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

Cubital Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01893164
• Other study ID #: JilinU-218-RLi
• Status: Recruiting
• Phase: N/A
• First received: July 2, 2013
• Last updated: July 5, 2013
• Start date: July 2013
• Est. completion date: October 2014

Study information

• Verified date: July 2013
• Source: Jilin University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: October 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cubital Tunnel Syndrome
• Syndrome

Intervention

Procedure:
• simple decompression
decompression of the ulnar nerve
• anterior subcutaneous transposition
transposition of the ulnar nerve into subcutaneous bed
• anterior intramuscular transposition
transposition of the ulnar nerve into muscular tissue

Locations

Country	Name	City	State
China	Hand Surgery Department of China-Japan Union Hospital	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Jilin University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes