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Treatment for Ulnar Neuropathy at the Elbow (UNETREAT)

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ClinicalTrials.gov Identifier: NCT03651609
Recruitment Status : Recruiting
First Posted : August 29, 2018
Last Update Posted : July 10, 2019
Sponsor:
Collaborator:
Slovenian Research Agency
Information provided by (Responsible Party):
Gregor Omejec, University Medical Centre Ljubljana

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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 : January 1, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2022


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.




Primary Outcome Measures :
  1. Improvement/remission [ Time Frame: 2 years ]
    Primary outcome of the study will be percentage of patients with at least moderate symptoms improvement or complete remission


Secondary Outcome Measures :
  1. UNE symptoms [ Time Frame: 2 years ]
    Percentage of patients without UNE symptoms or with minimal UNE symptoms


Other Outcome Measures:
  1. Muscle wasting_subjective [ Time Frame: 2 years ]
    Percentage of patients without hand muscle wasting

  2. Muscle wasting_objective [ Time Frame: 2 years ]
    Cross section area of the first dorsal interosseous (FDI) muscle measured by ultrasonography (US)

  3. Muscles strength_subjective [ Time Frame: 2 years ]
    Percentage of patients with near normal (4+/5 on MRC) or normal (5/5 on MRC) ulnar hand muscles strength

  4. Muscles strength_objective [ Time Frame: 2 years ]
    Improvement in strength of the first dorsal interosseous (FDI) muscle as measured by dynamometer (microFET2)

  5. Ulnar_CMAP_AMP [ Time Frame: 2 years ]
    Increase in amplitude (AMP) of the ulnar compound muscle action potential (CMAP)

  6. Ulnar_MNCV [ Time Frame: 2 years ]
    Increase of motor nerve conduction velocity (MNCV) in the most affected 2 cm segment



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03651609


Contacts
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Contact: Gregor Omejec, PT, DSc +386 1 522 1502 gregor.omejec@kclj.si
Contact: Simon Podnar, MD, DSc +386 1 522 3076 simon.podnar@kclj.si

Locations
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Slovenia
University Medical Center Ljubljana, Department of Neurology, Institute of Clinical Neurophysiology Recruiting
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
University Medical Centre Ljubljana
Slovenian Research Agency
Investigators
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Principal Investigator: Simon Podnar, MD, DSc Department of Neurology, University Medical Center Ljubljana

Publications:

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Responsible Party: Gregor Omejec, Principal Investigator, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT03651609     History of Changes
Other Study ID Numbers: UNE Treatment
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No planning to share individual participant data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gregor Omejec, University Medical Centre Ljubljana:
Ulnar neuropathy at the elbow
Electromyography
Ultrasonography
Treatment
Surgery
Conservative treatment

Additional relevant MeSH terms:
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Nerve Compression Syndromes
Charcot-Marie-Tooth Disease
Hereditary Sensory and Motor Neuropathy
Ulnar Nerve Compression Syndromes
Syndrome
Nervous System Diseases
Peripheral Nervous System Diseases
Cubital Tunnel Syndrome
Ulnar Neuropathies
Disease
Pathologic Processes
Neuromuscular Diseases
Mononeuropathies
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Nervous System Malformations
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Polyneuropathies
Congenital Abnormalities
Genetic Diseases, Inborn