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

Cubital Tunnel Syndrome Clinical Trial

Official title:

Study of Surgical Methods for Cubital Tunnel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01109901
• Other study ID #: ASD-1213
• Status: Completed
• Phase: Phase 2
• First received: April 19, 2010
• Last updated: April 22, 2010
• Start date: October 2008
• Est. completion date: March 2009

Study information

• Verified date: October 2008
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

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

Related Conditions & MeSH terms

• Cubital Tunnel Syndrome
• Syndrome

Intervention

Procedure:
• anterior subcutaneous transposition
transposition of ulnar nerve into subcutaneous bed
• Anterior submuscular transposition
transposition of ulnar nerve into muscular tissue

Locations

Country	Name	City	State
Iran, Islamic Republic of	Al-zahra university hospital	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Muscle atrophy	Muscle atrophy was scored with one orthopedic surgeon as follows: 0, sever; 1, moderate; 2, none	at 6 months post-operatively	Yes

External Links

•   Isfahan university of medical science