An observational study in Spondylosis, Cervical and Spinal Cord Compression, sponsored by Izmir Democracy University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-13.
Sponsored by Izmir Democracy University · Observational
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.
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.
142 studies on the registry are indexed under Spondylosis; 42 are open to participants now.
This study's planned enrollment of 70 is below the median of 100 across 36 observational studies indexed under Spondylosis.
Browse Spondylosis studies →Izmir Democracy University is the lead sponsor of 78 studies on the registry; 32 are open to participants now.
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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.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: 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.
Time frame: Day 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.
Time frame: Day 1
Plan to share: 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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Started May 2026 (actual). Primary completion is estimated for Apr 2027, 11 months after the start.
Of 18 observational studies under Spondylosis, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 74. This study's planned 11 months is below that.
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Izmir Democracy University