Trials / Unknown
UnknownNCT02672631
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 20 (estimated)
- Sponsor
- TC Erciyes University · Academic / Other
- Sex
- All
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | physical 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) |
| OTHER | DTI | 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 |
| OTHER | ENMG | 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 |
Timeline
- Start date
- 2016-01-01
- Primary completion
- 2016-11-01
- Completion
- 2016-11-01
- First posted
- 2016-02-03
- Last updated
- 2016-02-03
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT02672631. Inclusion in this directory is not an endorsement.