A Phase 2 interventional study of anterior subcutaneous transposition and Anterior submuscular transposition in Cubital Tunnel Syndrome, sponsored by Isfahan University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Per ClinicalTrials.gov, last updated 2010-04-23.
Sponsored by Isfahan University of Medical Sciences · Phase 2, Interventional, and Treatment
The purpose of this study is to determine which surgical method is better for cubital tunnel syndrome in outcomes.
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.
35 studies on the registry are indexed under Cubital Tunnel Syndrome; 7 are open to participants now.
This study's enrollment of 48 is below the median of 63 across 24 interventional studies indexed under Cubital Tunnel Syndrome.
Browse Cubital Tunnel Syndrome studies →Isfahan University of Medical Sciences is the lead sponsor of 145 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
it is kind of surgical method
Procedure: Anterior submuscular transposition
it is kind of surgical method
Procedure: anterior subcutaneous transposition
transposition of ulnar nerve into subcutaneous bed
Also known as: ASCT
transposition of ulnar nerve into muscular tissue
Also known as: ASMT
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)
Time frame: at 6 months post-operatively
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.
Time frame: at 6 months post-operatively
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)
Time frame: at 6 months post-operatively
Muscle atrophy
Muscle atrophy was scored with one orthopedic surgeon as follows: 0, sever; 1, moderate; 2, none
Time frame: at 6 months post-operatively
This study is completed, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.
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Isfahan University of Medical Sciences