Peroneal Nerve EntrapmentFOOTDROPNCT04695834
Follow-up and Outcome of Operative Treatment With Decompressive Release Of The Peroneal Nerve
A study testing Neurolysis peroneal nerve and Maximal physiotherapy in people with Peroneal Nerve Entrapment, run by Universitaire Ziekenhuizen KU Leuven at 18 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peroneal Nerve Entrapment
- What is being tested?
- Neurolysis peroneal nerve and Maximal physiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 18 sitesin 2 countries
- Study dates
- 28 Apr 2021to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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, …).
Trial locations and contacts
18 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
18 sites in 2 countries
Belgium17 sites, 17 recruiting
- Not yet recruiting
Universitaire Ziekenhuizen Antwerpen
Antwerp, 2000
Tomas Menovsky, M.D.: PhD, +323 821 33 28
Tomas Menovsky, M.D.: PhD
- Not yet recruiting
AZ Sint-Jan
Bruges, West-Vlaanderen, 8000
Nikolaas Vantomme, M.D., +3250452300
Nikolaas Vantomme, M.D.
- Recruiting
ULB Erasme, department of neurosurgery
Brussels, 1000
Sophie Schuind, M.D., sophie.schuind@ulb.erasme.ac.be
Sophie Schuind, M.D.
- Not yet recruiting
UZ Brussel
Brussels, 1000
Johhny Duerinck, M.D.; PhD, +322 477 60 12
Johnny Duerinck, M.D.; PhD
- Not yet recruiting
AZ Alma
Eeklo, Oost-Vlaanderen, 9900
Kristel Vanchaze, M.D., +329 310 19 69
Kristel Vanchaze, M.D.
- Recruiting
Ziekenhuis Oost-Limburg, department of neurosurgery
Genk, 3600
Frank Weyns, M.D., +3289326043, frank.weyns@zol.be
Frank Weyns, M.D.
- Not yet recruiting
AZ Sint-Lucas
Ghent, Oost-Vlaanderen, 9000
Kristel Vanchaze, M.D., secretariaat.neurochirurgie@azstlucas.be
Kristel Vanchaze, M.D.
- Not yet recruiting
Jessa Ziekenhuis
Hasselt, Limburg, 3500
Gert Roosen, M.D., +3211335511
Gert Roosen, M.D.
- Recruiting
AZ Groeninge, department of neurosurgery
Kortrijk, West-Vlaanderen, 8500
Jeroen Ceuppens, M.d., jeroen.ceuppens@azgroeninge.be
Jeroen Ceuppens, M.D.
- Recruiting
University Hospitals Of Leuven, department of neurosurgery
Leuven, 3000
Tom Theys, M.D., Ph.D., +3216344290, tom.theys@uzleuven.be
Tom Theys, M.D.; Ph.D.
- Recruiting
CHU de Liège, department of neurosurgery
Liège, 4000
Annie Dubuisson, M.D., Ph.D., a.dubuisson@chuliege.be
Annie Dubuisson, M.D.; Ph.D.
- Not yet recruiting
AZ Sint-Maarten
Mechelen, Antwerpen, 2800
Pieter Jan Van Dyck - Lippens, M.D., +3215891010
Pieter Jan Van Dyck - Lippens, M.D.
- Not yet recruiting
AZ Damiaan
Ostend, West-Vlaanderen, 8400
Adinda De Pauw, M.D., +3259414060
Adinda De Pauw, M.D.
- Not yet recruiting
AZ Delta
Roeselare, West-Vlaanderen, 8800
Jeroen Van Lerbeirghe, M.D., secr.neurochirurgie.rumbeke@azdelta.be
Jeroen Van Leirberghe, M.D.
- Not yet recruiting
AZ Vesalius
Tongeren, Limburg, 3717
Louise Schoolderman, M.D., +3212397912
Louise Schoolderman, M.D.
