NCT04969458

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 22, 2020

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2020

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 20, 2021

Completed
Last Updated

July 20, 2021

Status Verified

July 1, 2021

Enrollment Period

25 days

First QC Date

July 13, 2021

Last Update Submit

July 13, 2021

Conditions

Keywords

Graded Chronic Pain ScaleChronic PainDisabilityChronic Low Back PainValidity and Reliability

Outcome Measures

Primary Outcomes (4)

  • Graded Chronic Pain Scale 2.0

    GCPS 2.0 measures multiple dimensions of pain in patients with chronic pain.

    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.

    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.

    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.

    5 minutes

Secondary Outcomes (2)

  • Hospital Anxiety and Depression Scale (HADS)

    5 minutes

  • Patterns of Activity Measure Pain (POAM-P)

    15 minutes

Study Arms (1)

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.

Other: survey application

Interventions

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)

participants

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult, Older Adult

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yeditepe University

Istanbul, 34755, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2021

First Posted

July 20, 2021

Study Start

October 22, 2020

Primary Completion

November 16, 2020

Study Completion

November 23, 2020

Last Updated

July 20, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations