A multicentre, randomized controlled trial of neurolysis for mild ulnar neuropathy at the elbow

Completed

• Conditions: nerve at elbow; ulnar neuropathy; 10034606

• Registration Number: NL-OMON34554
• Lead Sponsor: Sint Elisabeth Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 12 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

a. Age 18 years or more.
b. Clinical signs of an ulnar neuropathy (i.e., pain, numbness or paraesthesias in the area of the ulnar nerve, weakness or clumsiness of ulnar muscles).
c. Duration of symptoms < 9 months.
d. MRC sumscore of the flexor carpi ulnaris (FCU), flexor digitorum profundus digiti IV + V (FDP IV-V), abductor digiti minimi (ADM) and first dorsal interosseous I (FDI) muscles > 16 (of a maximum score of 4 x 5 = 20).
e. Electrophysiological * or sonographic ** evidence of localization of the lesion at the elbow.
f. Informed written consent.

Exclusion Criteria

a. evidence of a coexistent polyneuropathy.
b. History of hereditary neuropathy with liability to pressure palsies
c. Traumatic origin of UNE.
d. Malignancy.
e. Previous or current use of chemotherapy.
f. Unable to follow up

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>5.1.1 Main study parameter<br /><br>A. To evaluate the outcome patients will be asked to score the treatment result<br /><br>on a 6-point ordinal transition scale, which is subsequently dichotomized as<br /><br>'improved' (*completely recovered* or *much improved*) and 'not improved'<br /><br>(*slightly improved*, *no change*, *slightly worse*, *much worse*).<br /><br>The scores at 3 months will be used to evaluate short time effects and the<br /><br>score after 12 months will be used to evaluate long term effects</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>5.1.2 Secondary study parameters<br /><br>- VAS score for paresthesias<br /><br>- VAS score for pain at the hand<br /><br>- VAS score for numbness<br /><br>- Frequency of complications in the operated group<br /><br>- Number of patients that drop out in the conservative group because they<br /><br>needed surgery<br /><br>- Socio-economic parameters: work situation; sick leave, change in work/adapted<br /><br>function at work<br /><br>- Functional scales</p><br>