- Not yet recruiting
AZ Turnhout
Turnhout, Antwerpen, 2300
Jens Deckers, M.D., +3214406184
Jens Deckers, M.D.
- Not yet recruiting
Sint Augustinus
Wilrijk, Antwerpen, 2610
Tony Van Havenbergh, M.D.; PhD, info@neurochirurgiegroep.be
Tony Van Havenbergh, M.D.; PhD
Netherlands1 site, 1 recruiting
- Recruiting
Leids Universitair Medisch Centrum, department of neurosurgery
Leiden, 2333
Justus Groen, M.D., J.L.Groen@lumc.nl
Justus Groen, M.D.
About this study
Official title: A Prospective, Multi-center, Randomized, Parallel-group Controlled Trial to Compare Conservative Versus Surgical Treatment of Foot Drop in Peroneal Nerve Entrapment.
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.
Read the 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.
- Conditions
- Peroneal Nerve Entrapment
- Being tested
- Neurolysis peroneal nerve, Maximal physiotherapy
- Keywords
- Peroneal nerve, Neurolysis, Conservative treatment, Randomised controlled trial, Foot drop
- Medical subject headings
- Peroneal Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurolysis peroneal nerveProcedure or surgery
The surgical approach for entrapment at the fibular head is usually through a curvilinear incision just distal to the fibular head. The subcutaneous tissue is bluntly dissected, and the common peroneal nerve is identified proximal to the peroneus longus muscle. The peroneal nerve is then released from the surrounding fibrous tissue and fascia. The nerve is decompressed distally as it dives under the peroneus longus muscle. The decompression at this site is essential. Certain authors state that an adequate decompression should extend beyond the bifurcation in the deep and superficial peroneal nerve and should involve cutting the intermuscular septa
Maximal physiotherapyOther
Mobilization of ankle and foot, stretching of the calf muscles (prevention of contractures) Tonification of the dorsiflexion- and eversion muscles of the ankle Proprioceptive training Gait rehabilitation Home exercise schedule
| Study group | Role | What they receive |
|---|---|---|
| Conservative treatment | Active comparator | Patients that are randomized to the conservative arm of the trial. These patients will not be operated until primary endpoint is reached.
If necessary, cross-over can occur after primary endpoint is reached.
Conservative treatment is considered standard of care. Receives: Other: Maximal physiotherapy |
| Surgical treatment | Active comparator | Patients randomized to the surgical arm will be operated within 1 week after randomization (if possible within 2 days).
Neurolysis is considered standard of care. Receives: Procedure: Neurolysis peroneal nerve |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in distance covered in meters during the six-minute walk test (6MWD) between baseline and 9 months after randomization.
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.
Measured: 9 months
Secondary outcomes (16)
Time to recovery
KEY SECONDARY ENDPOINT Time to recovery is defined as: the time necessary to cover the minimal age- and sex-specific normal distance in meters during the 6-minute walking test (6MWT) AND the time necessary for foot drop recovery to an MRC-score ≥ 4 for ankle dorsiflexion.
The MRC-score is a clinical assessment of muscle strength. MRC-ranges from 0 to 5 with zero indicating no movement at all and 5 indicating normal muscle strength.
The minimal age- and sex-specific normal 6-minute walking distance (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.
Measured: 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).
Medical Research Council (MRC)-score as clinical assessment of muscle strength. MRC-score ranges from 0 to 5.
0: no movement
- contraction of muscle, but no movement
- movement, but not against gravity
- movement against gravity, but not against resistance
- movement against resistance
- normal strength
Measured: 10 days (surgery), 6 weeks, 3 months, 6 months, 9 months and 18 months (after randomization))
Ankle dorsiflexion strength as measured by isometric dynamometry.
Recovery of ankle dorsiflexion strength is essential in patients with foot drop. The use of dynamometry allows to document ankle dorsiflexion strength in an objective manner.
