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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Decompression Surgery

    Procedure/Surgery

    Surgical decompression of the cervical spine

  • Conservative Care

    Other intervention

    Conservative care Program for cervical myelopathy

Treatment groups

56 Participants
are divided into 2 treatment groups
Group A: Conservative CareActive comparator 1 intervention
Group B: Surgical DecompressionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Consent proportion

Total number of participants randomized/ total number of patients approached

Time frame
Enrollment
2

Follow-up completion

Number of participants with 6-month follow up completed/ number of participants randomized

Time frame
6 month follow-up
3

Adherence to intervention

Number of participants who proceed with allocated intervention/ number of participants randomized

Time frame
6 months after enrollment

Secondary outcomes

1

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.

Time frame
Baseline, 6 months, 12 months
2

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.

Time frame
Baseline, 6 months, 12 months
3

Neck Disability Index (NDI)

The NDI is a continuous measure ranging from 0 to 100 with higher scores indicating more severe disability.

Time frame
Baseline, 6 months, 12 months
4

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'.

Time frame
Baseline, 6 months, 12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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