A randomized controlled trial comparing conservative versus surgical treatment in patients with foot drop due to peroneal nerve entrapment: results of an internal feasibility pilot study

Christophe Oosterbos; Sofie Rummens; Kris Bogaerts; Anaïs Van Hoylandt; Sophie Hoornaert; Frank Weyns; Annie Dubuisson; Jeroen Ceuppens; Sophie Schuind; Justus L Groen; Robin Lemmens; Tom Theys

doi:10.1186/s40814-023-01407-x

A randomized controlled trial comparing conservative versus surgical treatment in patients with foot drop due to peroneal nerve entrapment: results of an internal feasibility pilot study

Pilot Feasibility Stud. 2023 Oct 31;9(1):181. doi: 10.1186/s40814-023-01407-x.

Authors

Christophe Oosterbos^{1

2}, Sofie Rummens³, Kris Bogaerts⁴, Anaïs Van Hoylandt^{5

6}, Sophie Hoornaert^{5

6}, Frank Weyns^{7

8}, Annie Dubuisson⁹, Jeroen Ceuppens¹⁰, Sophie Schuind¹¹, Justus L Groen¹², Robin Lemmens^{13

14

15}, Tom Theys^{5

6}

Affiliations

¹ Research Group experimental Neurosurgery and Neuroanatomy KULeuven and the Leuven Brain Institute, Leuven, Belgium. christopheoosterbos@gmail.com.
² Department of Neurosurgery, University Hospitals Leuven, Leuven, Belgium. christopheoosterbos@gmail.com.
³ Department of Physical Medicine and Rehabilitation, University Hospitals Leuven, Leuven, Belgium.
⁴ Department of Public Health and Critical Care, I-BioStat, KU Leuven, Belgium and I-BioStat, UHasselt, Belgium.
⁵ Research Group experimental Neurosurgery and Neuroanatomy KULeuven and the Leuven Brain Institute, Leuven, Belgium.
⁶ Department of Neurosurgery, University Hospitals Leuven, Leuven, Belgium.
⁷ Department of Neurosurgery, Ziekenhuis-Oost Limburg, Genk, Belgium.
⁸ Neurosciences, Faculty of Medicine and Life Sciences, UHasselt, Hasselt, Belgium.
⁹ Department of Neurosurgery, University Hospitals Liège, Liège, Belgium.
¹⁰ Department of Neurosurgery, Algemeen Ziekenhuis Groeninge, Kortrijk, Belgium.
¹¹ Department of Neurosurgery, Erasme Hospital, Brussels, Belgium.
¹² Leiden Nerve Center, Department of Neurosurgery, University of Leiden, Leiden, the Netherlands.
¹³ KU Leuven-University of Leuven, Department of Neurosciences, Experimental Neurology, Leuven, Belgium.
¹⁴ VIB, Center for Brain & Disease Research, Laboratory of Neurobiology, Leuven, Belgium.
¹⁵ Department of Neurology, University Hospitals Leuven, Leuven, Belgium.

Abstract

Background: Based on the lack of literature to support any treatment strategy in patients with foot drop due to peroneal nerve entrapment, a prospective study randomizing patients between surgery and conservative treatment is warranted. Since studies comparing surgery to no surgery are often challenging, we first examined the feasibility of such a randomized controlled trial.

Methods/design: An internal feasibility pilot study was conducted to assess several aspects of process, resource, management, and scientific feasibility. The main objective was the assessment of the recruitment rate. The criterion to embark on a full study was the recruitment of at least 14 patients in 6 participating centers within 6 months. Cross-over rate, blinding measures, training strategies, and trial assessments were evaluated. The trial was entirely funded by the KCE Trials public funding program of the Belgian Health Care Knowledge Centre (ID KCE19-1232).

Results: The initial duration was prolonged due to the COVID-19 pandemic. Between April 2021 and October 2022, we included 19 patients of which 15 were randomized. Fourteen patients were treated as randomized. One drop-out occurred after randomization, prior to surgery. We did not document any cross-over or accidental unblinding. Training strategies were successful. Patients perceived the quality of life questionnaire as the least relevant assessment. Assessment of ankle dorsiflexion range of motion was prone to interobserver variability. All other trial assessments were adequate.

Discussion: Recruitment of the anticipated 14 patients was feasible although slower than expected. The Short-Form Health Survey (SF-36) and assessment of ankle dorsiflexion range of motion will no longer be included in the full-scale FOOTDROP trial.

Conclusion: The FOOTDROP study is feasible.

Trial registration: ClinicalTrials.gov, identifier NCT04695834 . Registered 4 January 2021.

Keywords: Conservative treatment; Feasibility; Foot drop; Neurolysis; Peroneal nerve; Randomized controlled trial.

Associated data

ClinicalTrials.gov/NCT04695834