Clinical trial NCT03651609: Treatment for Ulnar Neuropathy at the Elbow
Official title: Treatment for Ulnar Neuropathy at the Elbow - a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Nervous System Diseases
Nerve Compression Syndromes
Cubital Tunnel Syndrome
Keywords: Ulnar neuropathy at the elbow
Electromyography
Ultrasonography
Treatment
Surgery
Conservative treatment
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
Collaborators: name: Slovenian Research Agency
First posted: 2018-08-29
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with suspected UNE will be prospectively recruited in a single secondary referral center. First of three blinded examiners will obtain patients' history and perform focused neurological examination. The second examiner will perform electrodiagnostic (EDx) and the third ultrasonographic (US) studies. Patients with UNE under the HUA and in the RTC groove will be randomly distributed in two groups for surgical HUA release and conservative treatment. During surgical intervention the surgeon will cut the HUA with minimal incision technique. All patients (including surgically treated) will be given pictured recommendations with descriptions, which limb positions should be avoided. In order to prevent deterioration in conservatively treated group of patients with UNE at HUA, control neurological examination will be performed every 3 months. At 1 year follow-up we will use identical protocol as at the time of initial diagnostic evaluation.
Primary purpose: TREATMENT

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 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.

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) 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.

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).

Primary outcomes:
measure: Improvement/remission
timeFrame: 2 years
Secondary outcomes:
measure: UNE symptoms
timeFrame: 2 years
Other outcomes:
measure: Muscle wasting_subjective
timeFrame: 2 years
measure: Muscle wasting_objective
timeFrame: 2 years
measure: Muscles strength_subjective
timeFrame: 2 years
measure: Muscles strength_objective
timeFrame: 2 years
measure: Ulnar_CMAP_AMP
timeFrame: 2 years
measure: Ulnar_MNCV
timeFrame: 2 years
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Center Ljubljana, Department of Neurology, Institute of Clinical Neurophysiology
Study officials:
affiliation: Department of Neurology, University Medical Center Ljubljana
name: Simon Podnar, MD, DSc
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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. No abstract available.
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.
citation: 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.
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.
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.
citation: 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.
citation: 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.
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.
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.
citation: 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.