Objective:
To evaluate whether mecobalamin can prevent complex regional pain syndrome type 1 (CRPS-1) following foot and ankle surgery.
Approach:
- Study Design: A single-center trial conducted between June 2022 and May 2025 involving 440 adult patients.
- Intervention: Patients were randomly assigned to receive either mecobalamin 500 μg or placebo three times daily for 50 days post-surgery.
- Outcomes: Primary outcome was the incidence of CRPS-1 diagnosed using the Budapest criteria; secondary outcomes included pain (VAS), activities of daily living (FAAM), and quality-of-life scores (SF-36).
Key Findings:
- 2% of patients receiving mecobalamin developed CRPS-1 compared to 9% in the placebo group.
- Adjusted absolute risk reduction for CRPS-1 was about 8%; number needed to treat to prevent one case was 14.
- Patients in the mecobalamin group experienced greater improvement in postoperative pain and functional outcomes.
Interpretation:
Prophylactic mecobalamin significantly lowered the event rate of CRPS-1 after foot and ankle surgery.
Limitations:
- Conducted at a single center.
- CRPS-1 diagnoses made by one reviewer using standardized criteria.
- Baseline differences in functional and mental health scores required adjusted analyses.
- Magnitude of treatment effects was relatively modest and needs confirmation in larger multicenter studies.
Conclusion:
Prophylactic mecobalamin may reduce CRPS-1 incidence and improve postoperative outcomes.
Sources:
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