University Medical Center Ljubljana, Department of Neurology, Institute of Clinical Neurophysiology
Ljubljana, 1000, Slovenia
NCT Number: NCT03651609
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.
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Notify Me18 year–90 year
All sexes
Interventional
Not applicable
Ljubljana, 1000, Slovenia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Surgical release 2-3 cm distal to medial epicondyle with minimal-incision technique .
Patients will be given pictured recommendations with descriptions, which limb positions should be avoided.
Time frame: 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.
Time frame: 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.
Time frame: 1 years
The percentage of patients with reduction in ulnar-innervated hand muscle atrophy
Time frame: 1 years
The percentage of patients with increased ADM/FDI muscle MRC grade
Time frame: 1 year
Light touch sensation on the tip of the 5th finger as 0 - normal, 1 - moderately reduced, 2 - severely reduced or 3 - absent
Time frame: 1 years
The percentage of patients with >30% increase in MNCVmin
Time frame: 1 years
The amplitude of the ulnar CMAP on stimulation at D4
Time frame: 1 year
The amplitude of the ulnar SNAP from the 5th finger
Time frame: 1 year
ulnar nerve CSAmax in the elbow segment
Time frame: 1 year
Ulnar nerve CSAmin in the elbow segment
University Medical Centre Ljubljana
Other
Treatment for Ulnar Neuropathy at the Elbow - a Randomized Control Trial
Acronym: UNETREAT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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