A comparison of conservative versus surgical treatment in patients with foot drop due to peroneal nerve entrapment: results of a prematurely terminated randomized controlled trial

Abstract

Background: Patients with foot drop due to peroneal nerve entrapment are treated with either conservative or surgical approaches, yet the optimal strategy remains unclear due to limited evidence. We aim to investigate whether neurolysis of the peroneal nerve is superior to conservative treatment. Methods: This multicenter randomized controlled trial aimed to compare maximal conservative treatment with peroneal nerve neurolysis in patients with persistent foot drop (6 to 14 weeks post-onset). The primary endpoint was the change in distance covered during the 6-min walk test (6MWD) between randomization and 9 months. Secondary outcomes including time to recovery, gait, muscle strength, surgical complications, electrodiagnostics, and quality of life, were assessed at 6 weeks, 3 months, 6 months, 9 months and 18 months. Results: The study ended prematurely due to recruitment challenges, with only 26 patients were randomized across 7 centers (12 to conservative treatment, 14 to surgery). No significant difference in 6MWD was observed at 9 months (564 m in the conservative group vs. 480 in the surgical group). Time to recovery which was faster in the conservative group (p = 0.02). Both groups showed improvements in muscle strength, gait and quality of life. Conclusion: Recruitment difficulties stemmed from the condition's low incidence, strict eligibility criteria and high spontaneous recovery rate. Despite the trial's termination, results suggest clinical equipoise and good outcome regardless of treatment choice. Further research is needed to determine the role and timing of neurolysis.