Cubital Tunnel Syndrome, Nerve Compression Syndromes, Peripheral Nervous System Diseases
Conditions
Keywords
Ulnar neuropathy at the elbow, Electromyography, Ultrasonography, Treatment, Surgery, Conservative 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 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.
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) 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.
Interventions
PROCEDURESimple decompression of the ulnar nerve
Surgical release 2-3 cm distal to medial epicondyle with minimal-incision technique .
BEHAVIORALConservative treatment
Patients will be given pictured recommendations with descriptions, which limb positions should be avoided.
Sponsors
Slovenian Research Agency
University Medical Centre Ljubljana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| UNEQ Score | 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscle Wasting | 1 years | The percentage of patients with reduction in ulnar-innervated hand muscle atrophy |
| Muscles Strength | 1 years | The percentage of patients with increased ADM/FDI muscle MRC grade |
| Light Touch 5th Finger | 1 year | Light touch sensation on the tip of the 5th finger as 0 - normal, 1 - moderately reduced, 2 - severely reduced or 3 - absent |
| Ulnar_MNCV | 1 years | The percentage of patients with \>30% increase in MNCVmin |
| Clinical UNE Severity | 1 years | 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. |
| Ulnar_SNAP_AMP | 1 year | The amplitude of the ulnar SNAP from the 5th finger |
| Ulnar Nerve CSAmax | 1 year | ulnar nerve CSAmax in the elbow segment |
| Ulnar Nerve CSAmin | 1 year | Ulnar nerve CSAmin in the elbow segment |
| Ulnar_CMAP_AMP | 1 years | The amplitude of the ulnar CMAP on stimulation at D4 |
Countries
Slovenia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 32 |
| 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. | 33 |
| 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. | 33 |
| 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. | 32 |
| Total | 130 |
Baseline characteristics
| Characteristic | UNE by CTE_surgery | UNE by CTE_conservative Treatment | UNE at RCC_surgery | UNE at RCC_conservative Treatment | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 8 Participants | 5 Participants | 6 Participants | 24 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants | 25 Participants | 28 Participants | 26 Participants | 106 Participants |
| Age, Continuous | 63 years | 69 years | 58 years | 60 years | 63 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 32 Participants | 33 Participants | 33 Participants | 32 Participants | 130 Participants |
| Region of Enrollment Slovenia | 32 Participants | 33 Participants | 33 Participants | 32 Participants | 130 Participants |
| Sex: Female, Male Female | 7 Participants | 7 Participants | 12 Participants | 8 Participants | 34 Participants |
| Sex: Female, Male Male | 25 Participants | 26 Participants | 21 Participants | 24 Participants | 96 Participants |
| Standard questionnaire for assessment of UNE severity (UNEQ) | 2.0 units on a scale | 2.0 units on a scale | 1.9 units on a scale | 1.9 units on a scale | 1.9 units on a scale |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 33 | 0 / 33 | 0 / 32 |
| other Total, other adverse events | 0 / 32 | 0 / 33 | 0 / 33 | 0 / 32 |
| serious Total, serious adverse events | 0 / 32 | 0 / 33 | 0 / 33 | 0 / 32 |
Outcome results
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.
Time frame: 1 year
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| UNE by CTE_surgery | UNEQ Score | Baseline | 2 score on a scale |
| UNE by CTE_surgery | UNEQ Score | 12 monts | 1.7 score on a scale |
| UNE by CTE_conservative Treatment | UNEQ Score | 12 monts | 2 score on a scale |
| UNE by CTE_conservative Treatment | UNEQ Score | Baseline | 2 score on a scale |
| UNE at RCC_surgery | UNEQ Score | Baseline | 1.9 score on a scale |
| UNE at RCC_surgery | UNEQ Score | 12 monts | 1.4 score on a scale |
| UNE at RCC_conservative Treatment | UNEQ Score | Baseline | 1.9 score on a scale |
| UNE at RCC_conservative Treatment | UNEQ Score | 12 monts | 1.6 score on a scale |
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.
Time frame: 1 years
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
Time frame: 1 year
Secondary
Muscles Strength
The percentage of patients with increased ADM/FDI muscle MRC grade
Time frame: 1 years
Secondary
Muscle Wasting
The percentage of patients with reduction in ulnar-innervated hand muscle atrophy
Time frame: 1 years
Secondary
Ulnar_CMAP_AMP
The amplitude of the ulnar CMAP on stimulation at D4
Time frame: 1 years
Secondary
Ulnar_MNCV
The percentage of patients with \>30% increase in MNCVmin
Time frame: 1 years
Secondary
Ulnar Nerve CSAmax
ulnar nerve CSAmax in the elbow segment
Time frame: 1 year
Secondary
Ulnar Nerve CSAmin
Ulnar nerve CSAmin in the elbow segment
Time frame: 1 year
Secondary
Ulnar_SNAP_AMP
The amplitude of the ulnar SNAP from the 5th finger
Time frame: 1 year