A prospective, multicenter, randomized, parallel-group controlled trial to compare conservative versus surgical treatment of foot drop in peroneal nerve entrapment.

Completed

• Conditions: compression of the peroneal nerve; peroneal neuropathy; 10034606; 10009720

• Registration Number: NL-OMON54026
• Lead Sponsor: niversitaire ziekenhuizen Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

1. 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
2. EDX-documented peroneal nerve entrapment with persisting (10 ± 4 weeks) foot
drop (MRC-score <= 3)
3. Imaging (ultrasound/MRI) performed to exclude a compressive mass
4. Age >= 18 years

Exclusion Criteria

1. Subjects with posttraumatic or iatrogenic peroneal nerve injury
2. Subjects with peroneal neuropathy due to a compressive mass (e.g. cyst,
tumour)
3. Peroneal nerve entrapment at other sites than the fibular head
4. Bilateral peroneal nerve entrapment
5. Patients with mental or physical problems that incapacitate them to
participate in a physiotherapy program
6. Psychiatric illness
7. Pregnancy
8. Planned (e)migration within 1 year after randomization to another country
9. Subjects with previous foot drop
10. Permanently bedridden subjects
11. 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, ankle sprain, *).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary research question of the trial is to assess whether foot drop,<br /><br>caused by peroneal nerve entrapment in adult patients* recovers better within 9<br /><br>months after decompressive surgery compared to prolonged standard conservative<br /><br>treatment.<br /><br><br /><br>The primary endpoint is the difference in distance covered in meters during the<br /><br>six-minute walk test (6MWD) between baseline and 9 months after randomization. </p><br>