Patients are asked to lay in supine position, with the knees extended. The test pad of the dynamometer is placed on the dorsal head of the first metatarsal bone. The patient is instructed to perform ankle dorsiflexion with maximal muscle strength. The best of three attempts is registered. Ankle dorsiflexion is measured and reported in both ankles (in kilograms). The ankle dorsiflexion strength ratio, defined as the ratio of ankle dorsiflexion strength in the affected ankle over ankle dorsiflexion strength in the healthy ankle will be calculated and reported
Measured: 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
Medical Research Council (MRC)-score as clinical assessment of muscle strength. MRC-score ranges from 0 to 5.
0: no movement
- contraction of muscle, but no movement
- movement, but not against gravity
- movement against gravity, but not against resistance
- movement against resistance
- normal strength
Measured: 10 days (surgery), 6 weeks, 3 months, 6 months, 9 months and 18 months (after randomization))
Complications and neurologic deficits: Sensory changes
In a large retrospective patient series on peroneal nerve decompression after weight loss, Broekx et al. (2018) examined the recovery of sensory deficits. Symptoms qualified as sensory included the presence of hypoesthesia and/or paresthesia. They used the following system to assess sensory symptoms:
- Complete recovery: the absence of any sensory symptoms
- Partial recovery: patients with a minimum of sensory symptoms
- No recovery: patients with no improvement
Measured: 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
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.
Measured: 6 weeks, 3 months, 6 months and 18 months (after randomization)
Gait assessment: Stanmore questionnaire
The Stanmore questionnaire has been used in the literature to assess functional outcome in patients with foot drop due to peroneal nerve injury. Seven sections (pain, need for orthosis, normal shoes, functional outcome, muscle power, degree of active dorsiflexion and foot posture) add up to a sum score of 100 points.
Measured: 6 weeks, 3 months, 6 months, 9 months and 18 months (after randomization)
Gait assessment: Functional ambulation categories
Functional ambulation categories (FAC) is a useful scale to assess gait in patients with foot drop. It is a six point scale, that is used in stroke literature and can help determine how much assistance a patient requires.
FAC 0 reflects a nonfunctional state and FAC 5 equals a normal gait pattern.
Measured: 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
Walking speed is an important aspect of gait and is often used as an objective measure of functional mobility. The 10-meter walk test is a commonly used and validated tool to assess gait speed.
Measured: 6 weeks, 3 months, 6 months, 9 months and 18 months (after randomization)
Health economic assessment: Work Productivity and Activity Impairment Questionnaire (WPAI)
Health economic aspects of foot drop will be evaluated through the Work Productivity and Activity Impairment Questionnaire (WPAI). The WPAI is widely used and validated in multiple languages.
The WPAI questionnaire consists of 6 questions with regard to professional activity during the past 7 days.
Measured: 6 weeks and 6 months after randomization
Complications and neurologic deficits: Surgical complications
A list of possible complications is made available to all participating centers. Unforeseen complications will be recorded as free-text.
Measured: 10 days, 6 weeks and 18 months after surgery
Electrodiagnostics: evolution of conduction block at the level of the fibular head
All patients will have repeated electrodiagnostic examinations. The evolution of the conduction block at the level of the fibular head will be documented in the eCRF.
Measured: 3 months and 9 months after randomization.
Patient-reported outcome measurements regarding health-related quality of life: 5 Level Euro Quality of Life 5 Dimensions (EQ5D-5L)
The EQ-5D 5L is a generic measure of health-related quality of life developed by the EuroQol Group. It is a validated measurement of quality of life widely used in different pathologies. The questionnaire is made up of two parts. The first part is descriptive and uses five different dimensions to score quality of life. These five dimensions are mobility, self-care, activities of the daily life, pain/discomfort and anxiety/depression. There are five different answer possibilities within each dimension, i.e. "no problem", "slight problem", "moderate problem", "severe problem" and "unable to". This renders 3125 different answer possibilities. The second part uses a visual analogue scale (VAS) to score the current health status of the patient, ranging from zero to one hundred. Zero corresponds to death and one hundred corresponds to a (subjective) perfect health status.
