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

Study of Surgical Methods for Cubital Tunnel Syndrome

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01109901
Enrollment
48
Registered
2010-04-23
Start date
2008-10-31
Completion date
2009-03-31
Last updated
2010-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cubital Tunnel Syndrome

Keywords

Cubital tunnel,subcutaneous transposition,submuscular

Brief summary

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

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.

Interventions

transposition of ulnar nerve into subcutaneous bed

PROCEDUREAnterior submuscular transposition

transposition of ulnar nerve into muscular tissue

Sponsors

Isfahan University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Painat 6 months post-operativelyVisual 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

MeasureTime frameDescription
Muscle atrophyat 6 months post-operativelyMuscle atrophy was scored with one orthopedic surgeon as follows: 0, sever; 1, moderate; 2, none
sensationat 6 months post-operativelySensory 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 strengthat 6 months post-operativelyMuscle 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)

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026