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

April 22, 2010 updated by: Isfahan University of Medical Sciences

Study of Surgical Methods for Cubital Tunnel Syndrome

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: anterior submuscular transposition
it is kind of surgical method
Procedure: Anterior submuscular transposition
transposition of ulnar nerve into muscular tissue
Other Names:
  • ASMT
OTHER: Anterior subcutaneous transposition
it is kind of surgical method
Procedure: anterior subcutaneous transposition
transposition of ulnar nerve into subcutaneous bed
Other Names:
  • ASCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: 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)
at 6 months post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sensation
Time Frame: 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.
at 6 months post-operatively
Muscle strength
Time Frame: 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)
at 6 months post-operatively
Muscle atrophy
Time Frame: at 6 months post-operatively
Muscle atrophy was scored with one orthopedic surgeon as follows: 0, sever; 1, moderate; 2, none
at 6 months post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Isfahan University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (ACTUAL)

March 1, 2009

Study Completion (ACTUAL)

March 1, 2009

Study Registration Dates

First Submitted

April 19, 2010

First Submitted That Met QC Criteria

April 22, 2010

First Posted (ESTIMATE)

April 23, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

April 23, 2010

Last Update Submitted That Met QC Criteria

April 22, 2010

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASD-1213

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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