Degenerative Cervical Myelopathy
Conditions
Keywords
myelopathy, spinal cord diseases, surgery, conservative care, spine
Brief 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). 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
Interventions
PROCEDUREDecompression Surgery
Surgical decompression of the cervical spine
OTHERConservative Care
Conservative care Program for cervical myelopathy
Sponsors
McMaster University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Consent proportion | Enrollment | Total number of participants randomized/ total number of patients approached |
| Follow-up completion | 6 month follow-up | Number of participants with 6-month follow up completed/ number of participants randomized |
| Adherence to intervention | 6 months after enrollment | Number of participants who proceed with allocated intervention/ number of participants randomized |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-derived Modified Japanese Orthopaedic Association Scale (P-mJOA) | Baseline, 6 months, 12 months | 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. |
| Cervical Myelopathy Severity Index (CMSI) | Baseline, 6 months, 12 months | 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. |
| Neck Disability Index (NDI) | Baseline, 6 months, 12 months | The NDI is a continuous measure ranging from 0 to 100 with higher scores indicating more severe disability. |
| Arm and Shoulder Pain | Baseline, 6 months, 12 months | This will be measured using the 11-point Numerical Rating Scale (NRS), where 0 is 'no pain' and 10 is 'worst possible pain'. |
| Upper Extremity Neurologic Function | Baseline, 6 months, 12 months | 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. |
| Lower Extremity Neurologic Function | Baseline, 6 months, 12 months | 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. |
| Falls | Baseline, 6 months, 12 months | 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?" |
| Dysphagia | Baseline, 6 months, 12 months | Dysphagia will be assessed using the Bazaz Scoring System. This classifies patient reported swallowing difficulty into 4 categories: none, mild, moderate, severe. |
| Need for additional cervical spine surgery | Up to 12 months after the intervention. | This will be assessed and collected from patient self-report and medical records. |
| Adverse Events | Through study completion, up to 12 months after intervention. | Occurrence of related adverse events will be monitored at every scheduled and unscheduled clinic visit. |
Contacts
CONTACTSydney Research Coordinator
Outcome results
None listed