Conservative Care Versus Decompression Trial for Degenerative Cervical Myelopathy Pilot

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMcMaster University

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Decompression Surgery
  • Conservative Care

Treatment groups

56 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators