Cervical RadiculopathyNCT04749420
Translation, Cultural Adaptation, Reliability, and Validity of the Turkish Version of the Cervical Radiculopathy Impact Scale
An observational study of Cervical Radiculopathy and Cervical Radicular Pain, run by Gazi University at 1 site in Turkey (Türkiye).
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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cervical Radiculopathy, Cervical Radicular Pain, Cervical Radiculitis
- What is being tested?
- Survey study
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 1 Sep 2022
- 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: The study population will consist of individuals with cervical radiculpathy symptoms, diagnosis, and chronic pain on cervical spine region.
Who may be able to join
- Individuals with radiculopathy symptoms and diagnosis.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Halime ARIKAN
Ankara, None Selected, 06490
Halime ARIKAN, halimearikan92@gmail.com
About this study
The purpose of this study was to investigate adaptation, validity, and reliability of the Turkish version of the Cervical Radiculopathy Impact Scale (CRIS).
Read the 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.
- Conditions
- Cervical Radiculopathy, Cervical Radicular Pain, Cervical Radiculitis, Cervical Root Syndrome
- Being tested
- Survey study
- Keywords
- Cervical radiculopathy, Reliability, Validity, Cross-cultural adaptation
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey studyOther
Cervical Radiculopathy Impact Scale (CRIS) will be applied
| Study group | Role | What they receive |
|---|---|---|
| Patients group | Individuals with cervical radiculopathy Receives: Other: Survey study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical Radiculopathy Impact Scale (CRIS)
Cervical Radiculopathy Impact Scale was designed to evaluate measurement of symptoms and limitations in individuals with cervical radiculopathy.
Measured: 12 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start1 Mar 2021
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical RadiculopathyStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halime ARIKAN, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04749420
- Sponsor's protocol ID
- 26.01.2021-E.13997
- Status last verified
- May 2021
- First submitted
- 7 Feb 2021
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation, Cultural Adaptation, Reliability, and Validity of the Turkish Version of the Cervical Radiculopathy Impact Scale
- ClinicalTrials.gov ID
- NCT04749420
- Acronym / sponsor ID
- 26.01.2021-E.13997
- Conditions
- Cervical Radiculopathy, Cervical Radicular Pain, Cervical Radiculitis, Cervical Root Syndrome
- Keywords
- Cervical radiculopathy, Reliability, Validity, Cross-cultural adaptation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 11 Feb 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.
The purpose of this study was to investigate adaptation, validity, and reliability of the Turkish version of the Cervical Radiculopathy Impact Scale (CRIS).
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients group | – | Other: Survey studyIndividuals with cervical radiculopathy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of individuals with cervical radiculpathy symptoms, diagnosis, and chronic pain on cervical spine region.
Key inclusion criteria (1 listed)
- Individuals with radiculopathy symptoms and diagnosis.
Key exclusion criteria (4 listed)
- 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.
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 studyCervical Radiculopathy Impact Scale (CRIS) will be applied | Other | Patients group |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
- Individual participant dataSharing planned: Yes
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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.
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 Cervical Radiculopathy and Cervical Radicular Pain, run by Gazi 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 1 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: status not confirmed, as of the sponsor's last update on 4 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Halime ARIKAN, MSc. (+90 546 576 51 32, halimearikan92@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervical Radiculopathy Impact Scale (CRIS) (time frame: 12 minutes). 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 4 May 2021.