Measured: 10 days (surgery), 6 weeks, 3 months, 6 months, 9 months and 18 months (after randomization)
Health economic assessment: Return to work
Health economic aspects will also be evaluated through the assessment of return to work. We expect subgroups of patients with foot drop to be unable to work. Once the foot drop has improved (or fully recovered), we expect patients to be able to return to work and to not experience any more related problems (after their initial recovery). In this trial population foot drop does in general not represent a chronic condition with periods of relapse. Either the foot drop recovers enough to be able to work again, or the foot drop does not sufficiently recover to resume previous professional activities.
Taking this into account, return to work seems to represent a very important measure. Patients will be asked about return to work at the study visit six weeks after randomization. To avoid recall bias, patients will be asked in advance to record the date of return to work. During baseline assessments, subjects will be questioned if they are incapacitated to work due to the foot drop and the
Measured: 6 weeks
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
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.
Measured: 9 months after randomization
Complications and neurologic deficits: Motor changes as assessed by the Medical Research Council Score (MRC-score) for ankle eversion
Medical Research Council (MRC)-score as clinical assessment of muscle strength. MRC-score ranges from 0 to 5.
0: no movement
- contraction of muscle, but no movement
- movement, but not against gravity
- movement against gravity, but not against resistance
- movement against resistance
- normal strength
Measured: 10 days (surgery), 6 weeks, 3 months, 6 months, 9 months and 18 months (after randomization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start28 Apr 2021
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Peroneal Nerve EntrapmentStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective Multi-center Randomized Parallel-group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Belgian Health Care Knowledge Centre (KCE)
- Responsible party
- Sponsor
- Investigators
- Tom Theys, M.D.; Ph.D., Principal investigator, Univeristy hospitals of Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04695834
- Sponsor's protocol ID
- S62895
- Other IDs
- KCE19-1232
- Acronym
- FOOTDROP
- Status last verified
- Jun 2024
- First submitted
- 3 Dec 2020
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Poage C, Roth C, Scott B. Peroneal Nerve Palsy: Evaluation and Management. J Am Acad Orthop Surg. 2016 Jan;24(1):1-10. doi: 10.5435/JAAOS-D-14-00420.
PubMed 26700629Broekx S, Weyns F. External neurolysis as a treatment for foot drop secondary to weight loss: a retrospective analysis of 200 cases. Acta Neurochir (Wien). 2018 Sep;160(9):1847-1856. doi: 10.1007/s00701-018-3614-9. Epub 2018 Jul 1.
PubMed 29961126Cruz-Martinez A, Arpa J, Palau F. Peroneal neuropathy after weight loss. J Peripher Nerv Syst. 2000 Jun;5(2):101-5. doi: 10.1046/j.1529-8027.2000.00007.x.
PubMed 10905469Khedr EM, Fawi G, Allah Abbas MA, El-Fetoh NA, Zaki AF, Gamea A. Prevalence of Common Types of Compression Neuropathies in Qena Governorate/Egypt: A Population-Based Survey. Neuroepidemiology. 2016;46(4):253-60. doi: 10.1159/000444641. Epub 2016 Mar 15.
PubMed 26974980Kandil MR, Darwish ES, Khedr EM, Sabry MM, Abdulah MA. A community-based epidemiological study of peripheral neuropathies in Assiut, Egypt. Neurol Res. 2012 Dec;34(10):960-6. doi: 10.1179/1743132812Y.0000000099.
PubMed 23146298Poppler LH, Bansal A, Groves A, Sacks G, Davidge K, Mackinnon SE. Abstract 65: Subclinical Peroneal Nerve Entrapment May be an Under-recognized Cause of Falls in Hospitalized Patients. Plast Reconstr Surg. 2014 Mar;133(3 Suppl):76. doi: 10.1097/01.prs.0000445098.29964.cf. No abstract available.
