Clinical trial NCT06781658: Rehab in Mild Stable DCM: Feasibility RCT Comparing Structured Rehabilitation to Clinical Surveillance
Official title: Rehab in Mild DCM: Study Protocol for a Feasibility Randomised Controlled Trial to Compare the Effectiveness of a Structured Rehabilitation Intervention to Clinical Surveillance in People With Mild Stable Degenerative Cervical Myelopathy.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Degenerative Cervical Myelopathy
Keywords: Degenerative cervical myelopathy
Mild DCM
Rehabilitation
clinical Surveillance
Feasibility RCT
Lead sponsor: Royal College of Surgeons, Ireland
Sponsor class: OTHER
First posted: 2025-01-17
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this feasibility RCT is to establish the feasibility of undertaking a RCT investigating the effectiveness of a multi component structured rehabilitation intervention aiming at reducing physical disability in people with mild stable Degenerative Cervical Myelopathy. The main question it will answer are what is the incidence of mild stable DCM in the neurosurgical OPD clinics, what is the eligibility rate and participate rate of those eligible. It will also investigate the acceptability of the intervention to both participants and clinicians and participant retention.

Researchers will compare a structured rehabilitation intervention to clinical surveillance. The structured rehabilitation intervention will include education, a physical activity behavioural change intervention, cervical range of motion exercises, neck, upper limb and scapular strengthening exercises and task specific hand function training.


Eligibility criteria: Inclusion Criteria:

* • Diagnosis of DCM (Clinical symptom of DCM +/- Upper motor neuron sign + imaging evidence of cervical cord compression). Diagnosis will be confirmed by a consultant neurosurgeon (19).

  * Modified Japanese Orthopaedic assessment (mJOA) score of 15-17, indicating mild DCM. The mJOA is a clinician administered validated measure of DCM severity (20)
  * Adequate comprehension of English to understand the purpose of the study and give written informed consent

Exclusion Criteria:

* Patient or surgeon preference for urgent surgical decompression for progressive DCM, motor radiculopathy or severe unrelenting radicular arm pain or significant risk factors for progression including co-existing cervical radiculopathy and circumferential cord compression.

  * Diagnosis of other neurological condition that could confound assessment.
  * Involvement in another clinical study or trial
  * Pregnancy
  * If the participant is unable to commit to a 12-week programme of up to 10 sessions of supervised rehabilitation and participating in a regular home exercise programme for the duration of the study.

Primary outcomes:
measure: Incidence of mild stable DCM
timeFrame: Baseline
measure: Number of people with mild stable DCM who are willing to participate but do not reach the eligibility criteria
timeFrame: Baseline
measure: Participant recruitment rate
timeFrame: Baseline
measure: Participant adherence to the intervention
timeFrame: 12 weeks
measure: Clinician adherence to the intervention
timeFrame: 12 weeks
measure: Acceptability of the intervention to the participants and clinicians
timeFrame: 12 weeks
measure: Burden of measurement tool completion
timeFrame: 12 weeks
measure: Participant retention rate
timeFrame: 12 weeks
Secondary outcomes:
measure: Physical component score of the short form (SF) 36
timeFrame: Baseline and 12 weeks
measure: Modified Japanese Orthopaedic association index (mJOA)
timeFrame: Baseline and 12 weeks
measure: Neck disability index
timeFrame: Baseline and 12 weeks
measure: Spinal adverse events severity scale
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Beaumont Hospital
Study officials:
affiliation: Royal College of Surgeons
name: Ciaran Bolger, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: