Trial Outcomes & Findings for Treatment for Ulnar Neuropathy at the Elbow (NCT NCT03651609)
NCT ID: NCT03651609
Last Updated: 2025-08-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
138 participants
Primary outcome timeframe
1 year
Results posted on
2025-08-14
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
34
|
33
|
36
|
35
|
|
Overall Study
COMPLETED
|
32
|
33
|
33
|
32
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
3
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment for Ulnar Neuropathy at the Elbow
Baseline characteristics by cohort
| Measure |
UNE by CTE_surgery
n=32 Participants
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.
|
UNE by CTE_conservative Treatment
n=33 Participants
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.
|
UNE at RCC_surgery
n=33 Participants
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.
|
UNE at RCC_conservative Treatment
n=32 Participants
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.
|
Total
n=130 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
106 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Age, Continuous
|
63 years
n=5 Participants
|
69 years
n=7 Participants
|
58 years
n=5 Participants
|
60 years
n=4 Participants
|
63 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
96 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
130 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
Slovenia
|
32 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
130 Participants
n=21 Participants
|
|
Standard questionnaire for assessment of UNE severity (UNEQ)
|
2.0 units on a scale
n=5 Participants
|
2.0 units on a scale
n=7 Participants
|
1.9 units on a scale
n=5 Participants
|
1.9 units on a scale
n=4 Participants
|
1.9 units on a scale
n=21 Participants
|
PRIMARY outcome
Timeframe: 1 yearThe 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.
Outcome measures
| Measure |
UNE by CTE_surgery
n=32 Participants
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.
|
UNE by CTE_conservative Treatment
n=33 Participants
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.
|
UNE at RCC_surgery
n=33 Participants
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.
|
UNE at RCC_conservative Treatment
n=32 Participants
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.
|
|---|---|---|---|---|
|
UNEQ Score
Baseline
|
2 score on a scale
Interval 1.8 to 2.3
|
2 score on a scale
Interval 1.8 to 2.2
|
1.9 score on a scale
Interval 1.8 to 2.0
|
1.9 score on a scale
Interval 1.8 to 2.0
|
|
UNEQ Score
12 monts
|
1.7 score on a scale
Interval 1.4 to 1.8
|
2 score on a scale
Interval 1.8 to 2.1
|
1.4 score on a scale
Interval 1.3 to 1.7
|
1.6 score on a scale
Interval 1.3 to 1.7
|
SECONDARY outcome
Timeframe: 1 yearsClinical 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearsThe percentage of patients with reduction in ulnar-innervated hand muscle atrophy
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearsThe percentage of patients with increased ADM/FDI muscle MRC grade
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearLight touch sensation on the tip of the 5th finger as 0 - normal, 1 - moderately reduced, 2 - severely reduced or 3 - absent
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearsThe percentage of patients with \>30% increase in MNCVmin
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearsThe amplitude of the ulnar CMAP on stimulation at D4
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearThe amplitude of the ulnar SNAP from the 5th finger
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearulnar nerve CSAmax in the elbow segment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearUlnar nerve CSAmin in the elbow segment
Outcome measures
Outcome data not reported
Adverse Events
UNE by CTE_surgery
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
UNE by CTE_conservative Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
UNE at RGC_surgery
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
UNE at RGC_conservative Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Gregor
Institute of Clinical Neurophysiology, Division of Neurology, University Medical Centre Ljubljana, Slovenia
Phone: +38631226546
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place