Spondylosis, CervicalNCT07448883
Validity of the Turkish Translation of the Modified JOA
An observational study of Spondylosis, Cervical and Spinal Cord Compression, run by Izmir Democracy University at 1 site in Turkey (Türkiye).
Trial summary
Degenerative cervical myelopathy (DCM) is the most common cause of non-traumatic spinal cord dysfunction in adults and may lead to progressive motor, sensory, and autonomic impairment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spondylosis, Cervical, Spinal Cord Compression
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 May 2026to 30 May 2027
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will include patients aged 18 years and older who have been diagnosed with degenerative cervical myelopathy based on clinical and radiological evaluation and who have applied to the Physical Medicine and Rehabilitation Outpatient Clinic and Neurosurgery Outpatient Clinic at İzmir Democracy University Buca Seyfi Demirsoy Education and Research Hospital.
Who may be able to join
- Adults aged 18 years and older
- Patients diagnosed with degenerative cervical myelopathy using clinical or magnetic resonance imaging
- Able to provide written informed consent to participate in the study
- Cognitive competence to understand Turkish forms and scales
Who cannot join
- Spinal cord injury due to trauma, tumor, infection, inflammatory diseases, etc., pathologies
- Previous cervical surgery
- Severe cognitive impairment or communication problems that would prevent participation in the study
- Subjects who were informed about the study but refused to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Izmir Democracy University
Buca, İzmir, 35570
Kadir Songür, 05054529231, kadir.93@gmail.com
About this study
Official title: Validity, Reliability, and Clinical Correlation Study of the Turkish Translation of the Modified JOA (Japanese Orthopedic Association) Cervical Myelopathy Score
Degenerative cervical myelopathy (DCM) is the most common cause of non-traumatic spinal cord dysfunction in adults and may lead to progressive motor, sensory, and autonomic impairment. Accurate and standardized assessment of neurological function is essential for clinical decision-making, prognostic evaluation, and comparison of treatment outcomes. The Modified Japanese Orthopaedic Association (mJOA) score is one of the most widely used clinician-based outcome measures for evaluating neurological status in patients with DCM. Although the mJOA has been translated and validated in several languages, no validated Turkish version currently exists.
This prospective, cross-sectional validation study aims to culturally adapt the mJOA score into Turkish and evaluate its validity, reliability, and clinical correlation in Turkish-speaking patients diagnosed with DCM. Adult patients (≥18 years) with clinically and radiologically confirmed DCM presenting to the outpatient clinics of Physical Medicine and Rehabilitation and Neurosurgery will be included. Previously obtained cervical magnetic resonance imaging will be reviewed retrospectively to determine myelomalacia levels, while clinical scales will be administered prospectively.
Read more
Construct validity will be assessed by examining correlations between the Turkish mJOA scores and the Neck Disability Index, as well as the Nurick grading system. Inter-rater reliability will be evaluated using the Intraclass Correlation Coefficient (ICC [2,1]) between two independent evaluators, and test-retest reliability will be assessed in clinically stable patients after 7-14 days. Feasibility will be evaluated by recording the administration time and potential difficulties during application.
This study is expected to provide a valid and reliable Turkish version of the mJOA score, facilitating standardized assessment of DCM in Turkish clinical practice and enabling comparability with international research.
Read the detailed description
Degenerative cervical myelopathy (DCM) represents the leading cause of non-traumatic spinal cord dysfunction in adults and is characterized by progressive neurological impairment involving upper and lower extremity motor function, sensory deficits, and sphincter dysfunction. Standardized and reliable clinical assessment tools are essential for determining disease severity, guiding treatment decisions, and ensuring comparability across clinical studies.
The Modified Japanese Orthopaedic Association (mJOA) score is a clinician-based functional assessment tool widely used to evaluate neurological status in patients with DCM. It assesses four domains: upper extremity motor function (0-5 points), lower extremity motor function (0-7 points), sensory function (0-3 points), and sphincter function (0-3 points), yielding a total score ranging from 0 to 18. Lower scores indicate more severe neurological impairment. Although the mJOA score has undergone cross-cultural adaptation and validation in several languages, a culturally adapted and psychometrically validated Turkish version is currently unavailable.