PubMed 25942176Aprile I, Caliandro P, La Torre G, Tonali P, Foschini M, Mondelli M, Bertolini C, Piazzini DB, Padua L. Multicenter study of peroneal mononeuropathy: clinical, neurophysiologic, and quality of life assessment. J Peripher Nerv Syst. 2005 Sep;10(3):259-68. doi: 10.1111/j.1085-9489.2005.10304.x.
PubMed 16221285Aprile I, Padua L, Padua R, D'Amico P, Meloni A, Caliandro P, Pauri F, Tonali P. Peroneal mononeuropathy: predisposing factors, and clinical and neurophysiological relationships. Neurol Sci. 2000 Dec;21(6):367-71. doi: 10.1007/s100720070052.
PubMed 11441574Aprile I, Tonali P, Caliandro P, Pazzaglia C, Foschini M, Di Stasio E, Mondelli M, Padua L; Italian CTS and other entrapments Study Group. Italian multicentre study of peroneal mononeuropathy: multiperspective follow-up. Neurol Sci. 2009 Feb;30(1):37-44. doi: 10.1007/s10072-009-0010-5. Epub 2009 Jan 20.
PubMed 19153647Aprile I, Caliandro P, Foschini M, Di Stasio E, Padua L; Italian CTS and other Entrapments Study Group; Mondelli M. Multicentre study of peroneal mononeuropathy: multiperspective follow-up of nonsurgical cases. J Peripher Nerv Syst. 2007 Sep;12(3):232-3. doi: 10.1111/j.1529-8027.2007.00145.x. No abstract available.
PubMed 17868251Berry H, Richardson PM. Common peroneal nerve palsy: a clinical and electrophysiological review. J Neurol Neurosurg Psychiatry. 1976 Dec;39(12):1162-71. doi: 10.1136/jnnp.39.12.1162.
PubMed 1011026Bsteh G, Wanschitz JV, Gruber H, Seppi K, Loscher WN. Prognosis and prognostic factors in non-traumatic acute-onset compressive mononeuropathies--radial and peroneal mononeuropathies. Eur J Neurol. 2013 Jun;20(6):981-5. doi: 10.1111/ene.12150. Epub 2013 Mar 26.
PubMed 23530751Sipahioglu S, Zehir S, Askar H, Isikan UE. Peroneal nerve palsy secondary to prolonged squatting in seasonal farmworkers. Acta Orthop Traumatol Turc. 2015;49(1):45-50. doi: 10.3944/AOTT.2015.14.0074.
PubMed 25803253Sangwan SS, Marya KM, Kundu ZS, Yadav V, Devgan A, Siwach RC. Compressive peroneal neuropathy during harvesting season in Indian farmers. Trop Doct. 2004 Oct;34(4):244-6. doi: 10.1177/004947550403400424.
PubMed 15510960Fares MY, Dimassi Z, Fares J, Musharrafieh U. Peroneal neuropathy and bariatric surgery: untying the knot. Int J Neurosci. 2020 Apr;130(4):417-423. doi: 10.1080/00207454.2019.1694926. Epub 2020 Jan 6.
PubMed 31735096
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Randomized, Parallel-group Controlled Trial to Compare Conservative Versus Surgical Treatment of Foot Drop in Peroneal Nerve Entrapment.
