Degenerative Cervical Spinal StenosisNCT06528730
A Novel Surgical Criteria for Degenerative Cervical Myelopathy in Chinese Ethnicity
An observational study of Degenerative Cervical Spinal Stenosis, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Degenerative Cervical Myelopathy (DCM) is an age-related irreversible degenerative disease predominantly affecting the elderly aged 50 and over. DCM is usually triggered by ossification of the posterior longitudinal ligament or ossification of ligamentum flavum or prolapsed intervertebral disc over the cervical spine. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Degenerative Cervical Spinal Stenosis
- What is being tested?
- DCM
- How many people
- 100 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Oct 2023to 30 Jul 2050
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 100 patient with Degenerative Cervical Myelopathy will be recruited in DKCH
Who may be able to join
- MRI confirmed Chinese DCM surgical candidates
- All gender
- Older than 45 years old
- Independent walkers
- No previous cervical spinal surgery
- Cognitively capable of following instructions.
Who cannot join
- Active diagnosis of tuberculosis spine
- Lumbar spinal diseases
- Extra-pyramidal
- Cerebral or cerebellar disorders
- Peripheral neuropathies
- Previous spinal operations
- Unable to walk independently with or without aids
- Non-communicable subjects and cognitively incapable of expressing their symptoms clearly
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The Duchess of Kent Children's Hospital at Sandy Bay
Hong Kong, 000
Karlen Ka Pui Law, M. Phil, 852-29740531, karlenhk@connect.hku.hk
About this study
Degenerative Cervical Myelopathy (DCM) is an age-related irreversible degenerative disease predominantly affecting the elderly aged 50 and over. DCM is usually triggered by ossification of the posterior longitudinal ligament or ossification of ligamentum flavum or prolapsed intervertebral disc over the cervical spine. Specific clinical signs characterized the presence of cervical spinal cord compression; including Hoffmann's sign, Finger Escape Sign, Scapulohumeral Reflex, and Reverse Supinator Reflex. Hand numbness, clumsiness, and gait disturbance. These are featured clinical manifestations and well-known indicators for detailed clinical and radiographic investigation, such as Magnetic Resonance Imaging (MRI) for diagnosis and surgical planning.
Surgical intervention is considered to be the most effective treatment for DCM worldwide. It is the only evidence-based treatment to halt disease progression and allow modest improvement in function and quality of life. DCM progression is not specific to predict the timing for surgery, though it is still debated. Length of symptoms, pre-operative Modified Japanese Orthopaedic Association Scoring System for Cervical Myelopathy (mJOA) and physical performance are suggested as recovery predictors in DCM.
In current practice, the offer of surgical treatment is entirely based on the combination of the evidence of cord compression in Magnetic Resonance Imaging (MRI) and mJOA. DCM who are at risk of critical neurological deficits have a reduced anteroposterior diameter of the spinal canal less than 9 mm or cross-sectional area of the spinal cord less than 40 sq. mm; mJOA less than 13 with evidence of functional deterioration will be offered with surgical intervention. MRI and mJOA are used as the golden standard for the indication of surgical intervention in the aspect of radiological deformities and self- perceived functional deficits. The concern on the clinical predictor, the physical performance, was overlooked and lacked a compromised criterion in the physical performance tests for surgical decisions. Therefore, this study aims to develop DCM-specific criteria from physical performance tests in predicting the surgical indication for DCM in the Chinese population.
Read the detailed description
Degenerative Cervical Myelopathy (DCM) is a prevalent degenerative spinal disease that often goes unnoticed by general clinicians due to its non-specific and subtle signs and symptoms in its early stages. Delayed identification of DCM may lead to poor surgical outcomes or permanent disability, impacting the quality of life of affected individuals.
Incoordination in hand and gait movements are early signs of DCM that worsen with disease progression. Despite validated performance tests for DCM, there is currently no objective criterion for functional deficits in aiding clinical decision-making for surgery or diagnosis.
To meet the pressing global need for objective functional criteria, this study aims to develop surgical criteria specific to DCM. This will involve using physical performance tests, in addition to evaluating MRI findings of cord compression, clinical signs, and the modified Japanese Orthopedic Association (mJOA). By expediting the surgical decision-making process, we hope to improve recovery outcomes for individuals with DCM worldwide
- Conditions
- Degenerative Cervical Spinal Stenosis
- Being tested
- DCM
- Keywords
- Degenerative cervical myelopathy, diagnosis, physical performance tests, surgeical criteria, functional deficits
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCMDiagnostic test
Confirm degenerative cervical myelopathy by Orthopaedic surgeon and MRI
What is being measured
The primary outcome is the main question the study is designed to answer.
10-second Grip and Release test (GR)
Counting the no. of grip-release repetitions made in 10 seconds
Measured: 24 months
10-second Stepping Test (SST) - no. of steps made in 10 seconds
Counting the no. of stepping repetitions made in 10 seconds
Measured: 24 months
Foot Tapping Test (FTT)
Counting the no. of foot taps repetitions made in 10 seconds
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start1 Oct 2023
- Primary completion30 Jan 2045 (estimated)
- Study completion30 Jul 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Degenerative Cervical Spinal StenosisStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Law Ka Pui Karlen, The University of Hong Kong
- Investigators
- Karlen Ka-pui Law, M. Phil, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06528730
- Sponsor's protocol ID
- UW 23-242
- Status last verified
- May 2026
- First submitted
- 7 Jul 2024
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD sharing is not expected
Publications
Fehlings MG, Tetreault LA, Riew KD, Middleton JW, Aarabi B, Arnold PM, Brodke DS, Burns AS, Carette S, Chen R, Chiba K, Dettori JR, Furlan JC, Harrop JS, Holly LT, Kalsi-Ryan S, Kotter M, Kwon BK, Martin AR, Milligan J, Nakashima H, Nagoshi N, Rhee J, Singh A, Skelly AC, Sodhi S, Wilson JR, Yee A, Wang JC. A Clinical Practice Guideline for the Management of Patients With Degenerative Cervical Myelopathy: Recommendations for Patients With Mild, Moderate, and Severe Disease and Nonmyelopathic Patients With Evidence of Cord Compression. Global Spine J. 2017 Sep;7(3 Suppl):70S-83S. doi: 10.1177/2192568217701914. Epub 2017 Sep 5.
PubMed 29164035Hilton B, Tempest-Mitchell J, Davies B, Kotter M. Assessment of degenerative cervical myelopathy differs between specialists and may influence time to diagnosis and clinical outcomes. PLoS One. 2018 Dec 17;13(12):e0207709. doi: 10.1371/journal.pone.0207709. eCollection 2018.
PubMed 30557368Tetreault L, Kopjar B, Nouri A, Arnold P, Barbagallo G, Bartels R, Qiang Z, Singh A, Zileli M, Vaccaro A, Fehlings MG. The modified Japanese Orthopaedic Association scale: establishing criteria for mild, moderate and severe impairment in patients with degenerative cervical myelopathy. Eur Spine J. 2017 Jan;26(1):78-84. doi: 10.1007/s00586-016-4660-8. Epub 2016 Jun 24.
PubMed 27342612Yukawa Y, Nakashima H, Ito K, Machino M, Kanbara S, Kato F. Quantifiable tests for cervical myelopathy; 10-s grip and release test and 10-s step test: standard values and aging variation from 1230 healthy volunteers. J Orthop Sci. 2013 Jul;18(4):509-13. doi: 10.1007/s00776-013-0381-6. Epub 2013 Apr 6.
PubMed 23564077Pribble BA, Black CD, Larson DJ, Larson RD. An evaluation of the reliability of the foot-tapping test in a healthy sample. Foot (Edinb). 2021 Sep;48:101851. doi: 10.1016/j.foot.2021.101851. Epub 2021 Jul 12.
PubMed 34385026Nakashima H, Yukawa Y, Ito K, Machino M, Kanbara S, Morita D, Imagama S, Hamajima N, Ishiguro N, Kato F. Validity of the 10-s step test: prospective study comparing it with the 10-s grip and release test and the 30-m walking test. Eur Spine J. 2011 Aug;20(8):1318-22. doi: 10.1007/s00586-011-1733-6. Epub 2011 Mar 6.
PubMed 21380747Kalsi-Ryan S, Singh A, Massicotte EM, Arnold PM, Brodke DS, Norvell DC, Hermsmeyer JT, Fehlings MG. Ancillary outcome measures for assessment of individuals with cervical spondylotic myelopathy. Spine (Phila Pa 1976). 2013 Oct 15;38(22 Suppl 1):S111-22. doi: 10.1097/BRS.0b013e3182a7f499.
PubMed 23963009Machino M, Ando K, Kobayashi K, Morozumi M, Tanaka S, Ito K, Kato F, Ishiguro N, Imagama S. Cut off value in each gender and decade of 10-s grip and release and 10-s step test: A comparative study between 454 patients with cervical spondylotic myelopathy and 818 healthy subjects. Clin Neurol Neurosurg. 2019 Sep;184:105414. doi: 10.1016/j.clineuro.2019.105414. Epub 2019 Jul 5.
