Treatment for Ulnar Neuropathy at the Elbow (UNETREAT)

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

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Nervous System Diseases; Nerve Compression Syndromes; Cubital Tunnel Syndrome
• Intervention / Treatment: Behavioral: Conservative treatment; Procedure: Simple decompression of the ulnar nerve

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.

• Study Type: Interventional
• Enrollment (Actual): 138
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • University Medical Center Ljubljana, Department of Neurology, Institute of Clinical Neurophysiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: UNE by CTE_surgery; Patients with UNE by CTE randomly distributed for simple decompression of the ulnar nerve. Patients will also receive pictured recommendations with descriptions, which limb positions should be avoided. Control neurological examination will be performed every 3 months and identical protocol as at the time of diagnostic evaluation at 1 year follow-up.	Behavioral: Conservative treatment; Patients will be given pictured recommendations with descriptions, which limb positions should be avoided.; Procedure: Simple decompression of the ulnar nerve; Surgical release 2-3 cm distal to medial epicondyle with minimal-incision technique .
Active Comparator: UNE by CTE_conservative treatment; Patients with UNE by CTE randomly distributed for conservative treatment. Patients will receive pictured recommendations with descriptions, which limb positions should be avoided. In order to prevent deterioration in conservatively treated group of patients with UNE by CTE control neurological examination will be performed every 3 months. Criteria for surgical release will be clinical deterioration or lack of clinical improvement after 12 months. Prior to surgical release and at 1 year follow-up identical protocol as at the time of diagnostic evaluation will be performed.	Behavioral: Conservative treatment; Patients will be given pictured recommendations with descriptions, which limb positions should be avoided.
Experimental: UNE at RCC_surgery; Patients with UNE at RCC randomly distributed for simple decompression of the ulnar nerve. Patients will also receive pictured recommendations with descriptions, which limb positions should be avoided. At 1 year follow-up identical protocol as at the time of diagnostic evaluation will be performed.	Behavioral: Conservative treatment; Patients will be given pictured recommendations with descriptions, which limb positions should be avoided.; Procedure: Simple decompression of the ulnar nerve; Surgical release 2-3 cm distal to medial epicondyle with minimal-incision technique .
Active Comparator: UNE at RCC_conservative treatment; Patients with UNE at RCC randomly distributed for conservative treatment. Patients will receive pictured recommendations with descriptions, which limb positions should be avoided. At 1 year follow-up identical protocol as at the time of diagnostic evaluation will be performed.	Behavioral: Conservative treatment; Patients will be given pictured recommendations with descriptions, which limb positions should be avoided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
UNEQ Score	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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical UNE Severity	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.	1 years
Muscle Wasting	The percentage of patients with reduction in ulnar-innervated hand muscle atrophy	1 years
Muscles Strength	The percentage of patients with increased ADM/FDI muscle MRC grade	1 years
Light Touch 5th Finger	Light touch sensation on the tip of the 5th finger as 0 - normal, 1 - moderately reduced, 2 - severely reduced or 3 - absent	1 year
Ulnar_MNCV	The percentage of patients with >30% increase in MNCVmin	1 years
Ulnar_CMAP_AMP	The amplitude of the ulnar CMAP on stimulation at D4	1 years
Ulnar_SNAP_AMP	The amplitude of the ulnar SNAP from the 5th finger	1 year
Ulnar Nerve CSAmax	ulnar nerve CSAmax in the elbow segment	1 year
Ulnar Nerve CSAmin	Ulnar nerve CSAmin in the elbow segment	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle wasting_subjective	Percentage of patients without hand muscle wasting	2 years
Muscle wasting_objective	Cross section area of the first dorsal interosseous (FDI) muscle measured by ultrasonography (US)	2 years
Muscles strength_subjective	Percentage of patients with near normal (4+/5 on MRC) or normal (5/5 on MRC) ulnar hand muscles strength	2 years
Muscles strength_objective	Improvement in strength of the first dorsal interosseous (FDI) muscle as measured by dynamometer (microFET2)	2 years
Ulnar_CMAP_AMP	Increase in amplitude (AMP) of the ulnar compound muscle action potential (CMAP)	2 years
Ulnar_MNCV	Increase of motor nerve conduction velocity (MNCV) in the most affected 2 cm segment	2 years

Collaborators and Investigators

• Sponsor: University Medical Centre Ljubljana
• Collaborators: Slovenian Research Agency
• Investigators: Principal Investigator: Simon Podnar, MD, DSc, Department of Neurology, University Medical Center Ljubljana

