N/A
N=138
Treatment for Ulnar Neuropathy at the Elbow
Peripheral Nervous System Diseases · Nerve Compression Syndromes · Cubital Tunnel Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT03651609 ↗Enrolled (actual)
138
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: UNEQ Score — 2; 2; 1.9; 1.9 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Simple decompression of the ulnar nerve (Procedure); Conservative treatment (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Medical Centre Ljubljana
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY UNEQ Score |
2; 2; 1.9; 1.9; 1.7; 2 | — |
| SECONDARY Clinical UNE Severity |
— | — |
| SECONDARY Muscle Wasting |
— | — |
| SECONDARY Muscles Strength |
— | — |
| SECONDARY Light Touch 5th Finger |
— | — |
| SECONDARY Ulnar_MNCV |
— | — |
| SECONDARY Ulnar_CMAP_AMP |
— | — |
| SECONDARY Ulnar_SNAP_AMP |
— | — |
| SECONDARY Ulnar Nerve CSAmax |
— | — |
| SECONDARY Ulnar Nerve CSAmin |
— | — |
Summary
The purpose of the study is to investigate utility and appropriateness of treatment interventions taking into account the presumed mechanisms of two main varieties of ulnar neuropathy at the elbow (UNE). The investigators hypothesize that in patients with UNE by entrapment in the cubital tunnel (CTE) surgical release (simple decompression) is superior to conservative treatment. By contrast, in patients with UNE in the retrocondylar groove (RCC) surgical humero-ulnar apponeurosis (HUA) release (simple decompression) should not be superior to conservative treatment.
Eligibility Criteria
Inclusion Criteria
- continuous numbness or paresthesias in the 5th finger,
- weakness of the ulnar-innervated muscles or hand clumsiness.
Exclusion Criteria
- previous elbow fracture or surgery,
- polyneuropathy, symptoms of polyneuropathy, conditions causing polyneuropathy (e.g., diabetes) or multiple mononeuropathy,
- motor neuron disorders (e.g., monomelic amyotrophy, amyotrophic lateral sclerosis - ALS).
Data sourced from ClinicalTrials.gov (NCT03651609). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.