Prospective Randomized Control Trial to Compare the Role of Injection Cerebrolysin for 10 Days Duration Against Placebo in Operated Cases of Degenerative Cervical Myelopathy.
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2023-03
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Abstract
Study design
Prospective randomized control trial.Objective
To analyze outcomes following the injection of cerebrolysin in surgically treated patients with degenerative cervical myelopathy (DCM).Summary of background data
Previous research has concluded that superior functional outcomes are achieved with the use of cerebrolysin in surgically treated patients of DCM for 21 days. Our study has been conducted to analyze the use of this drug for a shorter duration (10 days) and compare its clinical efficacy.Methods
Ninety operated cases of mild to severe DCM were randomized into two groups. Sixty patients received the injection Cerebrolysin for 10 days postoperatively. The remaining 30 patients received a placebo. Functional outcomes were measured using modified Japanese Orthopaedic Association (mJOA) scores and visual analogue scale (VAS). The American Spinal Injury Association (ASIA) scale was used to document neurological recovery. Hand function was assessed by measuring the grip strength and the upper limb function score the upper extremity motor mJOA plus upper extremity sensory mJOA score. Assessments were performed and preoperatively and postoperatively and at one-month, three-month, six-month, and one-year following surgery.Results
Preoperative mJOA and VAS scores were comparable in both groups ( P >0.05). Both groups experienced an improvement in mJOA and VAS scores at all time-points during follow-up as compared with preoperative scores. However, the cerebrolysin group demonstrated significantly greater mJOA scores (16.37±1) when compared with the placebo (15.2±1.8) at one-year follow-up ( P <0.0001). Neurological improvement with cerebrolysin therapy was also superior ( P =0.04). No significant adverse reactions were documented.Conclusion
Injection cerebrolysin, when administered for 10 days postoperatively, can result in significantly greater neurological improvement and hand function in patients with DCM who also receive surgery.Type
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Sharma, Ayush, Harsh Agrawal, Atif Naseem, Nandan Marathe, Komalchand Gajbhiye, Santhoshkumar Subramanian and Brett Rocos (2023). Prospective Randomized Control Trial to Compare the Role of Injection Cerebrolysin for 10 Days Duration Against Placebo in Operated Cases of Degenerative Cervical Myelopathy. Spine, 48(5). pp. 295–300. 10.1097/brs.0000000000004542 Retrieved from https://hdl.handle.net/10161/29686.
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Brett Rocos
I joined the team at Duke University Health from London, UK, where I was a Consultant Adult and Paediatric Spine Surgeon at Barts Health NHS Trust and Honorary Consultant Senior Lecturer at Queen Mary University of London. I completed my surgical training in in the South West of the UK and at the University of Toronto, and am fellowship trained in adult spine surgery, paediatric spine surgery, orthopaedic trauma surgery, research and healthcare management.
I am driven to support patients at every stage of their care, from clinic assessment, through surgery to discharge. Making sure that every person, adult, child, family or friend understands what’s wrong, helping them to choose the right treatment for them, and what the recovery will be like is an important priority.
My research activity focusses on finding effective new treatments for spinal disorders and bringing them to patients. Focusing on spinal deformity, I have led investigations in the UK, Canada and the USA, and I sit on the Global AO Knowledge Forum for Deformity and the Research Grants Committee at the Scoliosis Research Society. I have lectured in North America and Europe about the treatment of spine disorders for the Scoliosis Research Society, Global Spine Congress, AO Spine and Eurospine, and I have worked hard to produce research that improves the care for spine patients wherever they live. Lastly, I review for several orthopaedic journals and I am Deputy Editor of the Bone and Joint 360, a leading publication with a global readership.
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