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NCT Number: NCT06781658

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

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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Key information

Conditions

Degenerative Cervical Myelopathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

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.

Primary outcomes

  1. Incidence of mild stable DCM

    Time frame: Baseline

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

  2. 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.

  3. Participant recruitment rate

    Time frame: Baseline

    The number of participants recruited per month

  4. Participant adherence to the intervention

    Time frame: 12 weeks

    The number of scheduled sessions attended by the participants.

  5. Clinician adherence to the intervention

    Time frame: 12 weeks

    The number of core intervention components included in each treatment session

  6. Acceptability of the intervention to the participants and clinicians

    Time frame: 12 weeks

    Semi-structured interviews

  7. Burden of measurement tool completion

    Time frame: 12 weeks

    Semi structured interview

  8. Participant retention rate

    Time frame: 12 weeks

    Loss to follow up rate and reasons for loss to follow up

Secondary outcomes

  1. Physical component score of the short form (SF) 36

    Time frame: Baseline and 12 weeks

    Physical functioning

  2. Modified Japanese Orthopaedic association index (mJOA)

    Time frame: Baseline and 12 weeks

    Myelopathy severity scale

  3. Neck disability index

    Time frame: Baseline and 12 weeks

    Neck pain related disability

  4. Spinal adverse events severity scale

    Time frame: 12 weeks

    Adverse events

Study contacts

Contact information is provided by the study sponsor or research team.

Caroline Treanor, Bsc Msc

CONTACT

[email protected]

01 809 3000 ext. 2536

Sponsors and collaborators

Lead sponsor

Royal College of Surgeons, Ireland

Other

Registry information

Official study 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.

Acronym: RehabmildDCM

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 17, 2025
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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