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

Recruiting
Conditions
ulnar neuropathy, neurolysis, conservative treatmentulnaropathie, neurolyse, conservatief beleid
Registration Number
NL-OMON27989
Lead Sponsor
dr. L.H. VisserSt Elisabeth Hospitalhilvarenbeekseweg 605022 GC Tilburgthe Netherlands013-5392552Fax 013-5422538E-mail l.visser@elisabeth.nldr. R. BeekmanAtrium Medical CentrePo Box 4446 6401 CX Heerlen the Netherlandsr.beekman@atriummc.nl045-5766700drs. A.H.C.M.L. SchreuderAtrium Medical CentrePo Box 4446 6401 CX Heerlen the NetherlandsTSR01@atriummc.nl045-5766700
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
120
Inclusion Criteria

1. Age 18 years or more;

2. 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);

Exclusion Criteria

1. Evidence of a coexistent polyneuropathy;

2. History of hereditary neuropathy with liability to pressure palsies;

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The primary objective of this study is to compare the short-term and long-term efficacy of neurolysis and conservative strategy for relieving symptoms in mild cases of UNE.
Secondary Outcome Measures
NameTimeMethod
Secondary objectives:<br /><br>1. VAS score for paresthesias;<br /><br>2. VAS score for pain at the hand;<br /><br>3. VAS score for numbness;<br /><br>4. Frequency of adverse events ascribed to the therapy (e.g. surgery complications in the operated group);<br /><br>5. Number of patients that drop out because they needed surgery;<br /><br>6. Socio-economic parameters: work situation; sick leave, change in work / adapted function at work;<br /><br>7. Functional scales: SF-36 and McGill Pain questionnaire.<br /><br>
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