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Clinical Trials/NCT07358273
NCT07358273Not yet recruitingNot Applicable

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

McMaster University0 sites56 target enrollmentStarted: February 1, 2026Last updated:
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Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
56
Study OverviewStudy DesignEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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