Comparison of Effect of Anterior Subcutaneous and Submuscular Transposition on Cubital Tunnel Syndrome
Primary Purpose
Cubital Tunnel Syndrome
Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
anterior subcutaneous transposition
Anterior submuscular transposition
Sponsored by
About this trial
This is an interventional treatment trial for Cubital Tunnel Syndrome focused on measuring Cubital tunnel,subcutaneous transposition,submuscular
Eligibility Criteria
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.
Sites / Locations
- Al-zahra university hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
anterior submuscular transposition
Anterior subcutaneous transposition
Arm Description
it is kind of surgical method
it is kind of surgical method
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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.
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)
Muscle atrophy
Muscle atrophy was scored with one orthopedic surgeon as follows: 0, sever; 1, moderate; 2, none
Full Information
NCT ID
NCT01109901
First Posted
April 19, 2010
Last Updated
April 22, 2010
Sponsor
Isfahan University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01109901
Brief Title
Comparison of Effect of Anterior Subcutaneous and Submuscular Transposition on Cubital Tunnel Syndrome
Official Title
Study of Surgical Methods for Cubital Tunnel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Isfahan University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cubital Tunnel Syndrome
Keywords
Cubital tunnel,subcutaneous transposition,submuscular
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
anterior submuscular transposition
Arm Type
Other
Arm Description
it is kind of surgical method
Arm Title
Anterior subcutaneous transposition
Arm Type
Other
Arm Description
it is kind of surgical method
Intervention Type
Procedure
Intervention Name(s)
anterior subcutaneous transposition
Other Intervention Name(s)
ASCT
Intervention Description
transposition of ulnar nerve into subcutaneous bed
Intervention Type
Procedure
Intervention Name(s)
Anterior submuscular transposition
Other Intervention Name(s)
ASMT
Intervention Description
transposition of ulnar nerve into muscular tissue
Primary Outcome Measure Information:
Title
Pain
Description
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)
Time Frame
at 6 months post-operatively
Secondary Outcome Measure Information:
Title
sensation
Description
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.
Time Frame
at 6 months post-operatively
Title
Muscle strength
Description
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)
Time Frame
at 6 months post-operatively
Title
Muscle atrophy
Description
Muscle atrophy was scored with one orthopedic surgeon as follows: 0, sever; 1, moderate; 2, none
Time Frame
at 6 months post-operatively
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hamidreza Shemshaki, MD
Organizational Affiliation
MD,research comittee
Official's Role
Study Chair
Facility Information:
Facility Name
Al-zahra university hospital
City
Isfahan
ZIP/Postal Code
70007
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Links:
URL
http://www.mui.ac.ir
Description
Isfahan university of medical science
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Comparison of Effect of Anterior Subcutaneous and Submuscular Transposition on Cubital Tunnel Syndrome
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