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

Royal College of Surgeons, Ireland

Status: Not yet enrolling

Conditions: Degenerative Cervical Myelopathy

Treatments: Other: Structured rehabilitation intervention; Other: Clinical Surveillance

Study type: Interventional

Funder types: Other

Identifiers

NCT06781658

23-172

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Structured rehabilitation intervention

Experimental group

Description:

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.

Treatment:

Other: Structured rehabilitation intervention

Clinical surveillance

Active Comparator group

Description:

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:

Other: Clinical Surveillance