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Completed

NCT Number: NCT03651609

Treatment for Ulnar Neuropathy at the Elbow

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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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Ljubljana, Department of Neurology, Institute of Clinical Neurophysiology

Ljubljana, 1000, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Simple decompression of the ulnar nerve

Procedure

Surgical release 2-3 cm distal to medial epicondyle with minimal-incision technique .

Conservative treatment

Behavioral

Patients will be given pictured recommendations with descriptions, which limb positions should be avoided.

Primary outcomes

  1. UNEQ Score

    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.

Secondary outcomes

  1. Clinical UNE Severity

    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.

  2. Muscle Wasting

    Time frame: 1 years

    The percentage of patients with reduction in ulnar-innervated hand muscle atrophy

  3. Muscles Strength

    Time frame: 1 years

    The percentage of patients with increased ADM/FDI muscle MRC grade

  4. Light Touch 5th Finger

    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

  5. Ulnar_MNCV

    Time frame: 1 years

    The percentage of patients with >30% increase in MNCVmin

  6. Ulnar_CMAP_AMP

    Time frame: 1 years

    The amplitude of the ulnar CMAP on stimulation at D4

  7. Ulnar_SNAP_AMP

    Time frame: 1 year

    The amplitude of the ulnar SNAP from the 5th finger

  8. Ulnar Nerve CSAmax

    Time frame: 1 year

    ulnar nerve CSAmax in the elbow segment

  9. Ulnar Nerve CSAmin

    Time frame: 1 year

    Ulnar nerve CSAmin in the elbow segment

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Collaborators

  • Slovenian Research Agency

Registry information

Official study title

Treatment for Ulnar Neuropathy at the Elbow - a Randomized Control Trial

Acronym: UNETREAT

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Aug 29, 2018
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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