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Evaluation of Complete Median Nerve Transection With Clinical, Electroneuromyographic and Diffusion Tensor Imaging

Evaluation of Primary Repaired Wrist Level Complete Median Nerve Transection With Clinical, Electroneuromyographic (ENMG) and Diffusion Tensor Imaging (DTI) Methods

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02672631
Enrollment
20
Registered
2016-02-03
Start date
2016-01-31
Completion date
2016-11-30
Last updated
2016-02-03

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

Conditions

Wound, Healed (Morphologic Abnormality), Injury of Median Nerve

Brief summary

The aim of this study is to determine whether clinical, sensory and motor development correlated with the values obtained from Electroneuromyography and DTI in postoperative follow up patients who underwent primary repair after the total median nerve injuries. Median nerve is one of three major nerves of hand and forearm and often injure with glass etc, in follow up of healing; clinical examination and ENMG are often used. Both of these methods are subjective, noninvasive and objective new method is required. In this context; differences between intact, recovering and not healed nerve tissue's diffusions have led to the hypothesis; The recovery of the repaired nerve tissue can be monitored by Diffusion Tensor Imaging method.

Detailed description

The aim of this study is to determine whether clinical, sensory and motor development correlated with the values obtained from Electroneuromyography and DTI in postoperative follow up patients who underwent primary repair after the total median nerve injuries. Median nerve is one of three major nerves of hand and forearm. It is below flexor tendon and retinaculum at the level of the wrist and often injured at this level and subtotally. The primary microsurgical suture technique under a microscope is the gold standard treatment. In follow up of healing; clinical examination and ENMG are often used. Both of these methods are subjective, although ENMG is more objective, however that is an invasive method, and need experienced neurologists. So, noninvasive and objective new method is required. In this context; differences between intact, recovering and not healed nerve tissue's diffusions have led to the hypothesis; The recovery of the repaired nerve tissue can be monitored by Diffusion Tensor Imaging method. There is no similar study in the literature. Ten patients who were operated for median nerve injuries in 2014 will be enrolled. In the sample, correlations between Tinnel Test, motor strength assessment (Medical Research Council (MRC) Scale), static two-point discrimination test (S2PD), Semmes-Weinstein (SW) monofilament test, the Disability of the Arm, Shoulder and Hand (DASH) test, EMG with the DTI results will be assessed. At the end of the study; it is expected that a significant correlation between conventional methods and DTI. If the results support the hypothesis; DTI may get to the literature as noninvasive and objective method in follow of nerve regeneration.

Interventions

OTHERENMG

Investigators will apply for evaluate median nerve healing countable results to all of groups. And they will evaluate motor nerve transmission speed, sensitive nerve transmission speed and united muscle action potential

OTHERphysical examination

Investigators will apply for evaluate clinical median nerve function to all of groups. (Adductor pollicis power (x/5), sense exam(normal/hipoestesia/anestesia) of hand, tinnel test(+/-), DASH score, DN4 neuropathic pain score)

OTHERDTI

Investigators will apply for evaluate median nerve healing countable results to all of groups (apparent diffusion coefficient for avarage diffusion (ADC) and fractional anisotropy diffusion orientation(FA) - FA :0 means diffusion is homogenic FA:1 means tissue has heterogenic diffusion

Sponsors

The Scientific and Technological Research Council of Turkey
CollaboratorOTHER
TC Erciyes University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* 18 - 40 years old * Total and isolated median nerve transection

Exclusion criteria

* Under 18 and over 40 years old * Partially transection of median nerve * Median nerve transection with radial or ulnar nerve injury

Design outcomes

Primary

MeasureTime frameDescription
Electroneuromyography2 monthsconventional evaluation of nerve healing - That evaluate axonal transfer speed etc
Physical Examination2 monthsconventional evaluation of nerve healing. That Evaluate sensitivity, motor functions and paresthesia

Secondary

MeasureTime frameDescription
Diffusion Tensor Imaging Methods2 monthsnew method for evaluation of nerve healing with tissues diffusion on magnetic resonants imaging

Countries

Turkey (Türkiye)

Contacts

Primary ContactAli Eray Günay
alieraygunay@hotmail.com+905556493401
Backup Contactİbrahim Karaman, ass.doc.dr
drikaraman@gmail.com+903522076666

Outcome results

None listed

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