Publications and helpful links

General Publications

• Omejec G, Podnar S. Precise localization of ulnar neuropathy at the elbow. Clin Neurophysiol. 2015 Dec;126(12):2390-6. doi: 10.1016/j.clinph.2015.01.023. Epub 2015 Feb 14.
• Omejec G, Podnar S. What causes ulnar neuropathy at the elbow? Clin Neurophysiol. 2016 Jan;127(1):919-924. doi: 10.1016/j.clinph.2015.05.027. Epub 2015 Jun 17.
• Simon NG. Treatment of ulnar neuropathy at the elbow - An ongoing conundrum. Clin Neurophysiol. 2018 Aug;129(8):1716-1717. doi: 10.1016/j.clinph.2018.06.006. Epub 2018 Jun 18. No abstract available.
• Omejec G, Podnar S. Long-term outcomes in patients with ulnar neuropathy at the elbow treated according to the presumed aetiology. Clin Neurophysiol. 2018 Aug;129(8):1763-1769. doi: 10.1016/j.clinph.2018.04.753. Epub 2018 Jun 1.
• Omejec G, Zgur T, Podnar S. Diagnostic accuracy of ultrasonographic and nerve conduction studies in ulnar neuropathy at the elbow. Clin Neurophysiol. 2015 Sep;126(9):1797-804. doi: 10.1016/j.clinph.2014.12.001. Epub 2014 Dec 8.
• Omejec G, Podnar S. Normative values for short-segment nerve conduction studies and ultrasonography of the ulnar nerve at the elbow. Muscle Nerve. 2015 Mar;51(3):370-7. doi: 10.1002/mus.24328. Epub 2015 Jan 10.
• Omejec G, Podnar S. Proposal for electrodiagnostic evaluation of patients with suspected ulnar neuropathy at the elbow. Clin Neurophysiol. 2016 Apr;127(4):1961-7. doi: 10.1016/j.clinph.2016.01.011. Epub 2016 Jan 28.
• Omejec G, Zgur T, Podnar S. Can neurologic examination predict pathophysiology of ulnar neuropathy at the elbow? Clin Neurophysiol. 2016 Oct;127(10):3259-64. doi: 10.1016/j.clinph.2016.08.002. Epub 2016 Aug 9.
• Omejec G, Bozikov K, Podnar S. Validation of preoperative nerve conduction studies by intraoperative studies in patients with ulnar neuropathy at the elbow. Clin Neurophysiol. 2016 Dec;127(12):3499-3505. doi: 10.1016/j.clinph.2016.09.018. Epub 2016 Oct 13.
• Omejec G, Podnar S. Neurologic examination and instrument-based measurements in the evaluation of ulnar neuropathy at the elbow. Muscle Nerve. 2018 Jun;57(6):951-957. doi: 10.1002/mus.26046. Epub 2018 Jan 23.
• Podnar S, Omejec G, Bodor M. Nerve conduction velocity and cross-sectional area in ulnar neuropathy at the elbow. Muscle Nerve. 2017 Dec;56(6):E65-E72. doi: 10.1002/mus.25655. Epub 2017 Apr 15.
• Leis AA, Smith BE, Kosiorek HE, Omejec G, Podnar S. Complete dislocation of the ulnar nerve at the elbow: a protective effect against neuropathy? Muscle Nerve. 2017 Aug;56(2):242-246. doi: 10.1002/mus.25483. Epub 2017 Jan 4.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: August 27, 2018
• First Submitted That Met QC Criteria: August 27, 2018
• First Posted (Actual): August 29, 2018

Study Record Updates

• Last Update Posted (Actual): August 14, 2025
• Last Update Submitted That Met QC Criteria: August 12, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Treatment; Surgery; Electromyography; Ultrasonography; Conservative treatment; Ulnar neuropathy at the elbow
• Additional Relevant MeSH Terms: Wounds and Injuries; Pathologic Processes; Neuromuscular Diseases; Genetic Diseases, Inborn; Disease; Neurodegenerative Diseases; Congenital Abnormalities; Heredodegenerative Disorders, Nervous System; Nervous System Malformations; Polyneuropathies; Mononeuropathies; Cumulative Trauma Disorders; Sprains and Strains; Ulnar Nerve Compression Syndromes; Syndrome; Peripheral Nervous System Diseases; Nervous System Diseases; Charcot-Marie-Tooth Disease; Nerve Compression Syndromes; Hereditary Sensory and Motor Neuropathy; Cubital Tunnel Syndrome; Ulnar Neuropathies
• Other Study ID Numbers: UNE Treatment

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial, after de-identification.
• IPD Sharing Time Frame: Already available, no end date.
• IPD Sharing Access Criteria: Anyone who wishes to access the data
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No