Degenerative Cervical Myelopathy
Conditions
Keywords
Degenerative cervical myelopathy, Mild DCM, Rehabilitation, clinical Surveillance, Feasibility RCT
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.
Interventions
OTHERStructured rehabilitation intervention
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.
Sponsors
Royal College of Surgeons, Ireland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Every participant will have a unique identifier. The outcome assessors will be blinded to group allocation. Clinicians delivering the interventions and trial participants will not be blinded to group allocations due to the nature of the intervention (56). Participants will be asked in advance of attending for their 12 week follow up not to disclose their group allocation with the outcome assessor. Data analysts will be blinded to group allocation. Unblinding will only occur in exceptional circumstances when knowledge of the group allocation is essential for further management of the participant (57).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant adherence to the intervention | 12 weeks | The number of scheduled sessions attended by the participants. |
| Participant retention rate | 12 weeks | Loss to follow up rate and reasons for loss to follow up |
| Incidence of mild stable DCM | Baseline | 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 | Baseline | 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 | Baseline | The number of participants recruited per month |
| Clinician adherence to the intervention | 12 weeks | The number of core intervention components included in each treatment session |
| Acceptability of the intervention to the participants and clinicians | 12 weeks | Semi-structured interviews |
| Burden of measurement tool completion | 12 weeks | Semi structured interview |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Japanese Orthopaedic association index (mJOA) | Baseline and 12 weeks | Myelopathy severity scale |
| Neck disability index | Baseline and 12 weeks | Neck pain related disability |
| Spinal adverse events severity scale | 12 weeks | Adverse events |
| Physical component score of the short form (SF) 36 | Baseline and 12 weeks | Physical functioning |
Countries
Ireland
Contacts
Primary ContactCaroline Treanor, Bsc Msc
Outcome results
None listed