This study is designed as a prospective, cross-sectional validation study aiming to perform the cultural adaptation and psychometric evaluation of the Turkish version of the mJOA score in patients with DCM. The translation process was conducted using a standardized forward-backward translation methodology in accordance with internationally accepted cross-cultural adaptation guidelines.
Participants will include adult patients (≥18 years) with clinically and radiologically confirmed DCM who present to the outpatient clinics of Physical Medicine and Rehabilitation and Neurosurgery. Previously obtained cervical magnetic resonance imaging (MRI) scans will be reviewed retrospectively to determine the level of cervical myelomalacia. Demographic and clinical variables, including age, sex, body mass index, symptom duration, treatment status, and affected side, will be recorded.
Construct validity will be evaluated by analyzing correlations between Turkish mJOA total and subdomain scores and the Neck Disability Index (NDI), a validated Turkish instrument measuring cervical disability. Given that higher mJOA scores reflect better neurological function and higher NDI scores indicate greater disability, a significant negative correlation is hypothesized. Additionally, correlations between mJOA scores and the Nurick grading system will be assessed using Spearman's rank correlation analysis. Differences in mJOA scores across categorized Nurick severity groups will be analyzed using non-parametric statistical tests.
Inter-rater reliability will be assessed in at least 50 patients by two independent evaluators (an experienced clinician and a trained clinician) using the Intraclass Correlation Coefficient (ICC [2,1]). Test-retest reliability will be evaluated in clinically stable patients after a 7-14-day interval using ICC analysis. Floor and ceiling effects will be examined and considered present if more than 15% of participants achieve the lowest or highest possible scores.
Feasibility will be assessed by recording the time required to administer the Turkish mJOA and documenting any comprehension or implementation difficulties. No interventional procedures are involved in this study, and no adverse events are anticipated.
The results of this study are expected to establish a valid, reliable, and feasible Turkish version of the mJOA score, enabling standardized assessment of DCM severity in Turkish clinical practice and facilitating international research collaboration and outcome comparison.
- Conditions
- Spondylosis, Cervical, Spinal Cord Compression
- Keywords
- Degenerative Cervical Myelopathy, Cervical Spondylotic Myelopathy, Modified Japanese Orthopaedic Association Score, mJOA, Reliability, Neck Disability Index
- Medical subject headings
- Spondylosis, Spinal Cord Compression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| degenerative cervical miyelopathy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Japanese Orthopedic Association Score
The Modified Japanese Orthopedic Association Score is a clinician-based functional assessment scale used to evaluate neurological function in patients with DSM. The scale covers four main areas: upper extremity motor function, lower extremity motor function, sensory function, and bladder (sphincter) function. Upper extremity motor function is scored from 0 to 5 points, lower extremity motor function from 0 to 7 points, sensory function from 0 to 3 points, and sphincter function from 0 to 3 points. The total score ranges from 0 to 18. Lower scores indicate more severe neurological dysfunction and poorer clinical status, while higher scores indicate better neurological function and clinical improvement. The scale is applied based on clinical examination findings and is a practical assessment tool that can be completed in a short time.
Measured: Day 1
Neck Disability Index
The Neck Disability Index is an adaptation of the Oswestry Disability Index for the cervical region and is a widely used 10-item questionnaire for assessing cervical dysfunction and neck pain. Each item is scored between 0 (no disability) and 5 (complete disability). The total score ranges from 0 to 50; a higher score indicates greater functional limitation. The questionnaire has established validity and reliability in Turkish.
Measured: Day 1
Secondary outcomes (1)
Nurick Grading System
The Nurick grading system is a clinician-based classification system developed specifically to assess walking function and the level of independence in activities of daily living in patients with degenerative cervical myelopathy. The scale consists of six grades and is scored from 0 to 5. Grade 0 indicates the presence of root symptoms without myelopathy findings; Grades 1 and 2 indicate mild walking difficulties; Grade 3 indicates limited work capacity despite being able to walk independently; Grade 4 indicates inability to walk without assistance; and Grade 5 indicates dependence on a bed or chair. Lower grades indicate a milder clinical picture, while higher grades indicate more advanced neurological function loss.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start10 May 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spondylosis, CervicalStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Izmir Democracy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kadir Songur, Izmir Democracy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07448883
- Sponsor's protocol ID
- 2025 549
- Status last verified
- May 2026
- First submitted
- 27 Feb 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the data contain potentially identifiable sensitive clinical information, and sharing was not covered in the original informed consent provided to participants. Additionally, institutional and national data protection regulations limit the transfer of raw, de-identified individual-level data outside the research team.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity, Reliability, and Clinical Correlation Study of the Turkish Translation of the Modified JOA (Japanese Orthopedic Association) Cervical Myelopathy Score
- ClinicalTrials.gov ID
- NCT07448883
- Acronym / sponsor ID
- 2025 549
- Conditions
- Spondylosis, Cervical, Spinal Cord Compression
- Keywords
- Degenerative Cervical Myelopathy, Cervical Spondylotic Myelopathy, Modified Japanese Orthopaedic Association Score, mJOA, Reliability, Neck Disability Index
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Izmir Democracy UniversityUniversity, hospital or other
- Study start
- 10 May 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 4 Mar 2026 (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.
Degenerative cervical myelopathy (DCM) is the most common cause of non-traumatic spinal cord dysfunction in adults and may lead to progressive motor, sensory, and autonomic impairment. Accurate and standardized assessment of neurological function is essential for clinical decision-making, prognostic evaluation, and comparison of treatment outcomes. The Modified Japanese Orthopaedic Association (mJOA) score is one of the most widely used clinician-based outcome measures for evaluating neurological status in patients with DCM. Although the mJOA has been translated and validated in several languages, no validated Turkish version currently exists.
This prospective, cross-sectional validation study aims to culturally adapt the mJOA score into Turkish and evaluate its validity, reliability, and clinical correlation in Turkish-speaking patients diagnosed with DCM. Adult patients (≥18 years) with clinically and radiologically confirmed DCM presenting to the outpatient clinics of Physical Medicine and Rehabilitation and Neurosurgery will be included. Previously obtained cervical magnetic resonance imaging will be reviewed retrospectively to determine myelomalacia levels, while clinical scales will be administered prospectively.
Construct validity will be assessed by examining correlations between the Turkish mJOA scores and the Neck Disability Index, as well as the Nurick grading system. Inter-rater reliability will be evaluated using the Intraclass Correlation Coefficient (ICC [2,1]) between two independent evaluators, and test-retest reliability will be assessed in clinically stable patients after 7-14 days. Feasibility will be evaluated by recording the administration time and potential difficulties during application.
This study is expected to provide a valid and reliable Turkish version of the mJOA score, facilitating standardized assessment of DCM in Turkish clinical practice and enabling comparability with international research.
Detailed description
Degenerative cervical myelopathy (DCM) represents the leading cause of non-traumatic spinal cord dysfunction in adults and is characterized by progressive neurological impairment involving upper and lower extremity motor function, sensory deficits, and sphincter dysfunction. Standardized and reliable clinical assessment tools are essential for determining disease severity, guiding treatment decisions, and ensuring comparability across clinical studies.
The Modified Japanese Orthopaedic Association (mJOA) score is a clinician-based functional assessment tool widely used to evaluate neurological status in patients with DCM. It assesses four domains: upper extremity motor function (0-5 points), lower extremity motor function (0-7 points), sensory function (0-3 points), and sphincter function (0-3 points), yielding a total score ranging from 0 to 18. Lower scores indicate more severe neurological impairment. Although the mJOA score has undergone cross-cultural adaptation and validation in several languages, a culturally adapted and psychometrically validated Turkish version is currently unavailable.
This study is designed as a prospective, cross-sectional validation study aiming to perform the cultural adaptation and psychometric evaluation of the Turkish version of the mJOA score in patients with DCM. The translation process was conducted using a standardized forward-backward translation methodology in accordance with internationally accepted cross-cultural adaptation guidelines.
Participants will include adult patients (≥18 years) with clinically and radiologically confirmed DCM who present to the outpatient clinics of Physical Medicine and Rehabilitation and Neurosurgery. Previously obtained cervical magnetic resonance imaging (MRI) scans will be reviewed retrospectively to determine the level of cervical myelomalacia. Demographic and clinical variables, including age, sex, body mass index, symptom duration, treatment status, and affected side, will be recorded.
Construct validity will be evaluated by analyzing correlations between Turkish mJOA total and subdomain scores and the Neck Disability Index (NDI), a validated Turkish instrument measuring cervical disability. Given that higher mJOA scores reflect better neurological function and higher NDI scores indicate greater disability, a significant negative correlation is hypothesized. Additionally, correlations between mJOA scores and the Nurick grading system will be assessed using Spearman's rank correlation analysis. Differences in mJOA scores across categorized Nurick severity groups will be analyzed using non-parametric statistical tests.
Inter-rater reliability will be assessed in at least 50 patients by two independent evaluators (an experienced clinician and a trained clinician) using the Intraclass Correlation Coefficient (ICC [2,1]). Test-retest reliability will be evaluated in clinically stable patients after a 7-14-day interval using ICC analysis. Floor and ceiling effects will be examined and considered present if more than 15% of participants achieve the lowest or highest possible scores.
Feasibility will be assessed by recording the time required to administer the Turkish mJOA and documenting any comprehension or implementation difficulties. No interventional procedures are involved in this study, and no adverse events are anticipated.
The results of this study are expected to establish a valid, reliable, and feasible Turkish version of the mJOA score, enabling standardized assessment of DCM severity in Turkish clinical practice and facilitating international research collaboration and outcome comparison.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| degenerative cervical miyelopathy | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include patients aged 18 years and older who have been diagnosed with degenerative cervical myelopathy based on clinical and radiological evaluation and who have applied to the Physical Medicine and Rehabilitation Outpatient Clinic and Neurosurgery Outpatient Clinic at İzmir Democracy University Buca Seyfi Demirsoy Education and Research Hospital.
Key inclusion criteria (4 listed)
- Adults aged 18 years and older
- Patients diagnosed with degenerative cervical myelopathy using clinical or magnetic resonance imaging
- Able to provide written informed consent to participate in the study
- Cognitive competence to understand Turkish forms and scales
Key exclusion criteria (4 listed)
- Spinal cord injury due to trauma, tumor, infection, inflammatory diseases, etc., pathologies
- Previous cervical surgery
- Severe cognitive impairment or communication problems that would prevent participation in the study
- Subjects who were informed about the study but refused to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Modified Japanese Orthopedic Association Score
Time frame: Day 1
The Modified Japanese Orthopedic Association Score is a clinician-based functional assessment scale used to evaluate neurological function in patients with DSM. The scale covers four main areas: upper extremity motor function, lower extremity motor function, sensory function, and bladder (sphincter) function. Upper extremity motor function is scored from 0 to 5 points, lower extremity motor function from 0 to 7 points, sensory function from 0 to 3 points, and sphincter function from 0 to 3 points. The total score ranges from 0 to 18. Lower scores indicate more severe neurological dysfunction and poorer clinical status, while higher scores indicate better neurological function and clinical improvement. The scale is applied based on clinical examination findings and is a practical assessment tool that can be completed in a short time.
Neck Disability Index
Time frame: Day 1
The Neck Disability Index is an adaptation of the Oswestry Disability Index for the cervical region and is a widely used 10-item questionnaire for assessing cervical dysfunction and neck pain. Each item is scored between 0 (no disability) and 5 (complete disability). The total score ranges from 0 to 50; a higher score indicates greater functional limitation. The questionnaire has established validity and reliability in Turkish.
1 secondary outcome
Nurick Grading System
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the data contain potentially identifiable sensitive clinical information, and sharing was not covered in the original informed consent provided to participants. Additionally, institutional and national data protection regulations limit the transfer of raw, de-identified individual-level data outside the research team.
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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.
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 Spondylosis, Cervical and Spinal Cord Compression, run by Izmir Democracy 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 4 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: looking for participants now, as of the sponsor's last update on 13 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kadir Songür, Assoc. Prof. (+905054529231, kadir.93@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Japanese Orthopedic Association Score (time frame: Day 1). The study lists 2 primary outcomes in all. 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 13 May 2026.