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Not yet recruiting NCT07358273

Conservative Care Versus Decompression Trial for Degenerative Cervical Myelopathy Pilot

No phase Interventional Degenerative Cervical Myelopathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Decompression Surgery, Conservative Care.
Who it may be relevant to
Registry conditions: Degenerative Cervical Myelopathy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Conservative Care Versus Decompression Trial for Degenerative Cervical Myelopathy Pilot: A Multicenter Randomized Controlled Feasibility Trial

Overview

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

  • Procedure Decompression Surgery
    Surgical decompression of the cervical spine
  • Other Conservative Care
    Conservative care Program for cervical myelopathy

Primary outcome measures

  • Consent proportion [Time frame: Enrollment]
  • Follow-up completion [Time frame: 6 month follow-up]
  • Adherence to intervention [Time frame: 6 months after enrollment]
Secondary outcome measures (10)
  • 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07358273 · 5512

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