Conservative versus surgical treatment of foot drop in peroneal nerve entrapment: rationale and design of a prospective, multi-centre, randomized parallel-group controlled trial

Trials

Study Protocol

Robin Lemmens¹  Annie Dubuisson²  Frank Weyns³  Sofie Rummens⁴  Kris Bogaerts⁵  Tom Theys⁶  Christophe Oosterbos⁶  Sophie Hoornaert⁶ 

[1] Department of Neurosciences, Experimental Neurology, KU Leuven – University of Leuven, Leuven, Belgium;VIB, Center for Brain & Disease Research, Laboratory of Neurobiology, Leuven, Belgium;Department of Neurology, University Hospitals Leuven, Leuven, Belgium;Department of Neurosurgery, University Hospitals Liège, Liège, Belgium;Department of Neurosurgery, Ziekenhuis Oost-Limburg, Genk, Belgium;Neurosciences, Faculty of Medicine and Life Sciences, UHasselt, Hasselt, Belgium;Department of Physical Medicine and Rehabilitation, University Hospitals Leuven, Leuven, Belgium;Locomotor and Neurological disorders, KU Leuven, Leuven, Belgium;Department of public health and critical care, I-BioStat, KU Leuven, Belgium and I-BioStat, UHasselt, Hasselt, Belgium;Research Group experimental Neurosurgery and Neuroanatomy and the Leuven Brain Institute, KU Leuven, Leuven, Belgium;Department of Neurosurgery, University Hospitals Leuven, Leuven, Belgium;

关键词: Randomized controlled trial;    Foot drop;    Peroneal nerve;    Neurolysis;    Conservative treatment;    Protocol design;   

DOI  :  10.1186/s13063-022-07009-x

 received in 2022-11-10, accepted in 2022-12-12,  发布年份 2022

来源: Springer

【 摘 要 】

BackgroundHigh-quality evidence is lacking to support one treatment strategy over another in patients with foot drop due to peroneal nerve entrapment. This leads to strong variation in daily practice.Methods/designThe FOOTDROP (Follow-up and Outcome of Operative Treatment with Decompressive Release Of The Peroneal nerve) trial is a randomized, multi-centre study in which patients with peroneal nerve entrapment and persistent foot drop, despite initial conservative treatment, will be randomized 10 (± 4) weeks after onset between non-invasive treatment and surgical decompression. The primary endpoint is the difference in distance covered during the 6-min walk test between randomization and 9 months later. Time to recovery is the key secondary endpoint. Other secondary outcome measures encompass ankle dorsiflexion strength (MRC score and isometric dynamometry), gait assessment (10-m walk test, functional ambulation categories, Stanmore questionnaire), patient-reported outcome measures (EQ5D-5L), surgical complications, neurological deficits (sensory changes, motor scores for ankle eversion and hallux extension), health economic assessment (WPAI) and electrodiagnostic assessment.DiscussionThe results of this randomized trial may elucidate the role of surgical decompression of the peroneal nerve and aid in clinical decision-making.Trial registrationClinicalTrials.gov NCT04695834. Registered on 4 January 2021.

【 授权许可】

CC BY   
© The Author(s) 2022

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