Conservative Care Versus Decompression Trial for Degenerative Cervical Myelopathy Pilot (CADET-DCM)

McMaster University

Status: Not yet enrolling

Conditions: Degenerative Cervical Myelopathy

Treatments: Procedure: Decompression Surgery; Other: Conservative Care

Study type: Interventional

Funder types: Other

Identifiers

NCT07358273

5512

Details and patient eligibility

About

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

Enrollment: 56 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Conservative Care

Active Comparator group

Description:

Standard of care intervention

Treatment:

Other: Conservative Care

Surgical Decompression

Active Comparator group

Description:

Standard of care intervention

Treatment:

Procedure: Decompression Surgery