PubMed 31306894Yukawa Y, Kato F, Ito K, Horie Y, Nakashima H, Masaaki M, Ito ZY, Wakao N. "Ten second step test" as a new quantifiable parameter of cervical myelopathy. Spine (Phila Pa 1976). 2009 Jan 1;34(1):82-6. doi: 10.1097/BRS.0b013e31818e2b19.
PubMed 19127165
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Surgical Criteria for Degenerative Cervical Myelopathy in Chinese Ethnicity
- ClinicalTrials.gov ID
- NCT06528730
- Acronym / sponsor ID
- UW 23-242
- Conditions
- Degenerative Cervical Spinal Stenosis
- Keywords
- Degenerative cervical myelopathy, diagnosis, physical performance tests, surgeical criteria, functional deficits
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Jan 2045 (estimated)
- Study completion
- 30 Jul 2050 (estimated)
- First posted
- 30 Jul 2024 (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 an age-related irreversible degenerative disease predominantly affecting the elderly aged 50 and over. DCM is usually triggered by ossification of the posterior longitudinal ligament or ossification of ligamentum flavum or prolapsed intervertebral disc over the cervical spine. Specific clinical signs characterized the presence of cervical spinal cord compression; including Hoffmann's sign, Finger Escape Sign, Scapulohumeral Reflex, and Reverse Supinator Reflex. Hand numbness, clumsiness, and gait disturbance. These are featured clinical manifestations and well-known indicators for detailed clinical and radiographic investigation, such as Magnetic Resonance Imaging (MRI) for diagnosis and surgical planning.
Surgical intervention is considered to be the most effective treatment for DCM worldwide. It is the only evidence-based treatment to halt disease progression and allow modest improvement in function and quality of life. DCM progression is not specific to predict the timing for surgery, though it is still debated. Length of symptoms, pre-operative Modified Japanese Orthopaedic Association Scoring System for Cervical Myelopathy (mJOA) and physical performance are suggested as recovery predictors in DCM.
In current practice, the offer of surgical treatment is entirely based on the combination of the evidence of cord compression in Magnetic Resonance Imaging (MRI) and mJOA. DCM who are at risk of critical neurological deficits have a reduced anteroposterior diameter of the spinal canal less than 9 mm or cross-sectional area of the spinal cord less than 40 sq. mm; mJOA less than 13 with evidence of functional deterioration will be offered with surgical intervention. MRI and mJOA are used as the golden standard for the indication of surgical intervention in the aspect of radiological deformities and self- perceived functional deficits. The concern on the clinical predictor, the physical performance, was overlooked and lacked a compromised criterion in the physical performance tests for surgical decisions. Therefore, this study aims to develop DCM-specific criteria from physical performance tests in predicting the surgical indication for DCM in the Chinese population.
Detailed description
Degenerative Cervical Myelopathy (DCM) is a prevalent degenerative spinal disease that often goes unnoticed by general clinicians due to its non-specific and subtle signs and symptoms in its early stages. Delayed identification of DCM may lead to poor surgical outcomes or permanent disability, impacting the quality of life of affected individuals.
Incoordination in hand and gait movements are early signs of DCM that worsen with disease progression. Despite validated performance tests for DCM, there is currently no objective criterion for functional deficits in aiding clinical decision-making for surgery or diagnosis.
To meet the pressing global need for objective functional criteria, this study aims to develop surgical criteria specific to DCM. This will involve using physical performance tests, in addition to evaluating MRI findings of cord compression, clinical signs, and the modified Japanese Orthopedic Association (mJOA). By expediting the surgical decision-making process, we hope to improve recovery outcomes for individuals with DCM worldwide
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 100 patient with Degenerative Cervical Myelopathy will be recruited in DKCH
Key inclusion criteria (6 listed)
- MRI confirmed Chinese DCM surgical candidates
- All gender
- Older than 45 years old
- Independent walkers
- No previous cervical spinal surgery
Key exclusion criteria (8 listed)
- Active diagnosis of tuberculosis spine
- Lumbar spinal diseases
- Extra-pyramidal
- Cerebral or cerebellar disorders
- Peripheral neuropathies
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 |
|---|---|---|
| DCMConfirm degenerative cervical myelopathy by Orthopaedic surgeon and MRI | Diagnostic test | – |
Primary outcome
10-second Grip and Release test (GR)
Time frame: 24 months
Counting the no. of grip-release repetitions made in 10 seconds
10-second Stepping Test (SST) - no. of steps made in 10 seconds
Time frame: 24 months
Counting the no. of stepping repetitions made in 10 seconds
Foot Tapping Test (FTT)
Time frame: 24 months
Counting the no. of foot taps repetitions made in 10 seconds
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 20 May 2026.
