Trial to investigate which treatment is preferred for mild symptoms due to stenosis (narrowing) in the cervical spinal canal: conservative treatment or surgery
Not Applicable
- Conditions
- Cervical spondylotic myelopathyNervous System Diseases
- Registration Number
- ISRCTN16571565
- Lead Sponsor
- Radboud University Nijmegen Medical Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
1. Adult patients
2. Signs and symptoms of cervical myelopathy
3. Radiologic signs of degenerative compressive cervical myelopathy
4. mJOA =15
Exclusion Criteria
1. Non-fluent in the Dutch language
2. Soft disc as causative pathological mechanism
3. Coexisting diseases that cause signs and symptoms interfering with those of CSM, e.g., plexopathy, cerebrovascular incident, polyneuropathy due to diabetes mellitus, etc
4. Alcohol abuse (more than two units daily)
5. mJOA <15
6. Previous history of neck surgery
7. Non-degenerative CSM
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Functionality of the hand is measured using the 15-s grip and release test at baseline, 6 weeks, 3, 12 and 24 months
- Secondary Outcome Measures
Name Time Method <br> 1. Disability is measured by the modified Japanese Orthopaedic Association (mJOA) score at baseline, 3, 12 and 24 months<br> 2. Neck pain and disability due to neck related problems is measured by the neck disability index (NDI) at baseline, 3, 12 and 24 months<br> 3. Quality of life is assessed by the EQ-5D-5L at baseline, 3, 12 and 24 months<br> 4. Complications are registered in the early postoperative stage (6 weeks)<br> 5. Healthcare resource use is measured by the iMTA Medical Consumption Questionnaire (iMCQ) at baseline, 3, 12 and 24 months<br> 6. Productivity loss is assessed by the iMTA Productivity Cost Questionnaire (iPCQ) at baseline, 3, 12 and 24 months<br>