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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON34554
Enrollment
120
Registered
2006-08-15
Start date
2006-10-01
Completion date
Unknown
Last updated
2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

nerve at elbow ulnar neuropathy

Interventions

4.1 Surgical treatment Surgical treatment of ulnar neuropathy will be simple decompression. In this procedure a 6 to 8 cm curvilinear incision is made, overlying the course of the ulnar nerve as it

Sponsors

Sint Elisabeth Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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 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

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

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)