Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Slovenian Research Agency | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UNE by CTE_surgery | Experimental | 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. |
|
| UNE by CTE_conservative treatment | Active Comparator | 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. |
|
| UNE at RCC_surgery | Experimental | 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. |
|
| UNE at RCC_conservative treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simple decompression of the ulnar nerve | Procedure | Surgical release 2-3 cm distal to medial epicondyle with minimal-incision technique . |
|
| Measure | Description | Time Frame |
|---|---|---|
| UNEQ Score | The primary outcome measure was the change in standard questionnaire for assessment of UNE severity (UNEQ) score from baseline at inclusion of patients into the study and at 12-month follow-up. The UNEQ considers the patient's numbness and tingling of the last two fingers, elbow pain, and changes in these symptoms with elbow position. It also evaluates hand weakness. Questionnaire items were graded as: 1 - absent, 2 - mild, 3 - moderate, 4 - severe, or 5 - very severe. The final UNEQ score was calculated as the mean of the nine items. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical UNE Severity | Clinical UNE severity was graded: (1) Mild UNE - reduced sensation in the ulnar-innervated areas; (2) Moderate UNE - + ulnar hand muscle weakness, and (3) Severe UNE - + at least moderate ulnar hand muscle atrophy. | 1 years |
| Muscle Wasting |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Simon Podnar, MD, DSc | Department of Neurology, University Medical Center Ljubljana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Ljubljana, Department of Neurology, Institute of Clinical Neurophysiology | Ljubljana | 1000 | Slovenia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25743266 | Background | 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. | |
| 26093933 | Background | 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. |
Not provided
Not provided
All of the individual participant data collected during the trial, after de-identification.
Already available, no end date.
Anyone who wishes to access the data
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. Simple decompression of the ulnar nerve: Surgical release 2-3 cm distal to medial epicondyle with minimal-incision technique . Conservative treatment: Patients will be given pictured recommendations with descriptions, which limb positions should be avoided. |
| FG001 | 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. Conservative treatment: Patients will be given pictured recommendations with descriptions, which limb positions should be avoided. |
| FG002 | UNE at RGC_surgery | Patients with UNE at RGC 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. Simple decompression of the ulnar nerve: Surgical release 2-3 cm distal to medial epicondyle with minimal-incision technique . Conservative treatment: Patients will be given pictured recommendations with descriptions, which limb positions should be avoided. |
| FG003 | UNE at RGC_conservative Treatment | Patients with UNE at RGC 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. Conservative treatment: Patients will be given pictured recommendations with descriptions, which limb positions should be avoided. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. Simple decompression of the ulnar nerve: Surgical release 2-3 cm distal to medial epicondyle with minimal-incision technique . Conservative treatment: Patients will be given pictured recommendations with descriptions, which limb positions should be avoided. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | UNEQ Score | The primary outcome measure was the change in standard questionnaire for assessment of UNE severity (UNEQ) score from baseline at inclusion of patients into the study and at 12-month follow-up. The UNEQ considers the patient's numbness and tingling of the last two fingers, elbow pain, and changes in these symptoms with elbow position. It also evaluates hand weakness. Questionnaire items were graded as: 1 - absent, 2 - mild, 3 - moderate, 4 - severe, or 5 - very severe. The final UNEQ score was calculated as the mean of the nine items. | Posted | Median | Inter-Quartile Range | score on a scale | 1 year |
|
2 years
Patients reported adverse events at follow-ups. Additionally, principal investigator's phone number was given.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Simple decompression of the ulnar nerve: Surgical release 2-3 cm distal to medial epicondyle with minimal-incision technique . Conservative treatment: Patients will be given pictured recommendations with descriptions, which limb positions should be avoided. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gregor | Institute of Clinical Neurophysiology, Division of Neurology, University Medical Centre Ljubljana, Slovenia | +38631226546 | gregor.omejec@kclj.si |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 3, 2019 | Aug 12, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D020430 | Cubital Tunnel Syndrome |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D020424 | Ulnar Neuropathies |
| D020422 | Mononeuropathies |
Not provided
Not provided
| ID | Term |
|---|---|
| D000072700 | Conservative Treatment |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
The study will have a parallel trial design with a 1:1 allocation ratio. CTE and RCC patients will be separately randomized throwing dice as follows: (1) even number - surgical release; and (2) odd number - conservative treatment. In patients with bilateral UNE, the more affected arm will be randomized. Patients randomized to the surgical arm will be referred to a plastic surgeon. All included CTE and RCC patients (including those randomized to surgical release) will be given illustrated instructions showing arm positions to avoid to prevent further ulnar nerve damage. The examiners will be blinded as far as possible to the patient's study arm and to the findings of other parts of the evaluation. Patients will not be blinded to treatment.
Not provided
Not provided
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.
