Prospective Randomized Control Pilot Study to Compare the Role of Injection Cerebrolysin in Operated cases of Degenerative Cervical Myelopathy.

Abstract

Study designProspective randomized control trial.ObjectiveThe aim of this study was to analyze role of cerebrolysin in patients of degenerative cervical myelopathy (DCM) managed by surgical modalities.Summary of background dataCerebrolysin has been extensively researched with variable success in neurodegenerative pathologies. There has been only one study in published literature till date that has studied role of cerebrolysin in DCM in conservatively managed patients but none in the patients treated surgically. We present our pilot study which analyzes the role of cerebrolysin in patients of DCM managed by surgical modalities.MethodsThis prospective randomized control trial was conducted at a tertiary care institute in Mumbai. Sixty operated cases of DCM were randomly divided into 2 groups. The first group was given Injection Cerebrolysin 5 mL diluted in 100 mL Normal Saline over 30 minutes once a day for 21 days postoperatively. The second group was given placebo. Modified Japanese Orthopedic Association scores (mJOA) and visual analog scale (VAS) were used to document functional outcomes at 3 weeks, 3 months, 6 months, and 1 year. Recovery of hand function was separately accessed by improvement in hand power and sensations.ResultsPreoperative mJOA and VAS scores were comparable between 2 groups. Both groups showed significant improvement in both mJOA and VAS scores at 3weeks, 3 months, 6 months and 1-year follow-up (P < 0.01). In comparing the two groups, there was no difference in improvement of mJOA and VAS scores. However, cerebrolysin group showed significant improvement in hand function at 1 year compared to the placebo. Postoperative neurological recovery was better in the cerebrolysin group with 66.7% patients showing complete neurological recovery compared to 56.7% for placebo, but this was statistically insignificant. Two patients developed headache and one patient complained of dizziness in the cerebrolysin group, but these resolved without any intervention.ConclusionUse of cerebrolysin in postoperative cases of DCM is safe and results in improved hand function.Level of Evidence: 1.