Trial record 1 of 6 for:    "Cubital Tunnel Syndrome"
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Comparison of Different Surgical Treatments for Different Scales of Cubital Tunnel Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Jilin University
Sponsor:
Information provided by (Responsible Party):
Rui Li, Jilin University
ClinicalTrials.gov Identifier:
NCT01893164
First received: July 2, 2013
Last updated: July 5, 2013
Last verified: July 2013
  Purpose

The purpose of this study is to determine which is the best surgery to treat different severity scales of cubital tunnel syndrome.


Condition Intervention
Cubital Tunnel Syndrome
Procedure: simple decompression
Procedure: anterior subcutaneous transposition
Procedure: anterior intramuscular transposition

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Jilin University:

Primary Outcome Measures:
  • sensation [ Time Frame: at 6 months post-operatively ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: at 6 months post-operatively ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 144
Study Start Date: July 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01893164

Locations
China, Jilin
Hand Surgery Department of China-Japan Union Hospital Recruiting
Changchun, Jilin, China, 130000
Contact: Rui Li, chief doctor    13304321102    447567095@qq.com   
Sponsors and Collaborators
Jilin University
Investigators
Study Chair: Rui Li, chief doctor Hand Sugery Department of the China-Japan Union Hospital
  More Information

No publications provided

Responsible Party: Rui Li, chief doctor and PhD supervisor, Jilin University
ClinicalTrials.gov Identifier: NCT01893164     History of Changes
Other Study ID Numbers: JilinU-218-RLi
Study First Received: July 2, 2013
Last Updated: July 5, 2013
Health Authority: China: Ethics Committee

Keywords provided by Jilin University:
cubital tunnel syndrome
simple decompression
anterior subcutaneous transposition of ulnar nerve
anterior intramuscular transposition of ulnar nerve
severity scale

Additional relevant MeSH terms:
Cubital Tunnel Syndrome
Ulnar Neuropathies
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Ulnar Nerve Compression Syndromes
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries

ClinicalTrials.gov processed this record on August 21, 2014