Translation, Cultural Adaptation, Reliability, and Validity of the Turkish Version of the Cervical Radiculopathy Impact Scale

May 1, 2021 updated by: Halime ARIKAN, Gazi University
The purpose of this study was to investigate adaptation, validity, and reliability of the Turkish version of the Cervical Radiculopathy Impact Scale (CRIS).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Cervical radicular syndrome is a common health problem that causes pain in the arm and / or hand and is accompanied by motor and / or sensory defects. These symptoms often have an intensity that prevents normal function. For individuals with cervical radicular syndrome, there is a lack of a patient-reported outcome measurement tool to measure the impact of the disorder. The Cervical Radiculopathy Impact Scale (CRIS), which focuses on the symptoms and functionality of the arm and neck, was developed to improve the quality of studies on cervical radicular syndrome. CRIS is a newly developed self-report questionnaire that covers the measurement of symptoms and limitations in individuals with cervical radiculopathy due to pain, tingling sensation, and loss of sensation in the arm with neck discomfort. The CRIS consists of 21 items divided into three subscales: (i) symptoms, (ii) energy and postures, and (iii) actions and activities. Each item contains a likert type answer and takes a value between 1 and 5. The study is planned with 105 individuals with hip disease. After questioning the sociodemographic characteristics of the individuals, the patients will be asked to fill in CRIS, EQ-5D Health-Related Quality of Life Questionnaire, Neck Disability Index, Quick Disabilities of the Arm Shoulder and Hand, Brief Illness Perception Questionnaire, Short Form-36 and Visual Analog Scale. Test-retest will be re-applied to those of the same individuals who can be reached after 1 week. The results will be analyzed using the SPSS version 22.0 computer package program.

Study Type

Observational

Enrollment (Anticipated)

105

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study population will consist of individuals with cervical radiculpathy symptoms, diagnosis, and chronic pain on cervical spine region.

Description

Inclusion Criteria:

  • Individuals with radiculopathy symptoms and diagnosis.

Exclusion Criteria:

  • Having another neck disorder other than radiculopathy,
  • History of cervical spine surgery,
  • Corticosteroid injection to cervical spine in the past 3 months,
  • Having neurological and cognitive disorders.

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: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients group
Individuals with cervical radiculopathy
Other: Survey study
Cervical Radiculopathy Impact Scale (CRIS) will be applied

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cervical Radiculopathy Impact Scale (CRIS)
Time Frame: 12 minutes
Cervical Radiculopathy Impact Scale was designed to evaluate measurement of symptoms and limitations in individuals with cervical radiculopathy.
12 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gazi University

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)

March 1, 2021

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

February 7, 2021

First Submitted That Met QC Criteria

February 7, 2021

First Posted (Actual)

February 11, 2021

Study Record Updates

Last Update Posted (Actual)

May 4, 2021

Last Update Submitted That Met QC Criteria

May 1, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26.01.2021-E.13997

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Supporting Information Type

  • Clinical Study Report (CSR)

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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