Cervical RadiculopathyCSCSNCT07823426
Cervical Spinal Cord Signal Abnormalities in Patients With Cervical Radicular Pain
An observational study of Cervical Radiculopathy and Cervical Myelomalacia, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study aims to determine the prevalence of cervical spinal cord signal abnormalities, including myelomalacia, among adult patients presenting to a tertiary pain clinic with cervical radicular pain. A total of 400 consecutive patients will be enrolled. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cervical Radiculopathy, Cervical Myelomalacia
- What is being tested?
- Clinical and Cervical MRI Assessment
- How many people
- 400 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2026to 31 Mar 2027
- How long will I take part?
- 1 Day
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will consist of 400 consecutive adult patients presenting to the tertiary Pain Medicine Clinic of Ankara Bilkent City Hospital with cervical radicular pain. Participants will be prospectively enrolled during routine clinical evaluation. Clinical and neurological examination findings, cervical MRI characteristics, and the treatment strategy selected by the treating physician will be recorded. No diagnostic or therapeutic intervention will be assigned by the study protocol.
Who may be able to join
- Age 18 years or older
- Presentation to the pain clinic with cervical radicular pain
- Clinical symptoms and/or examination findings consistent with cervical nerve root involvement
- Availability of a cervical magnetic resonance imaging (MRI) examination suitable for evaluation
- Completion of standardized neurological examination at the initial visit
- Ability and willingness to provide written informed consent
Who cannot join
- Previous cervical spine surgery
- Acute cervical spine trauma
- Known cervical spinal malignancy
- Active spinal infection
- Known inflammatory, demyelinating, or other non-degenerative spinal cord disease
- Severe cognitive impairment or communication difficulty preventing reliable clinical assessment
- Inadequate or non-diagnostic cervical MRI quality
- Refusal 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
Ankara Bilkent City Hospital
Ankara, Ankara, 06680
Ülkü Sabuncu, Assoc Prof, 90312 5526000 ext. 102-103, sabuncuulku@gmail.com
About this study
Official title: Prevalence of Cervical Spinal Cord Signal Abnormalities and Determinants of Treatment Selection in Patients With Cervical Radicular Pain: A Prospective Cohort Study
This prospective observational study aims to determine the prevalence of cervical spinal cord signal abnormalities, including myelomalacia, among adult patients presenting to a tertiary pain clinic with cervical radicular pain.
A total of 400 consecutive patients will be enrolled. Clinical and neurological examination findings, including the Hoffmann sign and other findings suggestive of cervical spinal cord involvement, will be recorded together with cervical magnetic resonance imaging (MRI) findings obtained as part of routine clinical care.
Read more
The primary outcome is the prevalence of cervical spinal cord signal abnormalities, including myelomalacia, on cervical MRI. Secondary outcomes include the treatment strategy selected during routine clinical care, clinical and radiological factors associated with treatment selection, the relationship between the Hoffmann sign and cervical spinal cord abnormalities, and referral for surgical evaluation.
This is an observational study. Participation in the study will not determine or alter diagnostic or treatment decisions, which will be made by the treating physician according to routine clinical practice.
- Conditions
- Cervical Radiculopathy, Cervical Myelomalacia
- Being tested
- Clinical and Cervical MRI Assessment
- Keywords
- Cervical Radicular Pain, Cervical Spinal Cord Signal Abnormality, Myelomalacia, Spinal Cord Compression, Hoffman
- Medical subject headings
- Radiculopathy, Spinal Cord Compression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical and Cervical MRI AssessmentDiagnostic test
Participants will undergo routine clinical and neurological evaluation, including assessment of the Hoffmann sign and other neurological findings, together with evaluation of cervical magnetic resonance imaging (MRI) findings. Cervical MRI findings, including spinal canal stenosis, spinal cord compression, intramedullary signal abnormalities, and myelomalacia, will be recorded. All assessments are performed as part of routine clinical care. No diagnostic procedure or treatment is assigned by the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Patients With Cervical Radicular Pain | Patients With Cervical Radicular Pain Receives: Diagnostic Test: Clinical and Cervical MRI Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Cervical Spinal Cord Signal Abnormalities Including Myelomalacia
The proportion of participants with cervical spinal cord signal abnormalities identified on cervical magnetic resonance imaging (MRI), including intramedullary T2-weighted signal abnormalities and findings consistent with myelomalacia, will be determined. The prevalence will be calculated as the number of participants with these MRI findings divided by the total number of enrolled participants with evaluable cervical MRI examinations.
