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Open Access 01-12-2022 | Study protocol

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

Authors: Christophe Oosterbos, Sofie Rummens, Kris Bogaerts, Sophie Hoornaert, Frank Weyns, Annie Dubuisson, Robin Lemmens, Tom Theys

Published in: Trials | Issue 1/2022

Abstract

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.

Available only for authorised users

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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
Authors: Christophe Oosterbos
Sofie Rummens
Kris Bogaerts
Sophie Hoornaert
Frank Weyns
Annie Dubuisson
Robin Lemmens
Tom Theys
Publication date: 01-12-2022
Publisher: BioMed Central
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-07009-x

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Abstract

Background

Methods/design

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods/design

Discussion

Trial registration

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