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

Cervical Radiculopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04749420
• Other study ID #: 26.01.2021-E.13997
• Status: Recruiting
• Start date: March 1, 2021
• Est. completion date: September 1, 2022

Study information

• Verified date: May 2021
• Source: Gazi University
• Contact: Halime ARIKAN, MSc.
• Phone: +90 546 576 51 32
• Email: halimearikan92[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study was to investigate adaptation, validity, and reliability of the Turkish version of the Cervical Radiculopathy Impact Scale (CRIS).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Radicular Pain
• Cervical Radiculitis
• Cervical Radiculopathy
• Cervical Root Syndrome
• Radiculopathy

Intervention

Other:
• Survey study
Cervical Radiculopathy Impact Scale (CRIS) will be applied

Locations

Country	Name	City	State
Turkey	Halime ARIKAN	Ankara	None Selected

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cervical Radiculopathy Impact Scale (CRIS)	Cervical Radiculopathy Impact Scale was designed to evaluate measurement of symptoms and limitations in individuals with cervical radiculopathy.	12 minutes