Measured: At the initial clinical evaluation (baseline)
Secondary outcomes (4)
Planned Treatment Strategy
The treatment strategy selected during routine clinical care will be recorded for each participant. Management will be categorized as interventional pain procedure, medical treatment without intervention, referral for surgical evaluation, or other clinically appropriate management.
Measured: At the initial clinical evaluation (baseline)
Clinical and Radiological Factors Associated With Interventional Treatment Selection
The association between predefined clinical and radiological variables and the decision to plan an interventional pain procedure will be evaluated. Variables will include Hoffmann sign, motor deficit, hyperreflexia, Babinski sign, clonus, gait abnormality, central canal stenosis, spinal cord compression, intramedullary signal abnormality, and myelomalacia.
Measured: At the initial clinical evaluation (baseline)
Association Between Hoffmann Sign and Cervical Spinal Cord Signal Abnormalities
The relationship between Hoffmann sign status and cervical spinal cord abnormalities on MRI will be evaluated. The frequency of spinal cord signal abnormalities and myelomalacia will be compared between participants with positive and negative Hoffmann signs.
Measured: At the initial clinical evaluation (baseline)
Referral for Surgical Evaluation
The proportion of participants referred for neurosurgical or spine surgical evaluation following clinical and radiological assessment will be determined, and factors associated with referral will be explored.
Measured: At the initial clinical evaluation (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cervical RadiculopathyStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ülkü Sabuncu, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07823426
- Sponsor's protocol ID
- TABED2-26-2814
- Acronym
- CSCS
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data are not planned to be shared.
Publications
Glaser JA, Cure JK, Bailey KL, Morrow DL. Cervical spinal cord compression and the Hoffmann sign. Iowa Orthop J. 2001;21:49-52.
PubMed 11813951Zhou Y, Kim SD, Vo K, Riew KD. Prevalence of cervical myelomalacia in adult patients requiring a cervical magnetic resonance imaging. Spine (Phila Pa 1976). 2015 Feb 15;40(4):E248-52. doi: 10.1097/BRS.0000000000000718.
PubMed 25423302
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Cervical Spinal Cord Signal Abnormalities and Determinants of Treatment Selection in Patients With Cervical Radicular Pain: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07823426
- Acronym / sponsor ID
- CSCS / TABED2-26-2814
- Conditions
- Cervical Radiculopathy, Cervical Myelomalacia
- Keywords
- Cervical Radicular Pain, Cervical Spinal Cord Signal Abnormality, Myelomalacia, Spinal Cord Compression, Hoffman
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 16 Sep 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.
This prospective observational study aims to determine the prevalence of cervical spinal cord signal abnormalities, including myelomalacia, among adult patients presenting to a tertiary pain clinic with cervical radicular pain.
A total of 400 consecutive patients will be enrolled. Clinical and neurological examination findings, including the Hoffmann sign and other findings suggestive of cervical spinal cord involvement, will be recorded together with cervical magnetic resonance imaging (MRI) findings obtained as part of routine clinical care.
The primary outcome is the prevalence of cervical spinal cord signal abnormalities, including myelomalacia, on cervical MRI. Secondary outcomes include the treatment strategy selected during routine clinical care, clinical and radiological factors associated with treatment selection, the relationship between the Hoffmann sign and cervical spinal cord abnormalities, and referral for surgical evaluation.