- ClinicalTrials.gov ID
- NCT04695834
- Acronym / sponsor ID
- FOOTDROP / S62895
- Conditions
- Peroneal Nerve Entrapment
- Keywords
- Peroneal nerve, Neurolysis, Conservative treatment, Randomised controlled trial, Foot drop
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Belgian Health Care Knowledge Centre (KCE)
- Study start
- 28 Apr 2021 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective Multi-center Randomized Parallel-group
| Arm | Type | Receives |
|---|---|---|
| Conservative treatment | Active comparator | Other: Maximal physiotherapyPatients that are randomized to the conservative arm of the trial. These patients will not be operated until primary endpoint is reached. If necessary, cross-over can occur after primary endpoint is reached. Conservative treatment is considered standard of care. |
| Surgical treatment | Active comparator | Procedure: Neurolysis peroneal nervePatients randomized to the surgical arm will be operated within 1 week after randomization (if possible within 2 days). Neurolysis is considered standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurolysis peroneal nerveThe surgical approach for entrapment at the fibular head is usually through a curvilinear incision just distal to the fibular head. The subcutaneous tissue is bluntly dissected, and the common peroneal nerve is identified proximal to the peroneus longus muscle. The peroneal nerve is then released from the surrounding fibrous tissue and fascia. The nerve is decompressed distally as it dives under the peroneus longus muscle. The decompression at this site is essential. Certain authors state that an adequate decompression should extend beyond the bifurcation in the deep and superficial peroneal nerve and should involve cutting the intermuscular septa | Procedure or surgery | Surgical treatment |
| Maximal physiotherapyMobilization of ankle and foot, stretching of the calf muscles (prevention of contractures) Tonification of the dorsiflexion- and eversion muscles of the ankle Proprioceptive training Gait rehabilitation Home exercise schedule | Other | Conservative treatment |
Primary outcome
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.
16 secondary outcomes
Time to recovery
Time frame: 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).
Time frame: 10 days (surgery), 6 weeks, 3 months, 6 months, 9 months and 18 months (after randomization))
Ankle dorsiflexion strength as measured by isometric dynamometry.
Time frame: 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
Time frame: 10 days (surgery), 6 weeks, 3 months, 6 months, 9 months and 18 months (after randomization))
Complications and neurologic deficits: Sensory changes
Time frame: 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
Time frame: 6 weeks, 3 months, 6 months and 18 months (after randomization)
Gait assessment: Stanmore questionnaire
Time frame: 6 weeks, 3 months, 6 months, 9 months and 18 months (after randomization)
Gait assessment: Functional ambulation categories
Time frame: 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
Time frame: 6 weeks, 3 months, 6 months, 9 months and 18 months (after randomization)
Health economic assessment: Work Productivity and Activity Impairment Questionnaire (WPAI)
Time frame: 6 weeks and 6 months after randomization
Complications and neurologic deficits: Surgical complications
Time frame: 10 days, 6 weeks and 18 months after surgery
Electrodiagnostics: evolution of conduction block at the level of the fibular head
Time frame: 3 months and 9 months after randomization.
Patient-reported outcome measurements regarding health-related quality of life: 5 Level Euro Quality of Life 5 Dimensions (EQ5D-5L)
Time frame: 10 days (surgery), 6 weeks, 3 months, 6 months, 9 months and 18 months (after randomization)
Health economic assessment: Return to work
Time frame: 6 weeks
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
Time frame: 9 months after randomization
Complications and neurologic deficits: Motor changes as assessed by the Medical Research Council Score (MRC-score) for ankle eversion
Time frame: 10 days (surgery), 6 weeks, 3 months, 6 months, 9 months and 18 months (after randomization)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Background: PubMed 26700629Poage C, Roth C, Scott B. Peroneal Nerve Palsy: Evaluation and Management. J Am Acad Orthop Surg. 2016 Jan;24(1):1-10. doi: 10.5435/JAAOS-D-14-00420.
- Background: PubMed 29961126Broekx S, Weyns F. External neurolysis as a treatment for foot drop secondary to weight loss: a retrospective analysis of 200 cases. Acta Neurochir (Wien). 2018 Sep;160(9):1847-1856. doi: 10.1007/s00701-018-3614-9. Epub 2018 Jul 1.
- Background: PubMed 10905469Cruz-Martinez A, Arpa J, Palau F. Peroneal neuropathy after weight loss. J Peripher Nerv Syst. 2000 Jun;5(2):101-5. doi: 10.1046/j.1529-8027.2000.00007.x.
