A Prospective, Multi-center, Randomized, Parallel-group Controlled Trial to Compare Conservative Versus Surgical Treatment of Foot Drop in Peroneal Nerve Entrapment.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peroneal Nerve Entrapment
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Enrollment
- 182
- Locations
- 18
- Primary Endpoint
- The difference in distance covered in meters during the six-minute walk test (6MWD) between baseline and 9 months after randomization.
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
The FOOT DROP trial is a prospective, multi-center, randomized controlled trial to assess if decompressive surgery for peroneal nerve entrapment is superior to maximal conservative treatment.
Patients with persisting foot drop due to peroneal nerve entrapment will be randomized to either surgery or conservative treatment if foot drop persists 10 +/- 4 weeks after onset of symptoms.
Patients will be evaluated through several questionnaires, evolution of muscle strength and several types of gait assessments. Primary endpoint is the difference in distance covered during the six minute walking test between baseline and 9 months after randomization.
Detailed Description
The Foot Drop Trial is the first prospective, randomised controlled trial to investigate the treatment of foot drop in peroneal nerve entrapment. Currently, the literature consists mostly of biased retrospective case series with the exception of some small (biased) prospective case series. No comparative trials have been conducted. The goal of the trial is to assess whether foot drop due to peroneal nerve entrapment recovers better 9 months after decompressive surgery compared to maximal conservative treatment. Patients with persisting foot drop (MRC score ankle dorsiflexion ≤ 3) after 10 +/- 4 weeks after onset of symptoms will be randomised to either decompressive surgery within 1 week after randomisation or maximal conservative treatment focussing on physiotherapy and gait rehabilitation. Blinded outcome assessors will evaluate participants at study visits 10 days (surgical group), 6 weeks, 3 months, 6 months, 9 months (primary outcome) and 18 months (extended follow-up) after randomization. Outcome assessors will conduct several assessments to evaluate gait improvement (6-minute walk test, 10-meter walk test, Stanmore questionnaire, functional ambulation categories, ability to walk barefoot, need for foot-ankle orthosis), muscle strength (MRC score for ankle dorsiflexion, ankle eversion, hallux extension) , quality of life (EQ-5D 5L) and cost-effectiveness of both treatment strategies (work productivity and activity impairment questionnaire (WPAI), return to work, percentage of invalidity). Electrodiagnostic follow-up will be registered at 3 months and 9 months after randomization. The primary endpoint of the foot drop trial is the difference in distance covered in meters during the six-minute walk test (6MWD) between baseline and 9 months after randomization. Time to recovery, defined as the time necessary to cover the minimal age- and sex-specific normal 6MWD AND the time necessary for foot drop recovery to an MRC-score ≥ 4 for ankle dorsiflexion is the key secondary endpoint. No cross-over to surgery is allowed before primary endpoint is reached. The study first succesfully piloted in 6 centers in Belgium and the Netherlands and is currently starting on a large scale in 20 centers.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Written informed consent to participate in the study must be obtained from the subject or proxy / legal representative prior to initiation of any study-mandated procedure
- •EDX-documented peroneal nerve entrapment with persisting (10 ± 4 weeks) foot drop (MRC-score ≤ 3)
- •Imaging (ultrasound/MRI) performed to exclude a compressive mass
- •Age ≥ 18 years
Exclusion Criteria
- •Subjects with posttraumatic or iatrogenic peroneal nerve injury
- •Subjects with peroneal neuropathy due to a compressive mass (e.g. cyst, tumour)
- •Peroneal nerve entrapment at other sites than the fibular head
- •Patients with mental or physical problems that incapacitate them to participate in a physiotherapy program
- •Psychiatric illness
- •Pregnancy
- •Planned (e)migration within 1 year after randomization to another country
- •Subjects with previous foot drop
- •Permanently bedridden subjects
- •Subjects with neurological or musculoskeletal history which could impact foot drop assessment and/or gait analysis (e.g. polyneuropathy, hereditary neuropathy with pressure palsies, critical illness polyneuropathy, previous stroke, ankle surgery, ...).
Outcomes
Primary Outcomes
The difference in distance covered in meters during the six-minute walk test (6MWD) between baseline and 9 months after randomization.
Time Frame: 9 months
Based on a literature analysis and patient feedback on the trial design, gait analysis and recovery of a normal gait pattern are crucial in the recovery of foot drop. In 90% of interviewed patients, success of treatment was related to improvement in gait. The distance covered during the six-minute walk test (6MWT) is validated and clinically used in gait analysis. 6MWT: patients are instructed to walk as far as possible within six minutes (strokes of 30 meters of more). The minimal age- and sex-specific normal 6MWD is defined as 82% of the applied reference equations for prediction of the 6MWD. The reference value that will be used is 6MWDpred(m) = 868.8 - (ageyears x 2.99) - (gender x 74.7). The value for gender is 0 in male subjects and 1 in female subjects.
Secondary Outcomes
- Time to recovery(6 weeks, 3 months, 6 months, 9 months and 18 months (after randomization))
- Gait assessment: Gait speed as measured by the 10-meter walk test(6 weeks, 3 months, 6 months, 9 months and 18 months (after randomization))
- Ankle dorsiflexion strength as measured by the Medical Research Council score (MRC-score).(10 days (surgery), 6 weeks, 3 months, 6 months, 9 months and 18 months (after randomization)))
- Gait assessment: Stanmore questionnaire(6 weeks, 3 months, 6 months, 9 months and 18 months (after randomization))
- Health economic assessment: Work Productivity and Activity Impairment Questionnaire (WPAI)(6 weeks and 6 months after randomization)
- Electrodiagnostics: evolution of conduction block at the level of the fibular head(3 months and 9 months after randomization.)
- Complications and neurologic deficits: Motor changes as assessed by the Medical Research Council Score (MRC-score) for ankle eversion(10 days (surgery), 6 weeks, 3 months, 6 months, 9 months and 18 months (after randomization))
- Ankle dorsiflexion strength as measured by isometric dynamometry.(10 days (surgery), 6 weeks, 3 months, 6 months, 9 months and 18 months (after randomization)))
- Complications and neurologic deficits: Motor changes as assessed by the Medical Research Council Score (MRC-score) for hallux extension(10 days (surgery), 6 weeks, 3 months, 6 months, 9 months and 18 months (after randomization)))
- Gait assessment: Difference in distance covered in meters during the six-minute walk test(6 weeks, 3 months, 6 months and 18 months (after randomization))
- Gait assessment: Functional ambulation categories(6 weeks, 3 months, 6 months, 9 months and 18 months (after randomization))
- Patient-reported outcome measurements regarding health-related quality of life: 5 Level Euro Quality of Life 5 Dimensions (EQ5D-5L)(10 days (surgery), 6 weeks, 3 months, 6 months, 9 months and 18 months (after randomization))
- Complications and neurologic deficits: Sensory changes(10 days (surgery), 6 weeks, 3 months, 6 months, 9 months and 18 months (after randomization)))
- Complications and neurologic deficits: Surgical complications(10 days, 6 weeks and 18 months after surgery)
- Gait assessment: The proportion of patients in both groups who reach minimal normal age- and sex-specific reference values for distance covered in meters during the six-minute walk test(9 months after randomization)
- Health economic assessment: Return to work(6 weeks)