Chronic PainGCPSNCT04969458
Reliability and Validity of the Turkish Version of the GCPS 2.0.(Graded Chronic Pain Scale 2.0)
An observational study of Chronic Pain and Scale Reliability Validity, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Pain, Scale Reliability Validity
- What is being tested?
- survey application
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Oct 2020to 23 Nov 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult, Older Adult
Who may be able to join
- 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
Show all 9Show fewer
- Muscle imbalance
- Lumbago
- A trigger point in the back muscles
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Pain, Scale Reliability Validity
- Being tested
- survey application
- Keywords
- Graded Chronic Pain Scale, Chronic Pain, Disability, Chronic Low Back Pain, Validity and Reliability
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
survey applicationOther
Data collection tools used in the study;
- Clinic and Demographic Evaluation Form
- Oswestry Low Back Pain Disability Index (ODI)
- Patterns of Activity Measure Pain (POAM-P)
- Roland-Morris Disability Questionnaire (RMDQ)
- Hospital Anxiety and Depression Scale (HADS)
- Graded Chronic Pain Scale Version 2.0 (GCPS 2.0)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: survey application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graded Chronic Pain Scale 2.0
GCPS 2.0 measures multiple dimensions of pain in patients with chronic pain.
Measured: 3 minutes
Clinic and Demographic Evaluation Form
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.
Measured: 5 minutes
Oswestry Low Back Pain Disability Index (ODI)
ODI is a questionnaire measuring the effect of low back pain on daily life and the level of disability caused by this pain.
Measured: 5 minutes
Roland-Morris Disability Questionnaire (RMDQ)
RMDQ is a sensitive tool that measures the loss of function and disability due to low back pain.
Measured: 5 minutes
Secondary outcomes (2)
Hospital Anxiety and Depression Scale (HADS)
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.
Measured: 5 minutes
Patterns of Activity Measure Pain (POAM-P)
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.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start22 Oct 2020
- Primary completion16 Nov 2020
- Study completion23 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04969458
- Sponsor's protocol ID
- 123456789
- Acronym
- GCPS
- Status last verified
- Jul 2021
- First submitted
- 13 Jul 2021
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of the Turkish Version of the Graded Chronic Pain Scale 2.0
- ClinicalTrials.gov ID
- NCT04969458
- Acronym / sponsor ID
- GCPS / 123456789
- Conditions
- Chronic Pain, Scale Reliability Validity
- Keywords
- Graded Chronic Pain Scale, Chronic Pain, Disability, Chronic Low Back Pain, Validity and Reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- 22 Oct 2020 (actual)
- Primary completion
- 16 Nov 2020 (actual)
- Study completion
- 23 Nov 2020 (actual)
- First posted
- 20 Jul 2021 (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 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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| participants | – | Other: survey applicationThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult, Older Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| survey applicationData collection tools used in the study; * Clinic and Demographic Evaluation Form * Oswestry Low Back Pain Disability Index (ODI) * Patterns of Activity Measure Pain (POAM-P) * Roland-Morris Disability Questionnaire (RMDQ) * Hospital Anxiety and Depression Scale (HADS) * Graded Chronic Pain Scale Version 2.0 (GCPS 2.0) | Other | participants |
Primary outcome
Graded Chronic Pain Scale 2.0
Time frame: 3 minutes
GCPS 2.0 measures multiple dimensions of pain in patients with chronic pain.
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.
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.
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.
2 secondary outcomes
Hospital Anxiety and Depression Scale (HADS)
Time frame: 5 minutes
Patterns of Activity Measure Pain (POAM-P)
Time frame: 15 minutes
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 20 Jul 2021.
- 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.
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 Scale Reliability Validity, run by Yeditepe 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 9 inclusion and 4 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 20 Jul 2021. 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?
Graded Chronic Pain Scale 2.0 (time frame: 3 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2021.