Comparison of Effect of Anterior Subcutaneous and Submuscular Transposition on Cubital Tunnel Syndrome

Phase 2

Completed

• Conditions: Cubital Tunnel Syndrome
• Interventions: Procedure: Anterior submuscular transposition; Procedure: anterior subcutaneous transposition

• Registration Number: NCT01109901
• Lead Sponsor: Isfahan University of Medical Sciences

Brief Summary

The purpose of this study is to determine which surgical method is better for cubital tunnel syndrome in outcomes.

Detailed Description

Compression of the ulnar nerve at the cubital tunnel is the most common cause of numbness on the ulnar side of the hand. We aimed to compare patient outcomes included pain, sensation, muscle strength and muscle atrophy in two methods of surgery contain Anterior Sub Cutaneous Transposition (ASCT) and Anterior Sub Muscular Transposition (ASMT) of the ulnar nerve in Cubital tunnel syndrome.

Study Timeline

• Status Verified: 2008-10
• Study Start: 2008-10
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Study First Submitted: 2010-04-19
• Study First Submitted QC: 2010-04-22
• Last Update Submitted: 2010-04-22
• Study First Posted: 2010-04-23
• Last Update Posted: 2010-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• patients with confirmed 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
anterior submuscular transposition	Anterior submuscular transposition	it is kind of surgical method
Anterior subcutaneous transposition	anterior subcutaneous transposition	it is kind of surgical method

Primary Outcome Measures

Name	Time	Method
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)

Secondary 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.
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)
Muscle atrophy	at 6 months post-operatively	Muscle atrophy was scored with one orthopedic surgeon as follows: 0, sever; 1, moderate; 2, none

Trial Locations

Locations (1)

Al-zahra university hospital; 🇮🇷 Isfahan, Iran, Islamic Republic of