Rehab in Mild Stable DCM: Feasibility RCT Comparing Structured Rehabilitation to Clinical Surveillance

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRoyal College of Surgeons, Ireland

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 volunteers

Qualifiers

• 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

Design model

Parallel

Treatments tested in this trial

  • Structured rehabilitation intervention

    Other 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).

  • Clinical Surveillance

    Other intervention

    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.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Structured rehabilitation interventionExperimental treatment 1 intervention
Group B: Clinical surveillanceActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of mild stable DCM

Number of people with mild stable DCM during the study period/ number of NP seen.

Time frame
Baseline
2

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
3

Participant recruitment rate

The number of participants recruited per month

Time frame
Baseline
4

Participant adherence to the intervention

The number of scheduled sessions attended by the participants.

Time frame
12 weeks

Secondary outcomes

1

Physical component score of the short form (SF) 36

Physical functioning

Time frame
Baseline and 12 weeks
2

Modified Japanese Orthopaedic association index (mJOA)

Myelopathy severity scale

Time frame
Baseline and 12 weeks
3

Neck disability index

Neck pain related disability

Time frame
Baseline and 12 weeks
4

Spinal adverse events severity scale

Adverse events

Time frame
12 weeks

Other outcomes

Sponsors and contacts

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