Degenerative Cervical MyelopathyCADET-DCMNCT07358273
Conservative Care Versus Decompression Trial for Degenerative Cervical Myelopathy Pilot
A study testing Decompression Surgery and Conservative Care in people with Degenerative Cervical Myelopathy, run by McMaster University.
Trial summary
This study is a pilot randomized clinical trial designed to test whether it is feasible to conduct a larger study comparing two standard treatments for mild degenerative cervical myelopathy (DCM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Cervical Myelopathy
- What is being tested?
- Decompression Surgery and Conservative Care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Jun 2028
- Phase
- Interventional
- 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
Who may be able to join
- 18 years of age or older
- Show evidence of spinal cord compression between C2 and T1 on MRI or CT myelography conducted within 2 years of enrollment
- Present with mild DCM defined as a score of 15-17 on the modified Japanese Orthopaedic Association (mJOA) score
Who cannot join
- Clinical suspicion that myelopathic symptoms are exacerbated or caused by another neurologic condition (i.e. amyotrophic lateral sclerosis, multiple sclerosis, syringomyelia, peripheral neuropathy)
- Demonstrate ossification of the posterior longitudinal ligament (OPLL)
- Previous cervical spine surgery
- Report known or suspected tandem symptomatic thoracic or lumbar spinal stenosis
- Present with an acute traumatic spinal cord injury (i.e., central cord syndrome)
- Have a prior history of an acute spinal cord injury
Show all 10Show fewer
- Have spinal cord compression due to an infectious or oncologic process
- Inflammatory arthritis
- Significant active health-related comorbidity (ASA Class IV or higher)
- English language ability insufficient to complete outcome questionnaires
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Conservative Care Versus Decompression Trial for Degenerative Cervical Myelopathy Pilot: A Multicenter Randomized Controlled Feasibility Trial
This study is a pilot randomized clinical trial designed to test whether it is feasible to conduct a larger study comparing two standard treatments for mild degenerative cervical myelopathy (DCM).
The main questions it aims to answer are:
Read more
- Can enough participants be recruited and successfully complete follow-up assessments?
- Will participants adhere to their assigned treatment?
Researchers will compare two groups:
- Surgical group: Participants receive decompressive spine surgery (with or without fusion).
- Conservative care group: Participants follow a structured program that includes education, fall prevention strategies, and tailored exercises.
Participants will:
- Complete baseline and follow-up assessments at 6 weeks, 6 months, and 12 months.
- In the surgical group: undergo surgery within 12 weeks of randomization and receive standard post-operative care.
- In the conservative care group: follow a 6-week progressive exercise program and continue self-management strategies.
- Complete a monthly online symptom monitoring questionnaire
- Conditions
- Degenerative Cervical Myelopathy
- Being tested
- Decompression Surgery, Conservative Care
- Keywords
- myelopathy, spinal cord diseases, surgery, conservative care, spine
- Medical subject headings
- Spinal Cord Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decompression SurgeryProcedure or surgery
Surgical decompression of the cervical spine
Conservative CareOther
Conservative care Program for cervical myelopathy
| Study group | Role | What they receive |
|---|---|---|
| Conservative Care | Active comparator | Standard of care intervention Receives: Other: Conservative Care |
| Surgical Decompression | Active comparator | Standard of care intervention Receives: Procedure: Decompression Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consent proportion
Total number of participants randomized/ total number of patients approached
Measured: Enrollment
Follow-up completion
Number of participants with 6-month follow up completed/ number of participants randomized
Measured: 6 month follow-up
Adherence to intervention
Number of participants who proceed with allocated intervention/ number of participants randomized
Measured: 6 months after enrollment
Secondary outcomes (10)
Patient-derived Modified Japanese Orthopaedic Association Scale (P-mJOA)
Patient reported outcome assessing (i) upper extremity sensation, (ii) upper extremity motor function, (iii) lower extremity motor function, and (iv) sphincter function. It is used to grade DCM severity, and scored between 0 and 18. Scores of 18 indicate no dysfunction, 15 to 17 indicate mild DCM, 12 to 14 indicate moderate DCM, 11 and lower indicating severe DCM.
Measured: Baseline, 6 months, 12 months
Cervical Myelopathy Severity Index (CMSI)
The Cervical Myelopathy Severity Index (CSMI) assesses neurological function. It is a patient-completed 14-item measure for patients with DCM to evaluate symptom severity and functional limitations. Items span dexterity, balance/gait, pain, sensory impairment, and sphincter dysfunction. Each item is rated on a 4-point scale, from 0 (no difficulty), to 3 (severe difficulty). Total scores range from 0-42, with a higher score indicating higher DCM severity.
Measured: Baseline, 6 months, 12 months
Neck Disability Index (NDI)
The NDI is a continuous measure ranging from 0 to 100 with higher scores indicating more severe disability.
Measured: Baseline, 6 months, 12 months
Arm and Shoulder Pain
This will be measured using the 11-point Numerical Rating Scale (NRS), where 0 is 'no pain' and 10 is 'worst possible pain'.
Measured: Baseline, 6 months, 12 months
Upper Extremity Neurologic Function
This will be measured using the grip-and-release test (G\&R test). Participants are asked to grip and release with the fingers as rapidly as possible with the forearm kept in pronation and the wrist in mild extension. The number of complete cycles of movement within 10 seconds are counted.