- Results publication: PubMed 29164035Fehlings MG, Tetreault LA, Riew KD, Middleton JW, Aarabi B, Arnold PM, Brodke DS, Burns AS, Carette S, Chen R, Chiba K, Dettori JR, Furlan JC, Harrop JS, Holly LT, Kalsi-Ryan S, Kotter M, Kwon BK, Martin AR, Milligan J, Nakashima H, Nagoshi N, Rhee J, Singh A, Skelly AC, Sodhi S, Wilson JR, Yee A, Wang JC. A Clinical Practice Guideline for the Management of Patients With Degenerative Cervical Myelopathy: Recommendations for Patients With Mild, Moderate, and Severe Disease and Nonmyelopathic Patients With Evidence of Cord Compression. Global Spine J. 2017 Sep;7(3 Suppl):70S-83S. doi: 10.1177/2192568217701914. Epub 2017 Sep 5.
- Results publication: PubMed 30557368Hilton B, Tempest-Mitchell J, Davies B, Kotter M. Assessment of degenerative cervical myelopathy differs between specialists and may influence time to diagnosis and clinical outcomes. PLoS One. 2018 Dec 17;13(12):e0207709. doi: 10.1371/journal.pone.0207709. eCollection 2018.
- Results publication: PubMed 27342612Tetreault L, Kopjar B, Nouri A, Arnold P, Barbagallo G, Bartels R, Qiang Z, Singh A, Zileli M, Vaccaro A, Fehlings MG. The modified Japanese Orthopaedic Association scale: establishing criteria for mild, moderate and severe impairment in patients with degenerative cervical myelopathy. Eur Spine J. 2017 Jan;26(1):78-84. doi: 10.1007/s00586-016-4660-8. Epub 2016 Jun 24.
- Results publication: PubMed 23564077Yukawa Y, Nakashima H, Ito K, Machino M, Kanbara S, Kato F. Quantifiable tests for cervical myelopathy; 10-s grip and release test and 10-s step test: standard values and aging variation from 1230 healthy volunteers. J Orthop Sci. 2013 Jul;18(4):509-13. doi: 10.1007/s00776-013-0381-6. Epub 2013 Apr 6.
- Results publication: PubMed 34385026Pribble BA, Black CD, Larson DJ, Larson RD. An evaluation of the reliability of the foot-tapping test in a healthy sample. Foot (Edinb). 2021 Sep;48:101851. doi: 10.1016/j.foot.2021.101851. Epub 2021 Jul 12.
- Results publication: PubMed 21380747Nakashima H, Yukawa Y, Ito K, Machino M, Kanbara S, Morita D, Imagama S, Hamajima N, Ishiguro N, Kato F. Validity of the 10-s step test: prospective study comparing it with the 10-s grip and release test and the 30-m walking test. Eur Spine J. 2011 Aug;20(8):1318-22. doi: 10.1007/s00586-011-1733-6. Epub 2011 Mar 6.
- Results publication: PubMed 23963009Kalsi-Ryan S, Singh A, Massicotte EM, Arnold PM, Brodke DS, Norvell DC, Hermsmeyer JT, Fehlings MG. Ancillary outcome measures for assessment of individuals with cervical spondylotic myelopathy. Spine (Phila Pa 1976). 2013 Oct 15;38(22 Suppl 1):S111-22. doi: 10.1097/BRS.0b013e3182a7f499.
- Results publication: PubMed 31306894Machino M, Ando K, Kobayashi K, Morozumi M, Tanaka S, Ito K, Kato F, Ishiguro N, Imagama S. Cut off value in each gender and decade of 10-s grip and release and 10-s step test: A comparative study between 454 patients with cervical spondylotic myelopathy and 818 healthy subjects. Clin Neurol Neurosurg. 2019 Sep;184:105414. doi: 10.1016/j.clineuro.2019.105414. Epub 2019 Jul 5.
- Results publication: PubMed 19127165Yukawa Y, Kato F, Ito K, Horie Y, Nakashima H, Masaaki M, Ito ZY, Wakao N. "Ten second step test" as a new quantifiable parameter of cervical myelopathy. Spine (Phila Pa 1976). 2009 Jan 1;34(1):82-6. doi: 10.1097/BRS.0b013e31818e2b19.
- Individual participant dataSharing planned: No. IPD sharing is not expected
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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.
Karlen Ka-pui Law, M. Phil principal investigator
The University of Hong Kong
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 Degenerative Cervical Spinal Stenosis, run by The University of Hong Kong at 1 site in Hong Kong.
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 20 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 Hong Kong. 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 Karlen Ka-pui Law, M. Phil (29740531, karlenhk@connect.hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10-second Grip and Release test (GR) (time frame: 24 months). The study lists 3 primary outcomes in all. 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 NCT06528730, which also lists 9 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 20 May 2026.