UNETREAT: Treatment for Ulnar Neuropathy at the Elbow

Sponsor

University Medical Centre Ljubljana (Other)

Overall Status

Recruiting

CT.gov ID

NCT03651609

Collaborator

Slovenian Research Agency (Other)

150

Enrollment

Location

Arms

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Nervous System Diseases Nerve Compression Syndromes Cubital Tunnel Syndrome	Procedure: Simple decompression of the ulnar nerve Behavioral: Conservative treatment	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

Single (Investigator)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2019

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: UNE at HUA_HUA release Patients with UNE under the HUA 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 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.
Active Comparator: UNE at HUA_conservative treatment Patients with UNE under the HUA 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 at HUA control neurological examination will be performed every 3 months. Criteria for surgical HUA release will be clinical deterioration or lack of clinical improvement after 12 months. Prior to surgical HUA 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 RTC_HUA release Patients with UNE in the RTC groove 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 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.
Active Comparator: UNE at RTC_conservative treatment Patients with UNE in the RTC groove 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.

Outcome Measures

Primary Outcome Measures

Improvement/remission [2 years]
Primary outcome of the study will be percentage of patients with at least moderate symptoms improvement or complete remission

Secondary Outcome Measures

UNE symptoms [2 years]
Percentage of patients without UNE symptoms or with minimal UNE symptoms

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).