Treatment for Ulnar Neuropathy at the Elbow

Not Applicable

Completed

Conditions: Peripheral Nervous System Diseases
Cubital Tunnel Syndrome
Nerve Compression Syndromes

Registration Number: NCT03651609

Lead Sponsor: University Medical Centre Ljubljana

Brief 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.

Detailed Description: Ulnar neuropathy at the elbow (UNE) is the second most common focal neuropathy with annual incidence rate of 21 per 100.000. Therefore, in Slovenia UNE each year affects approximately 420 and in Europe 156.000 patients. In previous publications evidence was presented that idiopathic UNE consists of two conditions occurring 2-5 cm apart. In the first condition, affecting about 15% of UNE patients, the ulnar nerve is entrapped 2-3 cm distal to the medial epicondyle (ME) in the cubital tunnel (CTE). In the second condition, affecting the majority (about 85%) of patients, the lesion is located at the ME or up to 4 cm proximally in the retrocondylar groove (RCC). As no anatomical structure constricting the ulnar nerve is usually found in that segment, the most probable cause of UNE at this location is extrinsic ulnar nerve compression against the underlying bone. The investigators believe that these two groups of UNE patients need different therapeutic approaches: (1) surgical release for ulnar nerve entrapment distal to ME and (2) conservative treatment for extrinsic nerve compression in the RCC. The efficiency of this therapeutic approach was already evaluated and significant clinical improvement was found in 80% of UNE patients. However, the design of that study did not enable to obtain an indisputable evidence that outcome was a result of treatment approach. It is still possible that improvement observed in patient population was a consequence of natural history rather than therapy. To resolve this problem a properly designed randomized control trial is needed. The investigators believe such trial would prevent numerous unnecessary and delayed operations in UNE patients.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 138

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).

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
UNEQ Score	1 year	The primary outcome measure was the change in standard questionnaire for assessment of UNE severity (UNEQ) score from baseline at inclusion of patients into the study and at 12-month follow-up. The UNEQ considers the patient's numbness and tingling of the last two fingers, elbow pain, and changes in these symptoms with elbow position. It also evaluates hand weakness. Questionnaire items were graded as: 1 - absent, 2 - mild, 3 - moderate, 4 - severe, or 5 - very severe. The final UNEQ score was calculated as the mean of the nine items.

Secondary Outcome Measures

Name	Time	Method
Clinical UNE Severity	1 years	Clinical UNE severity was graded: (1) Mild UNE - reduced sensation in the ulnar-innervated areas; (2) Moderate UNE - + ulnar hand muscle weakness, and (3) Severe UNE - + at least moderate ulnar hand muscle atrophy.
Muscle Wasting	1 years	The percentage of patients with reduction in ulnar-innervated hand muscle atrophy
Ulnar_MNCV	1 years	The percentage of patients with \>30% increase in MNCVmin
Muscles Strength	1 years	The percentage of patients with increased ADM/FDI muscle MRC grade
Light Touch 5th Finger	1 year	Light touch sensation on the tip of the 5th finger as 0 - normal, 1 - moderately reduced, 2 - severely reduced or 3 - absent
Ulnar_CMAP_AMP	1 years	The amplitude of the ulnar CMAP on stimulation at D4
Ulnar_SNAP_AMP	1 year	The amplitude of the ulnar SNAP from the 5th finger
Ulnar Nerve CSAmax	1 year	ulnar nerve CSAmax in the elbow segment
Ulnar Nerve CSAmin	1 year	Ulnar nerve CSAmin in the elbow segment

Trial Locations

Locations (1): University Medical Center Ljubljana, Department of Neurology, Institute of Clinical Neurophysiology
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Ljubljana, Slovenia
University Medical Center Ljubljana, Department of Neurology, Institute of Clinical Neurophysiology
🇸🇮Ljubljana, Slovenia