- Background: PubMed 26974980Khedr EM, Fawi G, Allah Abbas MA, El-Fetoh NA, Zaki AF, Gamea A. Prevalence of Common Types of Compression Neuropathies in Qena Governorate/Egypt: A Population-Based Survey. Neuroepidemiology. 2016;46(4):253-60. doi: 10.1159/000444641. Epub 2016 Mar 15.
- Background: PubMed 23146298Kandil MR, Darwish ES, Khedr EM, Sabry MM, Abdulah MA. A community-based epidemiological study of peripheral neuropathies in Assiut, Egypt. Neurol Res. 2012 Dec;34(10):960-6. doi: 10.1179/1743132812Y.0000000099.
- Background: PubMed 25942176Poppler LH, Bansal A, Groves A, Sacks G, Davidge K, Mackinnon SE. Abstract 65: Subclinical Peroneal Nerve Entrapment May be an Under-recognized Cause of Falls in Hospitalized Patients. Plast Reconstr Surg. 2014 Mar;133(3 Suppl):76. doi: 10.1097/01.prs.0000445098.29964.cf. No abstract available.
- Background: PubMed 16221285Aprile I, Caliandro P, La Torre G, Tonali P, Foschini M, Mondelli M, Bertolini C, Piazzini DB, Padua L. Multicenter study of peroneal mononeuropathy: clinical, neurophysiologic, and quality of life assessment. J Peripher Nerv Syst. 2005 Sep;10(3):259-68. doi: 10.1111/j.1085-9489.2005.10304.x.
- Background: PubMed 11441574Aprile I, Padua L, Padua R, D'Amico P, Meloni A, Caliandro P, Pauri F, Tonali P. Peroneal mononeuropathy: predisposing factors, and clinical and neurophysiological relationships. Neurol Sci. 2000 Dec;21(6):367-71. doi: 10.1007/s100720070052.
- Background: PubMed 19153647Aprile I, Tonali P, Caliandro P, Pazzaglia C, Foschini M, Di Stasio E, Mondelli M, Padua L; Italian CTS and other entrapments Study Group. Italian multicentre study of peroneal mononeuropathy: multiperspective follow-up. Neurol Sci. 2009 Feb;30(1):37-44. doi: 10.1007/s10072-009-0010-5. Epub 2009 Jan 20.
- Background: PubMed 17868251Aprile I, Caliandro P, Foschini M, Di Stasio E, Padua L; Italian CTS and other Entrapments Study Group; Mondelli M. Multicentre study of peroneal mononeuropathy: multiperspective follow-up of nonsurgical cases. J Peripher Nerv Syst. 2007 Sep;12(3):232-3. doi: 10.1111/j.1529-8027.2007.00145.x. No abstract available.
- Background: PubMed 1011026Berry H, Richardson PM. Common peroneal nerve palsy: a clinical and electrophysiological review. J Neurol Neurosurg Psychiatry. 1976 Dec;39(12):1162-71. doi: 10.1136/jnnp.39.12.1162.
- Background: PubMed 23530751Bsteh G, Wanschitz JV, Gruber H, Seppi K, Loscher WN. Prognosis and prognostic factors in non-traumatic acute-onset compressive mononeuropathies--radial and peroneal mononeuropathies. Eur J Neurol. 2013 Jun;20(6):981-5. doi: 10.1111/ene.12150. Epub 2013 Mar 26.
- Individual participant dataSharing planned: No
Related trials for Peroneal Nerve Entrapment
Not yet recruitingPhase 2
NAC-REPAIR for Post-surgical Pain
Carpal Tunnel Surgery, Trigger Finger Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tom Theys, M.D.; Ph.D. principal investigator
Univeristy hospitals of Leuven
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurolysis peroneal nerve and Maximal physiotherapy in people with Peroneal Nerve Entrapment, run by Universitaire Ziekenhuizen KU Leuven at 18 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christophe Oosterbos, M.D. (+3216344290, christopheoosterbos@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04695834, which also lists 31 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2024.