GCPS)
July 13, 2021 updated by: Yeditepe University
Reliability and Validity of the Turkish Version of the Graded Chronic Pain Scale 2.0
This study was designed to conduct Turkish adaptation, cross-cultural adaptation, validity, and reliability study of Graded Chronic Pain Scale 2.0 in order to use it for Turkish people with Chronic Pain.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The GCPS 2.0 is an eight-item scale that evaluates the severity of chronic pain, the presence of persistent pain due to pain days, and the degree of disability due to pain.
It is easy, simple, useful and multidimensional.
80 volunteer participants who had chronic low back pain were studied.The data collection tools used in this study were; Clinic and Demographic Evaluation Form, Oswestry Low Back Pain Disability Index, Patterns of Activity Measure Pain, Roland-Morris Disability Questionnaire, Hospital Anxiety, and Depression Scale, and Graded Chronic Pain Scale 2.0.
In this study, the forms were sent by e-mail.
The Snowball sampling method was used in the data collection process.The stages of the Beaton Protocol were followed in the translation of the scale.
Validity was evaluated with the Face, Content, and Construct validity analyses.
Exploratory and confirmatory factor analyses were applied to determine the construct validity of the Turkish version of the scale.
Reliability was evaluated with the test-retest method, the parallel forms method, and the internal consistency.
Ten days after completing the scale, 30 participants filled out the scale again for the Test-retest method.
One of the scales we used for the parallel forms method was RMDQ and the other was ODI.
Study Type
Observational
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Istanbul, Turkey, 34755
- Yeditepe University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 66 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adult, Older Adult
Description
Inclusion Criteria:
Participants were Turkish speakers and volunteer participants aged 18 years and over and under 70 years of age who had recurrent or persistent chronic LBP for 6 months or more.The following participants with CLBP diagnosed by a physician were included in the study. These;
- Disc herniations
- Mechanical back pain
- Lumbar strain
- Spondylolisthesis
- Degenerative disc disease
- Muscle imbalance
- Lumbago
- A trigger point in the back muscles
Exclusion Criteria:
- Having a history of illness such as Psychiatric disorder, Cognitive impairment, Dementia, or Alzheimer's
- Low back pain that needs immediate treatment (neoplasm, cauda equina syndrome, infection, fracture)
- Inflammatory low back pain
- Low back pain due to a vascular cause
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
participants
The study included individuals whose native language is Turkish, who are over the age of 18 and under the age 70, diagnosed with chronic low back pain, without Psychiatric disorder, Cognitive impairment, Dementia, or Alzheimer's and who want to participate in the study.
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Data collection tools used in the study;
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Graded Chronic Pain Scale 2.0
Time Frame: 3 minutes
|
GCPS 2.0 measures multiple dimensions of pain in patients with chronic pain.
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3 minutes
|
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Clinic and Demographic Evaluation Form
Time Frame: 5 minutes
|
n the clinical section, there are questions the inclusion and exclusion criteria.
According to this section, the patient is included in the study.
In the demographic section, there is the section where the patient's demographic variables are collected.
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5 minutes
|
|
Oswestry Low Back Pain Disability Index (ODI)
Time Frame: 5 minutes
|
ODI is a questionnaire measuring the effect of low back pain on daily life and the level of disability caused by this pain.
|
5 minutes
|
|
Roland-Morris Disability Questionnaire (RMDQ)
Time Frame: 5 minutes
|
RMDQ is a sensitive tool that measures the loss of function and disability due to low back pain.
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5 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hospital Anxiety and Depression Scale (HADS)
Time Frame: 5 minutes
|
The hospital anxiety and depression scale have two sub-scales: Anxiety and Depression.
7 single-digit questions in the scale measure anxiety, while 7 questions with two numbers measure depression.
|
5 minutes
|
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Patterns of Activity Measure Pain (POAM-P)
Time Frame: 15 minutes
|
Some established activity patterns reduce patients' quality of life with chronic pain, increase their pain, and limit their movement.
These are modified patterns such as Overdoing, Avoidance, Pacing.
POAM-P determines which of these patterns chronic pain patients use.
There are 10 questions in each subsection, also 30 questions in total.
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15 minutes
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 22, 2020
Primary Completion (Actual)
November 16, 2020
Study Completion (Actual)
November 23, 2020
Study Registration Dates
First Submitted
July 13, 2021
First Submitted That Met QC Criteria
July 13, 2021
First Posted (Actual)
July 20, 2021
Study Record Updates
Last Update Posted (Actual)
July 20, 2021
Last Update Submitted That Met QC Criteria
July 13, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 123456789 (Bandirma Onyedi Eylul University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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