Targeting patient recovery priorities in degenerative cervical myelopathy: design and rationale for the RECEDE-Myelopathy trial—study protocol

BMJ Open, 2023 · DOI: 10.1136/bmjopen-2022-061294 · Published: January 1, 2023

Spinal Cord Injury Neurology Research Methodology & Design

Simple Explanation

Degenerative cervical myelopathy (DCM) is a condition where the spinal cord is compressed in the neck due to age-related changes. The RECEDE-Myelopathy trial aims to test if the drug Ibudilast can help improve recovery after surgery for DCM. The study will involve patients taking either Ibudilast or a placebo before and after surgery, and researchers will measure their pain and physical function to see if Ibudilast makes a difference. This trial is unique because it focuses on what matters most to patients with DCM: reducing pain and improving hand and walking function.

Study Duration

Maximum of 34 weeks

Participants

Adults with DCM, who have a modified Japanese Orthopaedic Association (mJOA) score 8–14 inclusive and are scheduled for their first decompressive surgery

Evidence Level

Not specified

Key Findings

1
The trial will assess whether Ibudilast can improve pain or physical function in patients undergoing surgery for DCM.
2
The study design includes two coprimary endpoints: pain and physical function, reflecting patient priorities.
3
The trial will also explore objective findings, validated questionnaires, and patient-reported outcomes.

Research Summary

The RECEDE-Myelopathy trial will evaluate Ibudilast as an adjuvant treatment to improve recovery after surgical decompression in DCM. This is the first regenerative medicine trial in DCM, directly targeting recovery priorities identified by sufferers. The trial will involve patients taking Ibudilast or a placebo, with outcomes measured at 6 months after surgery.

Practical Implications

Potential New Treatment

If successful, RECEDE-Myelopathy could pave the way for the first evidence-based non-surgical adjuvant treatment for DCM.

Improved Patient Outcomes

The trial targets the recovery priorities of DCM patients, potentially leading to improved pain management and limb function.

Standardized Assessment

The trial will help standardize assessment and monitoring across study centers, promoting the implementation of international guidelines.

Study Limitations

1
Close patient follow-up and rigorous screening are needed.
2
Additional blood tests are required to comply with drug monitoring and assessments.
3
The study excludes patients with several comorbidities or previous surgeries for DCM, limiting generalizability.

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Targeting patient recovery priorities in degenerative cervical myelopathy: design and rationale for the RECEDE-­Myelopathy trial—study protocol

Simple Explanation

Key Findings

Research Summary

Practical Implications

Potential New Treatment

Improved Patient Outcomes

Standardized Assessment

Study Limitations

Your Feedback

Was this summary helpful?

Targeting patient recovery priorities in degenerative cervical myelopathy: design and rationale for the RECEDE-­Myelopathy trial—study protocol

Simple Explanation

Key Findings

Research Summary

Practical Implications

Potential New Treatment

Improved Patient Outcomes

Standardized Assessment

Study Limitations

Your Feedback

Was this summary helpful?

Targeting patient recovery priorities in degenerative cervical myelopathy: design and rationale for the RECEDE-Myelopathy trial—study protocol

Targeting patient recovery priorities in degenerative cervical myelopathy: design and rationale for the RECEDE-Myelopathy trial—study protocol