Treatment for Ulnar Neuropathy at the Elbow

NCT ID: NCT03651609

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2023-03-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Simple decompression of the ulnar nerve

Intervention Type: PROCEDURE

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

Conservative treatment

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

Conservative treatment

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

Simple decompression of the ulnar nerve

Intervention Type: PROCEDURE

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

Conservative treatment

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

Conservative treatment

Intervention Type: BEHAVIORAL

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

Interventions

Simple decompression of the ulnar nerve

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

Intervention Type: PROCEDURE

Conservative treatment

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Slovenian Research Agency

OTHER

Sponsor Role: collaborator

University Medical Centre Ljubljana

OTHER

Sponsor Role: lead

Responsible Party

Gregor Omejec

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Simon Podnar, MD, DSc

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, University Medical Center Ljubljana

Locations

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

Ljubljana, , Slovenia

Countries

Slovenia

References

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.

Reference Type: BACKGROUND

PMID: 25743266 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26093933 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29934265 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29887400 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25541522 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24985195 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26971477 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27552333 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27815973 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29266317 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28345147 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27859367 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

UNE Treatment

Identifier Type: -

Identifier Source: org_study_id