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

NCT02672631 | Unknown

• 1 other identifier: ENMG and MRI on Median Nerve
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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".

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Electroneuromyography

  conventional evaluation of nerve healing - That evaluate axonal transfer speed etc

  2 months

• Physical Examination

  conventional evaluation of nerve healing. That Evaluate sensitivity, motor functions and paresthesia

  2 months

Secondary Outcomes (1)

• Diffusion Tensor Imaging Methods

  2 months

Study Arms (2)

Median Nerve injury hand

Participants will be randomly called; and that 10 participants which had unilateral median nerve transection totally and repaired primely in our clinic at 2014. In the sample, correlations between physical examination (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), ENMG with the DTI results will be assessed.

Other: physical examination; Other: DTI; Other: ENMG

Healthy Hand

Control group will be taken from patients other hand which had not injured before. And we will compare with first group's results.

Other: physical examination; Other: DTI; Other: ENMG

Interventions

physical examination OTHER

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)

Healthy Hand; Median Nerve injury hand

DTI OTHER

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

Also known as: Diffusion Tensor Imaging

Healthy Hand; Median Nerve injury hand

ENMG OTHER

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

Also known as: Electroneuromyography

Healthy Hand; Median Nerve injury hand

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• years old
• Total and isolated median nerve transection

You may not qualify if:

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

Sponsors & Collaborators

• TC Erciyes University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Erciyes University Faculty of Medicine

Melikgazi, Kayseri, 38050, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Restraint, Physical; Diffusion Tensor Imaging

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diffusion Magnetic Resonance Imaging; Magnetic Resonance Imaging; Tomography; Diagnostic Techniques, Neurological

Study Officials

• İbrahim Karaman, ass.doc.dr

  TC Erciyes University

  STUDY DIRECTOR

Central Study Contacts

Ali Eray Günay

CONTACT

+905556493401; alieraygunay@hotmail.com

İbrahim Karaman, ass.doc.dr

CONTACT

+903522076666; drikaraman@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor doctor

Study Record Dates

• First Submitted: January 19, 2016
• First Posted: February 3, 2016
• Study Start: January 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: February 3, 2016

Record last verified: 2016-01

Locations

TU (1)