NCT07448883

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
10mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
May 2026May 2027

First Submitted

Initial submission to the registry

February 27, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 4, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

May 10, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2027

Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

12 months

First QC Date

February 27, 2026

Last Update Submit

May 10, 2026

Conditions

Keywords

Degenerative Cervical MyelopathyCervical Spondylotic MyelopathyModified Japanese Orthopaedic Association ScoremJOAReliabilityNeck Disability Index

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Day 1

Secondary Outcomes (1)

  • Nurick Grading System

    Day 1

Study Arms (1)

degenerative cervical miyelopathy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Democracy University

Buca, İzmir, 35570, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

SpondylosisSpinal Cord Compression

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesSpinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal Cord InjuriesWounds and Injuries

Central Study Contacts

Kadir Songür, Assoc. Prof.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Lecturer

Study Record Dates

First Submitted

February 27, 2026

First Posted

March 4, 2026

Study Start

May 10, 2026

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

May 30, 2027

Last Updated

May 13, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

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.

Locations