This is an observational study. Participation in the study will not determine or alter diagnostic or treatment decisions, which will be made by the treating physician according to routine clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients With Cervical Radicular Pain | – | Diagnostic Test: Clinical and Cervical MRI AssessmentPatients With Cervical Radicular Pain |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will consist of 400 consecutive adult patients presenting to the tertiary Pain Medicine Clinic of Ankara Bilkent City Hospital with cervical radicular pain. Participants will be prospectively enrolled during routine clinical evaluation. Clinical and neurological examination findings, cervical MRI characteristics, and the treatment strategy selected by the treating physician will be recorded. No diagnostic or therapeutic intervention will be assigned by the study protocol.
Key inclusion criteria (6 listed)
- Age 18 years or older
- Presentation to the pain clinic with cervical radicular pain
- Clinical symptoms and/or examination findings consistent with cervical nerve root involvement
- Availability of a cervical magnetic resonance imaging (MRI) examination suitable for evaluation
- Completion of standardized neurological examination at the initial visit
Key exclusion criteria (8 listed)
- Previous cervical spine surgery
- Acute cervical spine trauma
- Known cervical spinal malignancy
- Active spinal infection
- Known inflammatory, demyelinating, or other non-degenerative spinal cord disease
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 |
|---|---|---|
| Clinical and Cervical MRI AssessmentParticipants will undergo routine clinical and neurological evaluation, including assessment of the Hoffmann sign and other neurological findings, together with evaluation of cervical magnetic resonance imaging (MRI) findings. Cervical MRI findings, including spinal canal stenosis, spinal cord compression, intramedullary signal abnormalities, and myelomalacia, will be recorded. All assessments are performed as part of routine clinical care. No diagnostic procedure or treatment is assigned by the study protocol. | Diagnostic test | Patients With Cervical Radicular Pain |
Primary outcome
Prevalence of Cervical Spinal Cord Signal Abnormalities Including Myelomalacia
Time frame: At the initial clinical evaluation (baseline)
The proportion of participants with cervical spinal cord signal abnormalities identified on cervical magnetic resonance imaging (MRI), including intramedullary T2-weighted signal abnormalities and findings consistent with myelomalacia, will be determined. The prevalence will be calculated as the number of participants with these MRI findings divided by the total number of enrolled participants with evaluable cervical MRI examinations.
4 secondary outcomes
Planned Treatment Strategy
Time frame: At the initial clinical evaluation (baseline)
Clinical and Radiological Factors Associated With Interventional Treatment Selection
Time frame: At the initial clinical evaluation (baseline)
Association Between Hoffmann Sign and Cervical Spinal Cord Signal Abnormalities
Time frame: At the initial clinical evaluation (baseline)
Referral for Surgical Evaluation
Time frame: At the initial clinical evaluation (baseline)
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 21 Oct 2026.
- Background: PubMed 11813951Glaser JA, Cure JK, Bailey KL, Morrow DL. Cervical spinal cord compression and the Hoffmann sign. Iowa Orthop J. 2001;21:49-52.
- Results publication: PubMed 25423302Zhou Y, Kim SD, Vo K, Riew KD. Prevalence of cervical myelomalacia in adult patients requiring a cervical magnetic resonance imaging. Spine (Phila Pa 1976). 2015 Feb 15;40(4):E248-52. doi: 10.1097/BRS.0000000000000718.
- Individual participant dataSharing planned: No. Individual participant data are not planned to be shared.
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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 Cervical Radiculopathy and Cervical Myelomalacia, run by Ankara City Hospital Bilkent 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 6 inclusion and 8 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 21 Oct 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 Ülkü Sabuncu, Assoc prof (905337085212, sabuncuulku@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Cervical Spinal Cord Signal Abnormalities Including Myelomalacia (time frame: At the initial clinical evaluation (baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07823426, which also lists 2 linked publications.
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 21 Oct 2026.