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.
