Trial to investigate which treatment is preferred for mild symptoms due to stenosis (narrowing) in the cervical spinal canal: conservative treatment or surgery

COnservative or SUrgical treatment for mild cervical spondylotic myelopathy: a multi-center randomized controlled trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16571565

Enrollment

Registered

2022-02-01

Start date

2022-12-01

Completion date

Unknown

Last updated

2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical spondylotic myelopathy Nervous System Diseases

Interventions

For the treatment group allocation, a variable block randomization method is chosen. For this purpose, an online data system, CastorEDC (EU HQ, Amsterdam, the Netherlands), is used. Variable block siz

therefore, the surgical approach is at the discretion of the treating surgeon. Conservative treatment: Supervised conservative therapy will also be used. The patients

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Functionality of the hand is measured using the 15-s grip and release test at baseline, 6 weeks, 3, 12 and 24 months	—

Secondary

Measure	Time frame
1. Disability is measured by the modified Japanese Orthopaedic Association (mJOA) score at baseline, 3, 12 and 24 months 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 3. Quality of life is assessed by the EQ-5D-5L at baseline, 3, 12 and 24 months 4. Complications are registered in the early postoperative stage (6 weeks) 5. Healthcare resource use is measured by the iMTA Medical Consumption Questionnaire (iMCQ) at baseline, 3, 12 and 24 months 6. Productivity loss is assessed by the iMTA Productivity Cost Questionnaire (iPCQ) at baseline, 3, 12 and 24 months	—

Measure

Time frame

1. Disability is measured by the modified Japanese Orthopaedic Association (mJOA) score at baseline, 3, 12 and 24 months 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 3. Quality of life is assessed by the EQ-5D-5L at baseline, 3, 12 and 24 months 4. Complications are registered in the early postoperative stage (6 weeks) 5. Healthcare resource use is measured by the iMTA Medical Consumption Questionnaire (iMCQ) at baseline, 3, 12 and 24 months 6. Productivity loss is assessed by the iMTA Productivity Cost Questionnaire (iPCQ) at baseline, 3, 12 and 24 months

—

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026