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

Oosterbos, C.; Rummens, S.; Bogaerts, K.; Hoornaert, S.; Weyns, F.; Dubuisson, Annie; Lemmens, R.; Theys, T.

doi:10.1186/s13063-022-07009-x

Article (Scientific journals)

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

Oosterbos, C.; Rummens, S.; Bogaerts, K. et al.

2022 • In Trials, 23 (1)

Peer Reviewed verified by ORBi

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https://hdl.handle.net/2268/303696

DOI
10.1186/s13063-022-07009-x

PubMed
36581937

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Keywords :

Conservative treatment; Foot drop; Neurolysis; Peroneal nerve; Protocol design; Randomized controlled trial; adult; ankle dorsiflexion angle; Article; clinical feature; comparative effectiveness; controlled study; European Quality of Life 5 Dimensions 5 Level questionnaire; female; functional status; human; major clinical study; male; multicenter study; nerve compression; nerve decompression; patient-reported outcome; peroneal nerve entrapment; peroneus nerve paralysis; prospective study; randomized controlled trial; risk factor; six minute walk test; ten minute walk test; walk test; ankle; clinical trial; paresis; peroneal neuropathy; treatment outcome; Ankle; Ankle Joint; Humans; Paresis; Peroneal Neuropathies; Prospective Studies; Treatment Outcome

Abstract :

[en] Background: High-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/design: The 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. Discussion: The results of this randomized trial may elucidate the role of surgical decompression of the peroneal nerve and aid in clinical decision-making. Trial registration: ClinicalTrials.gov NCT04695834. Registered on 4 January 2021. © 2022, The Author(s).

Disciplines :

Surgery

Author, co-author :

Oosterbos, C.; Research Group experimental Neurosurgery and Neuroanatomy and the Leuven Brain Institute, KU Leuven, Leuven, Belgium, Department of Neurosurgery, University Hospitals Leuven, Leuven, Belgium

Rummens, S.; Department of Physical Medicine and Rehabilitation, University Hospitals Leuven, Leuven, Belgium, Locomotor and Neurological disorders, KU Leuven, Leuven, Belgium

Bogaerts, K.; Department of public health and critical care, I-BioStat, KU Leuven, Belgium and I-BioStat, UHasselt, Hasselt, Belgium

Hoornaert, S.; Research Group experimental Neurosurgery and Neuroanatomy and the Leuven Brain Institute, KU Leuven, Leuven, Belgium, Department of Neurosurgery, University Hospitals Leuven, Leuven, Belgium

Weyns, F.; Department of Neurosurgery, Ziekenhuis Oost-Limburg, Genk, Belgium, Neurosciences, Faculty of Medicine and Life Sciences, UHasselt, Hasselt, Belgium

Dubuisson, Annie ; Centre Hospitalier Universitaire de Liège - CHU > > Service de neurochirurgie

Lemmens, R.; 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

Theys, T.; Research Group experimental Neurosurgery and Neuroanatomy and the Leuven Brain Institute, KU Leuven, Leuven, Belgium, Department of Neurosurgery, University Hospitals Leuven, Leuven, Belgium

Language :

English

Title :

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

Publication date :

2022

Journal title :

Trials

eISSN :

1745-6215

Publisher :

BioMed Central Ltd

Volume :

Issue :

Peer reviewed :

Peer Reviewed verified by ORBi

Funding text :

The FOOT DROP trial is funded by the Belgian Knowledge Health Care Centre (KCE) under the KCE Trials funding programme (KCE19-1232). During the selection process, methodological independent experts gave comments on the protocol.

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