ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01109901
Recruitment Status : Completed
First Posted : April 23, 2010
Last Update Posted : April 23, 2010
Sponsor:
Information provided by:
Isfahan University of Medical Sciences

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

Condition or disease Intervention/treatment Phase
Cubital Tunnel Syndrome Procedure: anterior subcutaneous transposition Procedure: Anterior submuscular transposition Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Surgical Methods for Cubital Tunnel Syndrome
Study Start Date : October 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.

  2. 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)

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



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
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
First Posted: April 23, 2010    Key Record Dates
Last Update Posted: April 23, 2010
Last Verified: October 2008

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

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