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. |
|
| Conservative treatment | Behavioral | Patients will be given pictured recommendations with descriptions, which limb positions should be avoided. |
|
The percentage of patients with reduction in ulnar-innervated hand muscle atrophy |
| 1 years |
| Muscles Strength | The percentage of patients with increased ADM/FDI muscle MRC grade | 1 years |
| Light Touch 5th Finger | Light touch sensation on the tip of the 5th finger as 0 - normal, 1 - moderately reduced, 2 - severely reduced or 3 - absent | 1 year |
| Ulnar_MNCV | The percentage of patients with >30% increase in MNCVmin | 1 years |
| Ulnar_CMAP_AMP | The amplitude of the ulnar CMAP on stimulation at D4 | 1 years |
| Ulnar_SNAP_AMP | The amplitude of the ulnar SNAP from the 5th finger | 1 year |
| Ulnar Nerve CSAmax | ulnar nerve CSAmax in the elbow segment | 1 year |
| Ulnar Nerve CSAmin | Ulnar nerve CSAmin in the elbow segment | 1 year |
| 29934265 | Background | 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. |
| 29887400 | Background | 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. |
| 25541522 | Background | 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. |
| 24985195 | Background | 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. |
| 26971477 | Background | 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. |
| 27552333 | Background | 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. |
| 27815973 | Background | 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. |
| 29266317 | Background | 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. |
| 28345147 | Background | 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. |
| 27859367 | Background | 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. |
| BG001 | 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. Conservative treatment: Patients will be given pictured recommendations with descriptions, which limb positions should be avoided. |
| BG002 | UNE at RCC_surgery | Patients with UNE at RGC 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. Simple decompression of the ulnar nerve: Surgical release 2-3 cm distal to medial epicondyle with minimal-incision technique . Conservative treatment: Patients will be given pictured recommendations with descriptions, which limb positions should be avoided. |
| BG003 | UNE at RCC_conservative Treatment | Patients with UNE at RGC 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. Conservative treatment: Patients will be given pictured recommendations with descriptions, which limb positions should be avoided. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Standard questionnaire for assessment of UNE severity (UNEQ) | Median | Inter-Quartile Range | units on a scale |
|
| OG001 | 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. Conservative treatment: Patients will be given pictured recommendations with descriptions, which limb positions should be avoided. |
| OG002 | UNE at RCC_surgery | Patients with UNE at RGC 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. Simple decompression of the ulnar nerve: Surgical release 2-3 cm distal to medial epicondyle with minimal-incision technique . Conservative treatment: Patients will be given pictured recommendations with descriptions, which limb positions should be avoided. |
| OG003 | UNE at RCC_conservative Treatment | Patients with UNE at RGC 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. Conservative treatment: Patients will be given pictured recommendations with descriptions, which limb positions should be avoided. |
|
|
| Secondary | Clinical UNE Severity | Clinical UNE severity was graded: (1) Mild UNE - reduced sensation in the ulnar-innervated areas; (2) Moderate UNE - + ulnar hand muscle weakness, and (3) Severe UNE - + at least moderate ulnar hand muscle atrophy. | Not Posted | Sep 2025 | 1 years | Participants |
| Secondary | Muscle Wasting | The percentage of patients with reduction in ulnar-innervated hand muscle atrophy | Not Posted | Sep 2025 | 1 years | Participants |
| Secondary | Muscles Strength | The percentage of patients with increased ADM/FDI muscle MRC grade | Not Posted | Sep 2025 | 1 years | Participants |
| Secondary | Light Touch 5th Finger | Light touch sensation on the tip of the 5th finger as 0 - normal, 1 - moderately reduced, 2 - severely reduced or 3 - absent | Not Posted | Sep 2025 | 1 year | Participants |
| Secondary | Ulnar_MNCV | The percentage of patients with >30% increase in MNCVmin | Not Posted | Sep 2025 | 1 years | Participants |
| Secondary | Ulnar_CMAP_AMP | The amplitude of the ulnar CMAP on stimulation at D4 | Not Posted | Sep 2025 | 1 years | Participants |
| Secondary | Ulnar_SNAP_AMP | The amplitude of the ulnar SNAP from the 5th finger | Not Posted | Sep 2025 | 1 year | Participants |
| Secondary | Ulnar Nerve CSAmax | ulnar nerve CSAmax in the elbow segment | Not Posted | Sep 2025 | 1 year | Participants |
| Secondary | Ulnar Nerve CSAmin | Ulnar nerve CSAmin in the elbow segment | Not Posted | Sep 2025 | 1 year | Participants |
| 0 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | 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. Conservative treatment: Patients will be given pictured recommendations with descriptions, which limb positions should be avoided. | 0 | 33 | 0 | 33 | 0 | 33 |
| EG002 | UNE at RGC_surgery | Patients with UNE at RGC 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. Simple decompression of the ulnar nerve: Surgical release 2-3 cm distal to medial epicondyle with minimal-incision technique . Conservative treatment: Patients will be given pictured recommendations with descriptions, which limb positions should be avoided. | 0 | 33 | 0 | 33 | 0 | 33 |
| EG003 | UNE at RGC_conservative Treatment | Patients with UNE at RGC 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. Conservative treatment: Patients will be given pictured recommendations with descriptions, which limb positions should be avoided. | 0 | 32 | 0 | 32 | 0 | 32 |
Not provided
Not provided
Not provided
| D017769 |
| Ulnar Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |