Treatment for Ulnar Neuropathy at the Elbow

Peripheral Nervous System Diseases Clinical Trial

— UNETREAT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03651609
• Other study ID #: UNE Treatment
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: September 1, 2023

Study information

• Verified date: March 2021
• Source: University Medical Centre Ljubljana
• Contact: Gregor Omejec, PT, DSc
• Phone: +386 1 522 1502
• Email: gregor.omejec[@]kclj.si
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 under the humeroulnar aponeurosis (HUA) surgical HUA release (simple decompression) is superior to conservative treatment. By contrast, in patients with UNE at the retroepicondylar (RTC) groove surgical HUA release (simple decompression) should not be superior to conservative treatment.

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) under the humeroulnar aponeurosis (HUA), i.e., in the cubital tunnel. 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 retroepicondylar (RTC) groove. 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 RTC groove. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• continuous numbness or paresthesias in the 5th ?nger,
• 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).

Related Conditions & MeSH terms

• Charcot-Marie-Tooth Disease
• Cubital Tunnel Syndrome
• Hereditary Sensory and Motor Neuropathy
• Nerve Compression Syndromes
• Nervous System Diseases
• Peripheral Nervous System Diseases
• Syndrome
• Ulnar Neuropathies

Intervention

Procedure:
• Simple decompression of the ulnar nerve
Surgical HUA release 2-3 cm distal to medial epicondyle with minimal-incision technique .

Behavioral:
• Conservative treatment
Patients will be given pictured recommendations with descriptions, which limb positions should be avoided.

Locations

Country	Name	City	State
Slovenia	University Medical Center Ljubljana, Department of Neurology, Institute of Clinical Neurophysiology	Ljubljana

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana	Slovenian Research Agency

Country where clinical trial is conducted

Slovenia, 

References & Publications (12)

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. — View Citation

Omejec G, Žgur 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. — View Citation

Omejec G, Žgur 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. — View Citation

Omejec G, Božikov 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Muscle wasting_subjective	Percentage of patients without hand muscle wasting	2 years
Other	Muscle wasting_objective	Cross section area of the first dorsal interosseous (FDI) muscle measured by ultrasonography (US)	2 years
Other	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
Other	Muscles strength_objective	Improvement in strength of the first dorsal interosseous (FDI) muscle as measured by dynamometer (microFET2)	2 years
Other	Ulnar_CMAP_AMP	Increase in amplitude (AMP) of the ulnar compound muscle action potential (CMAP)	2 years
Other	Ulnar_MNCV	Increase of motor nerve conduction velocity (MNCV) in the most affected 2 cm segment	2 years
Primary	Improvement/remission	Primary outcome of the study will be percentage of patients with at least moderate symptoms improvement or complete remission	2 years
Secondary	UNE symptoms	Percentage of patients without UNE symptoms or with minimal UNE symptoms	2 years