Measured: Baseline, 6 months, 12 months
Lower Extremity Neurologic Function
This will be measured using the 30-m walking test (30MWT). Participants are asked to walk a straight 30-meter distance as quickly as possible with any normally used walking aids; number of steps and time is recorded.
Measured: Baseline, 6 months, 12 months
Falls
Falls will be assessed using questions one and two of the modified American Geriatric/British Geriatric tool: "How many times have you fallen since the last visit?" and "Since the last visit, did you seek medical care for a fall injury?"
Measured: Baseline, 6 months, 12 months
Dysphagia
Dysphagia will be assessed using the Bazaz Scoring System. This classifies patient reported swallowing difficulty into 4 categories: none, mild, moderate, severe.
Measured: Baseline, 6 months, 12 months
Need for additional cervical spine surgery
This will be assessed and collected from patient self-report and medical records.
Measured: Up to 12 months after the intervention.
Adverse Events
Occurrence of related adverse events will be monitored at every scheduled and unscheduled clinic visit.
Measured: Through study completion, up to 12 months after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study startDec 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Cervical MyelopathyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07358273
- Sponsor's protocol ID
- 5512
- Acronym
- CADET-DCM
- Status last verified
- Dec 2025
- First submitted
- 5 Jan 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conservative Care Versus Decompression Trial for Degenerative Cervical Myelopathy Pilot: A Multicenter Randomized Controlled Feasibility Trial
- ClinicalTrials.gov ID
- NCT07358273
- Acronym / sponsor ID
- CADET-DCM / 5512
- Conditions
- Degenerative Cervical Myelopathy
- Keywords
- myelopathy, spinal cord diseases, surgery, conservative care, spine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 22 Jan 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 study is a pilot randomized clinical trial designed to test whether it is feasible to conduct a larger study comparing two standard treatments for mild degenerative cervical myelopathy (DCM).
The main questions it aims to answer are:
- Can enough participants be recruited and successfully complete follow-up assessments?
- Will participants adhere to their assigned treatment?
Researchers will compare two groups:
- Surgical group: Participants receive decompressive spine surgery (with or without fusion).
- Conservative care group: Participants follow a structured program that includes education, fall prevention strategies, and tailored exercises.
Participants will:
- Complete baseline and follow-up assessments at 6 weeks, 6 months, and 12 months.
- In the surgical group: undergo surgery within 12 weeks of randomization and receive standard post-operative care.
- In the conservative care group: follow a 6-week progressive exercise program and continue self-management strategies.
- Complete a monthly online symptom monitoring questionnaire
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservative Care | Active comparator | Other: Conservative CareStandard of care intervention |
| Surgical Decompression | Active comparator | Procedure: Decompression SurgeryStandard of care intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- Show evidence of spinal cord compression between C2 and T1 on MRI or CT myelography conducted within 2 years of enrollment
- Present with mild DCM defined as a score of 15-17 on the modified Japanese Orthopaedic Association (mJOA) score
Key exclusion criteria (10 listed)
- Clinical suspicion that myelopathic symptoms are exacerbated or caused by another neurologic condition (i.e. amyotrophic lateral sclerosis, multiple sclerosis, syringomyelia, peripheral neuropathy)
- Demonstrate ossification of the posterior longitudinal ligament (OPLL)
- Previous cervical spine surgery
- Report known or suspected tandem symptomatic thoracic or lumbar spinal stenosis
- Present with an acute traumatic spinal cord injury (i.e., central cord syndrome)
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 |
|---|---|---|
| Decompression SurgerySurgical decompression of the cervical spine | Procedure or surgery | Surgical Decompression |
| Conservative CareConservative care Program for cervical myelopathy | Other | Conservative Care |
Primary outcome
Consent proportion
Time frame: Enrollment
Total number of participants randomized/ total number of patients approached
Follow-up completion
Time frame: 6 month follow-up
Number of participants with 6-month follow up completed/ number of participants randomized
Adherence to intervention
Time frame: 6 months after enrollment
Number of participants who proceed with allocated intervention/ number of participants randomized
10 secondary outcomes
Patient-derived Modified Japanese Orthopaedic Association Scale (P-mJOA)
Time frame: Baseline, 6 months, 12 months
Cervical Myelopathy Severity Index (CMSI)
Time frame: Baseline, 6 months, 12 months
Neck Disability Index (NDI)
Time frame: Baseline, 6 months, 12 months
Arm and Shoulder Pain
Time frame: Baseline, 6 months, 12 months
Upper Extremity Neurologic Function
Time frame: Baseline, 6 months, 12 months
Lower Extremity Neurologic Function
Time frame: Baseline, 6 months, 12 months
Falls
Time frame: Baseline, 6 months, 12 months
Dysphagia
Time frame: Baseline, 6 months, 12 months
Need for additional cervical spine surgery
Time frame: Up to 12 months after the intervention.
Adverse Events
Time frame: Through study completion, up to 12 months after intervention.
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 7 Oct 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Decompression Surgery and Conservative Care in people with Degenerative Cervical Myelopathy, run by McMaster University.
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 3 inclusion and 10 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: opening soon, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Sydney Research Coordinator (905-521-2100 ext. 44848, maclesd@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consent proportion (time frame: Enrollment). 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?
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 7 Oct 2026.