Degenerative Cervical MyelopathyRehabmildDCMNCT06781658
Rehab in Mild Stable DCM: Feasibility RCT Comparing Structured Rehabilitation to Clinical Surveillance
A study testing Structured rehabilitation intervention and Clinical Surveillance in people with Degenerative Cervical Myelopathy, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Cervical Myelopathy
- What is being tested?
- Structured rehabilitation intervention and Clinical Surveillance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIreland
- Study dates
- 13 Jan 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ireland1 site
Beaumont Hospital
Dublin
Caroline Treanor, Bsc MSC, 018093000 ext. 2536, carolinetreanor@beaumont.ie
About this study
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.
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.
- Conditions
- Degenerative Cervical Myelopathy
- Being tested
- Structured rehabilitation intervention, Clinical Surveillance
- Keywords
- Degenerative cervical myelopathy, Mild DCM, Rehabilitation, clinical Surveillance, Feasibility RCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured rehabilitation interventionOther
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).
Clinical SurveillanceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Structured rehabilitation intervention |
| 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. Receives: Other: Clinical Surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of mild stable DCM
Number of people with mild stable DCM during the study period/ number of NP seen.
Measured: 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.
Measured: Baseline
Participant recruitment rate
The number of participants recruited per month
Measured: Baseline
Participant adherence to the intervention
The number of scheduled sessions attended by the participants.
Measured: 12 weeks
Clinician adherence to the intervention
The number of core intervention components included in each treatment session
Measured: 12 weeks
Acceptability of the intervention to the participants and clinicians
Semi-structured interviews
Measured: 12 weeks
Burden of measurement tool completion
Semi structured interview
Measured: 12 weeks
Participant retention rate
Loss to follow up rate and reasons for loss to follow up
Measured: 12 weeks
Secondary outcomes (4)
Physical component score of the short form (SF) 36
Physical functioning
Measured: Baseline and 12 weeks
Modified Japanese Orthopaedic association index (mJOA)
Myelopathy severity scale
Measured: Baseline and 12 weeks
Neck disability index
Neck pain related disability
Measured: Baseline and 12 weeks
Spinal adverse events severity scale
Adverse events
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start13 Jan 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Cervical MyelopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ciaran Bolger, MD PhD, Principal investigator, Royal College of Surgeons
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06781658
- Sponsor's protocol ID
- 23-172
- Acronym
- RehabmildDCM
- Status last verified
- Jan 2025
- First submitted
- 6 Jan 2025
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06781658
- Acronym / sponsor ID
- RehabmildDCM / 23-172
- Conditions
- Degenerative Cervical Myelopathy
- Keywords
- Degenerative cervical myelopathy, Mild DCM, Rehabilitation, clinical Surveillance, Feasibility RCT
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Royal College of Surgeons, IrelandUniversity, hospital or other
- Study start
- 13 Jan 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 17 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Structured rehabilitation intervention | Experimental | Other: Structured rehabilitation interventionThe 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 | Other: Clinical SurveillanceParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- • 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured rehabilitation 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). | Other | Structured rehabilitation intervention |
| Clinical SurveillanceParticipants 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. | Other | Clinical surveillance |
Primary outcome
Incidence of mild stable DCM
Time frame: 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
Time frame: 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
Time frame: Baseline
The number of participants recruited per month
Participant adherence to the intervention
Time frame: 12 weeks
The number of scheduled sessions attended by the participants.
Clinician adherence to the intervention
Time frame: 12 weeks
The number of core intervention components included in each treatment session
Acceptability of the intervention to the participants and clinicians
Time frame: 12 weeks
Semi-structured interviews
Burden of measurement tool completion
Time frame: 12 weeks
Semi structured interview
Participant retention rate
Time frame: 12 weeks
Loss to follow up rate and reasons for loss to follow up
4 secondary outcomes
Physical component score of the short form (SF) 36
Time frame: Baseline and 12 weeks
Modified Japanese Orthopaedic association index (mJOA)
Time frame: Baseline and 12 weeks
Neck disability index
Time frame: Baseline and 12 weeks
Spinal adverse events severity scale
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ciaran Bolger, MD PhD principal investigator
Royal College of Surgeons
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured rehabilitation intervention and Clinical Surveillance in people with Degenerative Cervical Myelopathy, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caroline Treanor, Bsc Msc (01 809 3000 ext. 2536, carolinetreanor22@rcsi.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of mild stable DCM (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.