| Summary: | 碩士 === 逢甲大學 === 生醫資訊暨生醫工程碩士學程 === 103 === In clinical setting, nerve conduction velocity (NCV) measures and electromyography (EMG) have been accepted to be the gold standard in the evaluation of nerve and muscle function before pain management. Apart from the conventional NCV and EMG measures, laser Doppler flowmetry (LDF) provides a new perspective on pain from the microcirculatory point of view. Recent researches have revealed that the interaction between the blood vessels and nociceptors is important to the activation of muscle nociceptors, and LDF is expected to play an important role in the assessment of chronic pain. However, most of these studies were only conducted by visual interpretation on the LDF flux signal. It is not easy to obtain the consensus without the quantification indices for scientific studies. As an alternative tool, there still lacks common quantification measures for the LDF flux signal for the assessment of pain. To solve the quantification issue thus become the prerequisite for any further studies in this field.
The objective of this project is to develop the LDF device that can be utilized for the quantification of chronic shoulder and neck pain in a non-invasive way for the office workers. Due to the miscellaneous terms in pain, this project will be dedicated to the technology development for the occurrence assessment of pain, but not the level of pain, for the office workers in a two-year duration. In the first year, the clinical trials will be conducted by the commercial LDF equipment. Two kinds of experiment will be performed to determine what quantification indices are sensitive to the evaluation of chronic shoulder and neck pain. The preliminary plan for the quantization of flux signal is the analysis by wavelet transform in the frequency range of 0.0095 ~ 1.6 Hz and by the computation of perfusion index (PI). The development of LDF and photoplethysmography (PPG) device, which includes the system design and the graphical user interface (GUI) application program on tablet PC platform, will finished in the first year. The verification and validation process will be performed for the developed LDF device during the development period to assure the substantial equivalence to the commercial LDF equipment. In this issue, the data will be collected and compared by both the commercial LDF system and the developed device for all of the subjects in the clinical trials under well-controlled situations. It is expected such technology can improve the quality of pain treatments by the medical staff in the future.
This LDF device will be developed under the process regulated by ISO 13485 (quality management for the medical devices), ISO 14971 (application of risk analysis to medical analysis) and IEC 62304 (software life cycle processes of medical device). The design will also satisfy the requirements regulated by IEC 60601-1 (for electrical safety of medical device) and IEC 60825-1 (safety of laser products).
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