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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
24
Participants 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).
Participants 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.
Beaumont Hospital
Dublin, Ireland
Incidence of mild stable DCM
Number of people with mild stable DCM during the study period/ number of NP seen.
Time frame: Baseline
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.
Time frame: Baseline
Participant recruitment rate
The number of participants recruited per month
Time frame: Baseline
Participant adherence to the intervention
The number of scheduled sessions attended by the participants.
Time frame: 12 weeks
Clinician adherence to the intervention
The number of core intervention components included in each treatment session
Time frame: 12 weeks
Acceptability of the intervention to the participants and clinicians
Semi-structured interviews
Time frame: 12 weeks
Burden of measurement tool completion
Semi structured interview
Time frame: 12 weeks
Participant retention rate
Loss to follow up rate and reasons for loss to follow up
Time frame: 12 weeks
Physical component score of the short form (SF) 36
Physical functioning
Time frame: Baseline and 12 weeks
Modified Japanese Orthopaedic association index (mJOA)
Myelopathy severity scale
Time frame: Baseline and 12 weeks
Neck disability index
Neck pain related disability
Time frame: Baseline and 12 weeks
Spinal adverse events severity scale
Adverse events
Time frame: 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.