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    요천추 신경근 병증에 대한 침도요법의 임상시험 기관별 유효성, 안전성 비교 = Comparison of Effectiveness and Safety of Acupotomy for Lumbosacral Radiculopathy among Clinical Trial Centers

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    https://www.riss.kr/link?id=T17166969

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    다국어 초록 (Multilingual Abstract) kakao i 다국어 번역

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    한국어
    Background
    Lumbosacral radiculopathy is mainly caused by compression or stimulation of the nerve root, and causes various symptoms. Acupotomy is one of the most versatile treatment modalities for low back pain and lower extremity pain seen in lumbosacral radiculopathy. This study compared the effectiveness and safety of acupotomy at different research centers.

    Methods
    The study was designed to determine the consistency of acupotomy's effectiveness. There were 10 participants in Group A, and 5 each in Group B and Group C. All subjects receive acupotomy interventions twice a week for three weeks. Effectiveness will be assessed by Oswestry Disability Index(ODI), Numeral Rating Scale(NRS), Short Form-McGill Pain Questionnaire(SF-MPQ), and EuroQol 5-Dimension 5-Level(EQ-5D-5L) at baseline, after 3rd treatment, after 6th treatment, and at a follow-up period of 4 weeks after the end of treatment. Safety will be assessed at each visit.

    Results
    The mean difference in ODI, NRS, SF-MPQ and EQ-5D-5L showed therapeutic effects in all three groups, but Group A and Group B showed statistically significant therapeutic effects until the follow-up period. Group A showed statistically significant effects in the mean difference over time. The post hoc test confirmed the statistical significance between the groups at follow-up. Group A showed a significant effect compared to Group C on the ODI(p<0.05), and Group B showed a significant effect compared to Group C on the NRS for low back pain(p<0.05). There was no serious adverse events experienced by patients in this study.

    Conclusion
    For the most part, there were no statistically significant differences in the effectiveness of acupotomy among the three organizations, but there were differences in some assessment items. We hope that this study can be used as a reference for standardization in future multi-center clinical studies.
    번역하기

    Background Lumbosacral radiculopathy is mainly caused by compression or stimulation of the nerve root, and causes various symptoms. Acupotomy is one of the most versatile treatment modalities for low back pain and lower extremity pain seen in lumbo...

    Background
    Lumbosacral radiculopathy is mainly caused by compression or stimulation of the nerve root, and causes various symptoms. Acupotomy is one of the most versatile treatment modalities for low back pain and lower extremity pain seen in lumbosacral radiculopathy. This study compared the effectiveness and safety of acupotomy at different research centers.

    Methods
    The study was designed to determine the consistency of acupotomy's effectiveness. There were 10 participants in Group A, and 5 each in Group B and Group C. All subjects receive acupotomy interventions twice a week for three weeks. Effectiveness will be assessed by Oswestry Disability Index(ODI), Numeral Rating Scale(NRS), Short Form-McGill Pain Questionnaire(SF-MPQ), and EuroQol 5-Dimension 5-Level(EQ-5D-5L) at baseline, after 3rd treatment, after 6th treatment, and at a follow-up period of 4 weeks after the end of treatment. Safety will be assessed at each visit.

    Results
    The mean difference in ODI, NRS, SF-MPQ and EQ-5D-5L showed therapeutic effects in all three groups, but Group A and Group B showed statistically significant therapeutic effects until the follow-up period. Group A showed statistically significant effects in the mean difference over time. The post hoc test confirmed the statistical significance between the groups at follow-up. Group A showed a significant effect compared to Group C on the ODI(p<0.05), and Group B showed a significant effect compared to Group C on the NRS for low back pain(p<0.05). There was no serious adverse events experienced by patients in this study.

    Conclusion
    For the most part, there were no statistically significant differences in the effectiveness of acupotomy among the three organizations, but there were differences in some assessment items. We hope that this study can be used as a reference for standardization in future multi-center clinical studies.

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    목차 (Table of Contents)

    • 목 차 ⅰ
    • 표 목 차 ⅲ
    • 그림목차 ⅳ
    • Ⅰ. 서 론 01
    • Ⅱ. 연구대상 및 연구방법 03
    • 목 차 ⅰ
    • 표 목 차 ⅲ
    • 그림목차 ⅳ
    • Ⅰ. 서 론 01
    • Ⅱ. 연구대상 및 연구방법 03
    • 1. 연구 설계 03
    • 2. 연구 대상 04
    • 1) 선정 기준 04
    • 2) 제외 기준 05
    • 3. 연구 방법 06
    • 1) 연구 계획 및 일정 06
    • 2) 중재 방법 08
    • (1) 심부협척혈 침도요법 08
    • 3) 평가 방법 11
    • (1) 기능장애 평가 12
    • (2) 통증 평가 13
    • (3) 삶의 질 평가 14
    • (4) 이상 반응 확인 15
    • 4) 통계 분석 16
    • Ⅲ. 연구 결과 17
    • 1. 대상자 모집 17
    • 2. 인구학적 특성 18
    • 3. 유효성 평가변수 분석 20
    • 1) ODI 20
    • 2) NRS 23
    • (1) 요천추부 23
    • (2) 하지부 26
    • 3) SF-MPQ 29
    • (1) TPRI 29
    • (2) VAS 32
    • (3) PPI 35
    • 4) EQ-5D-5L 38
    • 4. 안전성 평가 41
    • 1) 신체검사, 활력징후 평가 41
    • 2) 이상 반응 평가 41
    • Ⅳ. 고 찰 42
    • Ⅴ. 결 론 47
    • 참 고 문 헌 48
    • 영 문 초 록 53
    • 부 록 55
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