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Completed

NCT Number: NCT01109901

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

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

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Al-zahra university hospital

Isfahan, 70007, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

anterior subcutaneous transposition

Procedure

transposition of ulnar nerve into subcutaneous bed

Other names: ASCT

Anterior submuscular transposition

Procedure

transposition of ulnar nerve into muscular tissue

Other names: ASMT

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Isfahan University of Medical Sciences

Other

Registry information

Official study title

Study of Surgical Methods for Cubital Tunnel Syndrome

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 23, 2010
Registry last updated
Apr 23, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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