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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Degenerative Cervical Myelopathy
• Intervention / Treatment: Other: Conservative Care; Procedure: Decompression Surgery

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sydney Research Coordinator; Phone Number: 44848 905-521-2100; Email: maclesd@mcmaster.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conservative Care; Standard of care intervention	Other: Conservative Care; Conservative care Program for cervical myelopathy
Active Comparator: Surgical Decompression; Standard of care intervention	Procedure: Decompression Surgery; Surgical decompression of the cervical spine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Consent proportion	Total number of participants randomized/ total number of patients approached	Enrollment
Follow-up completion	Number of participants with 6-month follow up completed/ number of participants randomized	6 month follow-up
Adherence to intervention	Number of participants who proceed with allocated intervention/ number of participants randomized	6 months after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-derived Modified Japanese Orthopaedic Association Scale (P-mJOA)	Patient reported outcome assessing (i) upper extremity sensation, (ii) upper extremity motor function, (iii) lower extremity motor function, and (iv) sphincter function. It is used to grade DCM severity, and scored between 0 and 18. Scores of 18 indicate no dysfunction, 15 to 17 indicate mild DCM, 12 to 14 indicate moderate DCM, 11 and lower indicating severe DCM.	Baseline, 6 months, 12 months
Cervical Myelopathy Severity Index (CMSI)	The Cervical Myelopathy Severity Index (CSMI) assesses neurological function. It is a patient-completed 14-item measure for patients with DCM to evaluate symptom severity and functional limitations. Items span dexterity, balance/gait, pain, sensory impairment, and sphincter dysfunction. Each item is rated on a 4-point scale, from 0 (no difficulty), to 3 (severe difficulty). Total scores range from 0-42, with a higher score indicating higher DCM severity.	Baseline, 6 months, 12 months
Neck Disability Index (NDI)	The NDI is a continuous measure ranging from 0 to 100 with higher scores indicating more severe disability.	Baseline, 6 months, 12 months
Arm and Shoulder Pain	This will be measured using the 11-point Numerical Rating Scale (NRS), where 0 is 'no pain' and 10 is 'worst possible pain'.	Baseline, 6 months, 12 months
Upper Extremity Neurologic Function	This will be measured using the grip-and-release test (G&R test). Participants are asked to grip and release with the fingers as rapidly as possible with the forearm kept in pronation and the wrist in mild extension. The number of complete cycles of movement within 10 seconds are counted.	Baseline, 6 months, 12 months
Lower Extremity Neurologic Function	This will be measured using the 30-m walking test (30MWT). Participants are asked to walk a straight 30-meter distance as quickly as possible with any normally used walking aids; number of steps and time is recorded.	Baseline, 6 months, 12 months
Falls	Falls will be assessed using questions one and two of the modified American Geriatric/British Geriatric tool: "How many times have you fallen since the last visit?" and "Since the last visit, did you seek medical care for a fall injury?"	Baseline, 6 months, 12 months
Dysphagia	Dysphagia will be assessed using the Bazaz Scoring System. This classifies patient reported swallowing difficulty into 4 categories: none, mild, moderate, severe.	Baseline, 6 months, 12 months
Need for additional cervical spine surgery	This will be assessed and collected from patient self-report and medical records.	Up to 12 months after the intervention.
Adverse Events	Occurrence of related adverse events will be monitored at every scheduled and unscheduled clinic visit.	Through study completion, up to 12 months after intervention.

Collaborators and Investigators

• Sponsor: McMaster University

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: January 5, 2026
• First Submitted That Met QC Criteria: January 13, 2026
• First Posted (Actual): January 22, 2026

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: surgery; spine; myelopathy; spinal cord diseases; conservative care
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Therapeutics; Surgical Procedures, Operative; Neurosurgical Procedures; Orthopedic Procedures; Decompression, Surgical; Laminectomy
• Other Study ID Numbers: 5512

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No