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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Structured rehabilitation intervention | Experimental | The SRI 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. |
|
| Clinical surveillance | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Structured rehabilitation intervention | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of mild stable DCM | Number of people with mild stable DCM during the study period/ number of NP seen. | 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. | Baseline |
| Participant recruitment rate | The number of participants recruited per month | Baseline |
| Participant adherence to the intervention | The number of scheduled sessions attended by the participants. | 12 weeks |
| Clinician adherence to the intervention | The number of core intervention components included in each treatment session | 12 weeks |
| Acceptability of the intervention to the participants and clinicians | Semi-structured interviews | 12 weeks |
| Burden of measurement tool completion | Semi structured interview | 12 weeks |
| Participant retention rate |
| Measure | Description | Time Frame |
|---|---|---|
| Physical component score of the short form (SF) 36 | Physical functioning | Baseline and 12 weeks |
| Modified Japanese Orthopaedic association index (mJOA) | Myelopathy severity scale |
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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).
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caroline Treanor, Bsc Msc | Contact | 01 809 3000 | 2536 | carolinetreanor22@rcsi.ie |
| Name | Affiliation | Role |
|---|---|---|
| Ciaran Bolger, MD PhD | Royal College of Surgeons | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beaumont Hospital | Dublin | Ireland |
|
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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).
|
| Clinical Surveillance | Other | 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. |
|
Loss to follow up rate and reasons for loss to follow up
| 12 weeks |
| Baseline and 12 weeks |
| Neck disability index | Neck pain related disability | Baseline and 12 weeks |
| Spinal adverse events severity scale | Adverse events | 12 weeks |