About this trial
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
This trial does not accept healthy volunteersQualifiers
• 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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Structured rehabilitation intervention
Other interventionParticipants will be prescribed a multi-component SRI which will include education, cervical range of motion exercises, progressive neck strengthening exercises, individualised scapular and upper limb strengthening, task specific hand function training and a physical activity behavioural change intervention. The TIDieR checklist has been used to provide a comprehensive description of this complex intervention. (17).
Clinical Surveillance
Other interventionParticipants assigned to the clinical surveillance control group will be invited to attend a single, one to one education session which will be supplemented with a written patient information booklet after which they will be scheduled for a 12 week follow up.
Treatment groups
Trial outcomes
Primary outcomes
Incidence of mild stable DCM
Number of people with mild stable DCM during the study period/ number of NP seen.
Number of people with mild stable DCM who are willing to participate but do not reach the eligibility criteria
The number of people with mild stable DCM over the study period- the number of people with mild stable DCM who are eligible to participate in the study.
Participant recruitment rate
The number of participants recruited per month
Participant adherence to the intervention
The number of scheduled sessions attended by the participants.
Secondary outcomes
Physical component score of the short form (SF) 36
Physical functioning
Modified Japanese Orthopaedic association index (mJOA)
Myelopathy severity scale
Neck disability index
Neck pain related disability
Spinal adverse events severity scale
Adverse events
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: