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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Decompression Surgery
Procedure/SurgerySurgical decompression of the cervical spine
Conservative Care
Other interventionConservative care Program for cervical myelopathy
Treatment groups
Trial outcomes
Primary outcomes
Consent proportion
Total number of participants randomized/ total number of patients approached
Follow-up completion
Number of participants with 6-month follow up completed/ number of participants randomized
Adherence to intervention
Number of participants who proceed with allocated intervention/ number of participants randomized
Secondary outcomes
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.
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.
Neck Disability Index (NDI)
The NDI is a continuous measure ranging from 0 to 100 with higher scores indicating more severe disability.
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'.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: