Back to resultsComparison of Different Surgical Treatments for Different Scales of Cubital Tunnel Syndrome
Primary Purpose
Cubital Tunnel Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
simple decompression
anterior subcutaneous transposition
anterior intramuscular transposition
Sponsored by
About this trial
This is an interventional treatment trial for Cubital Tunnel Syndrome focused on measuring cubital tunnel syndrome, simple decompression, anterior subcutaneous transposition of ulnar nerve, anterior intramuscular transposition of ulnar nerve, severity scale
Eligibility Criteria
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.
Sites / Locations
- Hand Surgery Department of China-Japan Union HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
moderate cubital tunnel syndrome
severe cubital tunnel syndrome
Arm Description
Sensory,Intermittent paresthesias; vibratory perception normal or decreasedMotor,Measurable weakness in pinch or grip strengthTests,Elbow flexion test or Tinel's sign is positive; finger crossing may be abnormal.Treated by simple decompression,anterior subcutaneous transposition and anterior intramuscular transposition of the ulnar nerve.
Sensory,Persistent paresthesias; vibratory perception decreased; abnormal two-point discrimination(static >6 mm, moving >4 mm)Motor,Measurable weakness in pinch and grip plus muscle atrophyTests,Positive elbow flexion test or positive Tinel's sign may be present; finger crossing usually abnormal.Treated by simple decompression,anterior subcutaneous transposition and anterior intramuscular transposition of the ulnar nerve.
Outcomes
Primary 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.
Secondary Outcome Measures
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)
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)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01893164
Brief Title
Comparison of Different Surgical Treatments for Different Scales of Cubital Tunnel Syndrome
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
July 2014 (Anticipated)
Study Completion Date
October 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jilin University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine which is the best surgery to treat different severity scales of cubital tunnel syndrome.
Detailed 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.
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 syndrome, simple decompression, anterior subcutaneous transposition of ulnar nerve, anterior intramuscular transposition of ulnar nerve, severity scale
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
144 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
moderate cubital tunnel syndrome
Arm Type
Experimental
Arm Description
Sensory,Intermittent paresthesias; vibratory perception normal or decreasedMotor,Measurable weakness in pinch or grip strengthTests,Elbow flexion test or Tinel's sign is positive; finger crossing may be abnormal.Treated by simple decompression,anterior subcutaneous transposition and anterior intramuscular transposition of the ulnar nerve.
Arm Title
severe cubital tunnel syndrome
Arm Type
Experimental
Arm Description
Sensory,Persistent paresthesias; vibratory perception decreased; abnormal two-point discrimination(static >6 mm, moving >4 mm)Motor,Measurable weakness in pinch and grip plus muscle atrophyTests,Positive elbow flexion test or positive Tinel's sign may be present; finger crossing usually abnormal.Treated by simple decompression,anterior subcutaneous transposition and anterior intramuscular transposition of the ulnar nerve.
Intervention Type
Procedure
Intervention Name(s)
simple decompression
Other Intervention Name(s)
SDP
Intervention Description
decompression of the ulnar nerve
Intervention Type
Procedure
Intervention Name(s)
anterior subcutaneous transposition
Other Intervention Name(s)
ASCT
Intervention Description
transposition of the ulnar nerve into subcutaneous bed
Intervention Type
Procedure
Intervention Name(s)
anterior intramuscular transposition
Other Intervention Name(s)
AIMT
Intervention Description
transposition of the ulnar nerve into muscular tissue
Primary 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
Secondary Outcome Measure Information:
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
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
Title
electromyography
Description
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.
Time Frame
at 6 months post-operatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rui Li, chief doctor
Organizational Affiliation
Hand Sugery Department of the China-Japan Union Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Hand Surgery Department of China-Japan Union Hospital
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rui Li, chief doctor
Phone
13304321102
Email
447567095@qq.com
12. IPD Sharing Statement
Learn more about this trial
Comparison of Different Surgical Treatments for Different Scales of Cubital Tunnel Syndrome
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