NCT07358273

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
13mo left

Started Feb 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress20%
Feb 2026Jun 2027

First Submitted

Initial submission to the registry

January 5, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 22, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

January 22, 2026

Status Verified

December 1, 2025

Enrollment Period

1.3 years

First QC Date

January 5, 2026

Last Update Submit

January 13, 2026

Conditions

Degenerative Cervical Myelopathy

Keywords

myelopathyspinal cord diseasessurgeryconservative carespine

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (10)

  • Patient-derived Modified Japanese Orthopaedic Association Scale (P-mJOA)

    Baseline, 6 months, 12 months

  • Cervical Myelopathy Severity Index (CMSI)

    Baseline, 6 months, 12 months

  • Neck Disability Index (NDI)

    Baseline, 6 months, 12 months

  • Arm and Shoulder Pain

    Baseline, 6 months, 12 months

  • Upper Extremity Neurologic Function

    Baseline, 6 months, 12 months

  • +5 more secondary outcomes

Study Arms (2)

Conservative Care

ACTIVE COMPARATOR

Standard of care intervention

Other: Conservative Care

Surgical Decompression

ACTIVE COMPARATOR

Standard of care intervention

Procedure: Decompression Surgery

Interventions

Decompression SurgeryPROCEDURE

Surgical decompression of the cervical spine

Surgical Decompression
Conservative CareOTHER

Conservative care Program for cervical myelopathy

Conservative Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Spinal Cord Diseases

Interventions

Laminectomy

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Orthopedic ProceduresTherapeuticsDecompression, SurgicalSurgical Procedures, OperativeNeurosurgical Procedures

Central Study Contacts

Sydney Research Coordinator

CONTACT

905-521-2100maclesd@mcmaster.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2026

First Posted

January 22, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

January 22, 2026

Record last verified: 2025-12