요천추 신경근병증에 대한 심부협척 침도 치료와 한의 복합 치료의 유효성 및 안전성 비교 임상연구

다국어 초록 (Multilingual Abstract)

Objective
The purpose of this study was to evaluate effectiveness and safety of acupotomy on lumbosacral radiculopathy compared to Integrative Korean Medicine treatment.

Methods
In this randomized, controlled, assessor-blinded, clinical trial, 50 patients with lumbosacral radiculopathy were involved randomly into acupotomy group and Integrative Korean Medicine treatment group in a 1:1 ratio. Each patient treated twice a week for 3 weeks. The primary outcome was the mean change in the Oswestry low back pain disability index(OLBPDI) score which compared visit 9 to visit 2. Secondary outcomes were OLBPDI score that compared visit 10 to visit 2 and numeral rating scale(NRS), McGill pain questionnaire(MPQ), Roland-Morris disability questionnaire(RMDQ), European quality of life 5 dimensions 5 levels (EQ-5D-5L) score that were conducted at visit 2, visit 9, visit 10. Safety was checked by patient reported outcomes-common terminology criteria for adverse event(PRO-CTCAE) and adverse events were recorded at every visit. Full analysis set(FAS), analysis of covariance(ANVOCA), mixed models for repeated measures(MMRM) were used for statistical analysis.

Results
The Acupotomy group and the Integrative Korean Medicine treatment group showed improvement in OLBPDI score which compared visit 9 to visit 2 and OLBPDI, MPQ, EQ-5D-5L score that compared visit 9, visit 10 to visit 2. But there was no significant difference between two groups. NRS and RMDQ score that compared visit 10 to visit 2 showed statistical efficiency between two groups. NRS score also showed improvement in both groups. But Integrative Korean Medicine treatment group was better than acupotomy group. At the severity survey in PRO-CTCAE, we could find out statistical efficiency that acupotomy group showed more improvement than Integrative Korean Medicine treatment group. No serious adverse events were founded.

Conclusion
The acupotomy and the Integrative Korean Medicine treatment showed clinical effect for improving the symptoms of lumbosacral radiculopathy. But there was no significant difference between two groups. There were no serious adverse events.

Key words: lumbosacral radiculopathy, acupotomy, Integrative Korean Medicine treatment, randomized controlled trial

목차 (Table of Contents)

• Ⅰ. 서 론 01
• Ⅱ. 연구 대상 및 연구 방법 02
• 1. 연구 설계 02
• 2. 연구 대상 03
• 1) 선정 기준 03
• 2) 제외 기준 04
• 3. 연구 방법 05
• 1) 연구 계획 및 일정 05
• 2) 중재 08
• (1) 심부협척 침도 치료군 08
• (2) 한의 복합 치료군 11
• (3) 구제 약물 12
• 3) 평가 방법 13
• (1) 1차 유효성 평가 13
• (2) 2차 유효성 평가 14
• ① 통증 및 기능 장애 14
• ② 삶의 질 15
• (3) 탐색적 유효성 평가 16
• (4) 안전성 평가 17
• 4) 통계 분석 18
• Ⅲ. 연구 결과 19
• 1. 대상자 모집 19
• 2. 인구학적 특성 20
• 3. 유효성 평가 21
• 1) 1차 유효성 평가변수 분석 21
• 2) 2차 유효성 평가변수 분석 22
• (1) OLBPDI 22
• (2) NRS 23
• (3) MPQ 25
• (4) RMDQ 28
• (5) EQ-5D-5L 29
• 3) 탐색적 유효성 평가변수 30
• (1) 추가적인 시술 및 수술 시행 여부 30
• (2) 치료 조기 종료율 평가 30
• (3) 구제 약물 사용 분석 30
• 4) 안전성 평가 31
• (1) PRO-CTCAE 31
• (2) 이상반응 및 중대한 이상반응 분석 33
• Ⅳ. 고 찰 34
• Ⅴ. 결 론 38
• 참 고 문 헌 40
• 영 문 초 록 43
• 부 록 45