Edema after foot and ankle surgery is associated with unsatisfactory outcomes. It impairs postoperative mobilization, range of motion, pain, wound healing, and risk of venous thrombosis. The aim of this study is to determine if activation of the venous muscle pump by neuromuscular stimulation of the common peroneal nerve reduces postoperative edema in the foot and ankle.
80 patients having forefoot or hindfoot surgery were randomized to receive standard care following surgery, or a wearable self-adhesive neuromuscular stimulation device applied to the skin below the knee laterally at the head of fibula. This provided intermittent (1 hertz) stimulation of the common peroneal nerve, eliciting a twitch of the muscles of the leg. Edema was measured as the difference between the involved and uninvolved limb, measured by figure-of-eight method of the foot and ankle. Baseline was measured preoperatively and then 14 days following surgery.
Figure-of-eight measurement in patients receiving standard care increased relative to baseline by 4.9% (95% CI 4.3%-5.4%) 14 days post-surgery, whereas patients receiving neuromuscular stimulation increased by 3.3% (95%CI 2.7%-3.6%). Patients receiving neuromuscular stimulation had 33% less edema (p<0.05) than those receiving standard care.
Competing Interest StatementThe authors have declared no competing interest.
Clinical TrialNCT04927234
Funding StatementThe study was funded by Firstkind Ltd
Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
Yes
The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
Ethics committee of the Hospital Clinic de Barcelona Spain the Hospital Universitario Vall de Hebron, Spain the West of Scotland Research Ethics Service West of Scotland REC 4 UK and the IRB Western Institutional Review Board part of WCG (WIRB-Copernicus Group) USA all gave ethical approval for this work
I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.
Yes
I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
Yes
I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.
Yes
FootnotesFinancial Disclosure This research was funded by Firstkind Ltd.
Conflict of Interest Declaration Each author certifies that he or she has no commercial associations that might pose a conflict of interest in connection with the submitted article.
Data AvailabilityAll data produced in the present study are available upon reasonable request to the authors
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