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

Not Applicable

• Conditions: Cubital Tunnel Syndrome
• Interventions: Procedure: simple decompression; Procedure: anterior subcutaneous transposition; Procedure: anterior intramuscular transposition

• Registration Number: NCT01893164
• Lead Sponsor: Jilin University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2013-07
• Study Start: 2013-07
• Study First Submitted: 2013-07-02
• Study First Submitted QC: 2013-07-05
• Last Update Submitted: 2013-07-05
• Study First Posted: 2013-07-08
• Last Update Posted: 2013-07-08
• Primary Completion: 2014-07
• Study Completion: 2014-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 144

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
moderate cubital tunnel syndrome	simple decompression	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.
moderate cubital tunnel syndrome	anterior subcutaneous transposition	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.
moderate cubital tunnel syndrome	anterior intramuscular transposition	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.
severe cubital tunnel syndrome	simple decompression	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.
severe cubital tunnel syndrome	anterior subcutaneous transposition	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.
severe cubital tunnel syndrome	anterior intramuscular transposition	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.

Primary Outcome Measures

Name	Time	Method
sensation	at 6 months post-operatively	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.

Secondary Outcome Measures

Name	Time	Method
Muscle strength	at 6 months post-operatively	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)
pain	at 6 months post-operatively	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)
electromyography	at 6 months post-operatively	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.

Trial Locations

Locations (1)

Hand Surgery Department of China-Japan Union Hospital; 🇨🇳 Changchun, Jilin, China