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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:
Researchers will compare two groups:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conservative Care | Active Comparator | Standard of care intervention |
|
| Surgical Decompression | Active Comparator | Standard of care intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decompression Surgery | Procedure | Surgical decompression of the cervical spine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Consent proportion | Total number of participants randomized/ total number of patients approached | Enrollment |
| Follow-up completion | Number of participants with 6-month follow up completed/ number of participants randomized | 6 month follow-up |
| Adherence to intervention | Number of participants who proceed with allocated intervention/ number of participants randomized | 6 months after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sydney Research Coordinator | Contact | 905-521-2100 | 44848 | maclesd@mcmaster.ca |
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| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D007796 | Laminectomy |
| ID | Term |
|---|---|
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
| D019299 | Decompression, Surgical |
| D013514 | Surgical Procedures, Operative |
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| Conservative Care |
| Other |
Conservative care Program for cervical myelopathy |
|
| 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. | 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. | 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'. | 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. | 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. | 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?" | 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. | Baseline, 6 months, 12 months |
| Need for additional cervical spine surgery | This will be assessed and collected from patient self-report and medical records. | Up to 12 months after the intervention. |
| Adverse Events | Occurrence of related adverse events will be monitored at every scheduled and unscheduled clinic visit. | Through study completion, up to 12 months after intervention. |
| D019635 | Neurosurgical Procedures |