Comparison of Different Surgical Treatments for Different Scales of Cubital Tunnel Syndrome

Study Overview
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Brief Summary
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The purpose of this study is to determine which is the best surgery to treat different severity scales of cubital tunnel syndrome.

Detailed Description
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The purpose of this study is to determine which one of the simple decompression,anterior subcutaneous and intramuscular transposition of the ulnar nerve has the best outcomes for moderate and severe cubital tunnel syndrome.

Official Title
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Comparison of Simple Decompression Versus Anterior Subcutaneous and Intramuscular Transposition of the Ulnar Nerve for Moderate and Severe Cubital Tunnel Syndrome ：A Randomized Double-blind Control Trial

Conditions
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Cubital Tunnel Syndrome

Intervention / Treatment
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* Procedure: simple decompression
* Procedure: anterior subcutaneous transposition
* Procedure: anterior intramuscular transposition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with confirmed cubital tunnel syndrome moderate and severe cubital tunnel syndrome. Exclusion Criteria: Significant cervical spine and shoulder disease deformity or distortion of the cubital tunnel due to previous trauma to elbow recurrent cubital tunnel syndrome after previous surgery mild cubital tunnel syndrome.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: moderate cubital tunnel syndrome<br>Sensory,Intermittent paresthesias; vibratory perception normal or decreasedMotor,Measurable weakness in pinch or grip strengthTests,Elbow flexion test or Tinel's sign is positive; finger crossing may be abnormal.Treated by simple decompression,anterior subcutaneous transposition and anterior intramuscular transposition of the ulnar nerve. | Procedure: simple decompression<br>* decompression of the ulnar nerve<br>* Other names: SDP;Procedure: anterior subcutaneous transposition<br>* transposition of the ulnar nerve into subcutaneous bed<br>* Other names: ASCT;Procedure: anterior intramuscular transposition<br>* transposition of the ulnar nerve into muscular tissue<br>* Other names: AIMT;|
| Experimental: severe cubital tunnel syndrome<br>Sensory,Persistent paresthesias; vibratory perception decreased; abnormal two-point discrimination(static >6 mm, moving >4 mm)Motor,Measurable weakness in pinch and grip plus muscle atrophyTests,Positive elbow flexion test or positive Tinel's sign may be present; finger crossing usually abnormal.Treated by simple decompression,anterior subcutaneous transposition and anterior intramuscular transposition of the ulnar nerve. | Procedure: simple decompression<br>* decompression of the ulnar nerve<br>* Other names: SDP;Procedure: anterior subcutaneous transposition<br>* transposition of the ulnar nerve into subcutaneous bed<br>* Other names: ASCT;Procedure: anterior intramuscular transposition<br>* transposition of the ulnar nerve into muscular tissue<br>* Other names: AIMT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensation | Sensory disturbance were tested with Semmes-Weinstein filaments and sensory deficits were categorized according to the Yale sensory scale. According to standard scoring system that designed, the severity of sensation and function of the ulnar nerve was scored as follows: ---- 0, Abscent sensation; 1, Decrease or abnormal sensation; 2, Intact sensation. | at 6 months post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strength | Muscle strength was evaluated with the grading system from the Medical Research Council which is based upon a scale of zero to five: 0, No muscle contraction; 1,Flicker or trace of muscle contraction; 2,Limb or joint movement possible only with gravity eliminated; 3,Limb or joint movement against gravity only; 4,Power decreased but limb or joint movement possible against resistance; 5,Normal power against resistance. Then results were scored as follows: ---- 0,Poor (0-1); 1,Moderate (2-3); 2,Good (4-5) | at 6 months post-operatively | 
| pain | Visual Analogue Scale (VAS) with scores of zero to ten (0 for no pain and 10 intolerable pain) then scored as follows: ---- 0, Sever (8-10); 1, Slight (4-7); 2, none (0-3) | at 6 months post-operatively | 
| electromyography | Compare the result at 6 months post-operatively with the result before operation.To see if there is an improvement in the function of the ulnar nerve.0,no improvement;1,improvement. | at 6 months post-operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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severity scale, cubital tunnel syndrome, simple decompression, anterior subcutaneous transposition of ulnar nerve, anterior intramuscular transposition of ulnar nerve