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Comparison of Different Surgical Treatments for Different Scales of Cubital Tunnel Syndrome

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ClinicalTrials.gov Identifier: NCT01893164
Recruitment Status : Unknown
Verified July 2013 by Rui Li, Jilin University.
Recruitment status was:  Recruiting
First Posted : July 8, 2013
Last Update Posted : July 8, 2013
Sponsor:
Information provided by (Responsible Party):
Rui Li, Jilin University

Tracking Information
First Submitted Date  ICMJE July 2, 2013
First Posted Date  ICMJE July 8, 2013
Last Update Posted Date July 8, 2013
Study Start Date  ICMJE July 2013
Estimated Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2013)
  • 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)
  • 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)
  • electromyography [ Time Frame: at 6 months post-operatively ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Different Surgical Treatments for Different Scales of Cubital Tunnel Syndrome
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cubital Tunnel Syndrome
Intervention  ICMJE
  • Procedure: simple decompression
    decompression of the ulnar nerve
    Other Name: SDP
  • Procedure: anterior subcutaneous transposition
    transposition of the ulnar nerve into subcutaneous bed
    Other Name: ASCT
  • Procedure: anterior intramuscular transposition
    transposition of the ulnar nerve into muscular tissue
    Other Name: AIMT
Study Arms  ICMJE
  • Experimental: moderate cubital tunnel syndrome
    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.
    Interventions:
    • Procedure: simple decompression
    • Procedure: anterior subcutaneous transposition
    • Procedure: anterior intramuscular transposition
  • Experimental: severe cubital tunnel syndrome
    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.
    Interventions:
    • Procedure: simple decompression
    • Procedure: anterior subcutaneous transposition
    • Procedure: anterior intramuscular transposition
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 5, 2013)
144
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2014
Estimated Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01893164
Other Study ID Numbers  ICMJE JilinU-218-RLi
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rui Li, Jilin University
Study Sponsor  ICMJE Jilin University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Rui Li, chief doctor Hand Sugery Department of the China-Japan Union Hospital
PRS Account Jilin University
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP