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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04969458
Other study ID # 123456789
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 22, 2020
Est. completion date November 23, 2020

Study information

Verified date July 2021
Source Yeditepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date November 23, 2020
Est. primary completion date November 16, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
survey application
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)

Locations

Country Name City State
Turkey Yeditepe University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Yeditepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Graded Chronic Pain Scale 2.0 GCPS 2.0 measures multiple dimensions of pain in patients with chronic pain. 3 minutes
Primary 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. 5 minutes
Primary 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. 5 minutes
Primary Roland-Morris Disability Questionnaire (RMDQ) RMDQ is a sensitive tool that measures the loss of function and disability due to low back pain. 5 minutes
Secondary 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. 5 minutes
Secondary 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. 15 minutes
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