Treatment for Ulnar Neuropathy at the Elbow

NCT03651609 | Completed Results

• 1 other identifier: UNE Treatment
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Nervous System Diseases; Nerve Compression Syndromes; Cubital Tunnel Syndrome

Keywords

Ulnar neuropathy at the elbow; Electromyography; Ultrasonography; Treatment; Surgery; Conservative treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Clinical UNE Severity

  1 years

• Muscle Wasting

  1 years

• Muscles Strength

  1 years

• Light Touch 5th Finger

  1 year

• Ulnar_MNCV

  1 years

Study Arms (4)

UNE by CTE_surgery

EXPERIMENTAL

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.

Procedure: Simple decompression of the ulnar nerve; Behavioral: Conservative treatment

UNE by CTE_conservative treatment

ACTIVE COMPARATOR

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

UNE at RCC_surgery

EXPERIMENTAL

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.

Procedure: Simple decompression of the ulnar nerve; Behavioral: Conservative treatment

UNE at RCC_conservative treatment

ACTIVE COMPARATOR

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

Interventions

Simple decompression of the ulnar nerve PROCEDURE

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

UNE at RCC_surgery; UNE by CTE_surgery

Conservative treatment BEHAVIORAL

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

UNE at RCC_conservative treatment; UNE at RCC_surgery; UNE by CTE_conservative treatment; UNE by CTE_surgery

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• continuous numbness or paresthesias in the 5th finger,
• weakness of the ulnar-innervated muscles or hand clumsiness.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead
• Slovenian Research Agency: collaborator

Study Sites (1)

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

Ljubljana, 1000, Slovenia

Location

Related Publications (12)

• 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.

  PMID: 25743266 BACKGROUND

• 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.

  PMID: 26093933 BACKGROUND

• 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.

  PMID: 29934265 BACKGROUND

• 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.

  PMID: 29887400 BACKGROUND

• 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.

  PMID: 25541522 BACKGROUND

• 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.

  PMID: 24985195 BACKGROUND

• 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.

  PMID: 26971477 BACKGROUND

• 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.

  PMID: 27552333 BACKGROUND

• 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.

  PMID: 27815973 BACKGROUND

• 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.

  PMID: 29266317 BACKGROUND

• 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.

  PMID: 28345147 BACKGROUND

• 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.

  PMID: 27859367 BACKGROUND

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Nerve Compression Syndromes; Cubital Tunnel Syndrome

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Ulnar Neuropathies; Mononeuropathies; Ulnar Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Gregor
• Organization: Institute of Clinical Neurophysiology, Division of Neurology, University Medical Centre Ljubljana, Slovenia

gregor.omejec@kclj.si

+38631226546

Study Officials

• Simon Podnar, MD, DSc

  Department of Neurology, University Medical Center Ljubljana

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Three examiners will perform one part of diagnostic evaluation that will include: (1) patients' history and focused neurological examination, (2) (EDx) and (3) US studies. They will be blinded to the findings of the other parts of the evaluation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study will have a parallel trial design with a 1:1 allocation ratio. CTE and RCC patients will be separately randomized throwing dice as follows: (1) even number - surgical release; and (2) odd number - conservative treatment. In patients with bilateral UNE, the more affected arm will be randomized. Patients randomized to the surgical arm will be referred to a plastic surgeon. All included CTE and RCC patients (including those randomized to surgical release) will be given illustrated instructions showing arm positions to avoid to prevent further ulnar nerve damage. The examiners will be blinded as far as possible to the patient's study arm and to the findings of other parts of the evaluation. Patients will not be blinded to treatment.

Study Record Dates

• First Submitted: August 27, 2018
• First Posted: August 29, 2018
• Study Start: January 1, 2019
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: August 14, 2025
• Results First Posted: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Already available, no end date.
• Access Criteria: Anyone who wishes to access the data

Locations

SL (1)