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Comparison of Different Surgical Treatments for Different Scales of Cubital Tunnel Syndrome

Comparison of Simple Decompression Versus Anterior Subcutaneous and Intramuscular Transposition of the Ulnar Nerve for Moderate and Severe Cubital Tunnel Syndrome :A Randomized Double-blind Control Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01893164
Enrollment
144
Registered
2013-07-08
Start date
2013-07-31
Completion date
2014-10-31
Last updated
2013-07-08

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 syndrome, simple decompression, anterior subcutaneous transposition of ulnar nerve, anterior intramuscular transposition of ulnar nerve, severity scale

Brief summary

The purpose of this study is to determine which is the best surgery to treat different severity scales of cubital tunnel syndrome.

Detailed description

The purpose of this study is to determine which one of the simple decompression,anterior subcutaneous and intramuscular transposition of the ulnar nerve has the best outcomes for moderate and severe cubital tunnel syndrome.

Interventions

transposition of the ulnar nerve into muscular tissue

decompression of the ulnar nerve

transposition of the ulnar nerve into subcutaneous bed

Sponsors

Jilin University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* patients with confirmed cubital tunnel syndrome * moderate and severe 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 * mild cubital tunnel syndrome.

Design outcomes

Primary

MeasureTime frameDescription
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.

Secondary

MeasureTime frameDescription
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)
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)
electromyographyat 6 months post-operativelyCompare the result at 6 months post-operatively with the result before operation.To see if there is an improvement in the function of the ulnar nerve.0,no improvement;1,improvement.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026