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

This study has been completed.
Sponsor:
Information provided by:
Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01109901
First received: April 19, 2010
Last updated: April 22, 2010
Last verified: October 2008
  Purpose

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


Condition Intervention Phase
Cubital Tunnel Syndrome
Procedure: anterior subcutaneous transposition
Procedure: Anterior submuscular transposition
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Surgical Methods for Cubital Tunnel Syndrome

Resource links provided by NLM:


Further study details as provided by Isfahan University of Medical Sciences:

Primary Outcome Measures:
  • 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)


Secondary 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.

  • 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)

  • Muscle atrophy [ Time Frame: at 6 months post-operatively ] [ Designated as safety issue: Yes ]
    Muscle atrophy was scored with one orthopedic surgeon as follows: 0, sever; 1, moderate; 2, none


Enrollment: 48
Study Start Date: October 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
anterior submuscular transposition
it is kind of surgical method
Procedure: Anterior submuscular transposition
transposition of ulnar nerve into muscular tissue
Other Name: ASMT
Anterior subcutaneous transposition
it is kind of surgical method
Procedure: anterior subcutaneous transposition
transposition of ulnar nerve into subcutaneous bed
Other Name: ASCT

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  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: NCT01109901

Locations
Iran, Islamic Republic of
Al-zahra university hospital
Isfahan, Iran, Islamic Republic of, 70007
Sponsors and Collaborators
Isfahan University of Medical Sciences
Investigators
Study Chair: hamidreza Shemshaki, MD MD,research comittee
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Alireza Yousefy, Associate Professor of Medical Education, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01109901     History of Changes
Other Study ID Numbers: ASD-1213
Study First Received: April 19, 2010
Last Updated: April 22, 2010
Health Authority: Iran: Ministry of Health

Keywords provided by Isfahan University of Medical Sciences:
Cubital tunnel,subcutaneous transposition,submuscular

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

ClinicalTrials.gov processed this record on September 30, 2014