- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02593721
신경 동원 대 이부프로펜 약물 치료의 통각저하 효과
경추완 통증 환자에서 Ibuprofen 약물치료와 정중신경 신경가동술의 통각저하 효과
연구 개요
상세 설명
Median Nerve Neural Mobilization과 Ibuprofen은 둘 다 경추 상완 통증을 완화하지만 이것은 다른 메커니즘을 통해 발생하며 다른 부작용 시작과 함께 발생합니다. Median Nerve Neural Mobilization은 정중 신경과 상완 신경총의 기계적 자극을 통해 통증 완화를 달성하는 물리 치료 기술입니다. 신경 및 주변 신경 조직의 적절한 기계적 자극은 하강 신경계 통증 조절 메커니즘의 활성화를 포함하여 경추 통증을 감소시킬 수 있는 다양한 생리학적 반응을 유도합니다. 이해했다. 통증 완화를 일으키는 신경 조직 가동화로 인한 효과 중에는 신경내 부종 감소, 신경내 신경 압력의 변화, 전염증성 물질의 분산 및 신경 운동성 증가가 있습니다.
이부프로펜은 통증, 발열 및 염증을 조절하기 위해 전 세계적으로 사용되는 비스테로이드성 항염증제입니다. 이부프로펜을 경구 섭취하면 아라키돈산을 프로스타글란딘 H2(PGH2)로 전환시키는 COX 효소의 생화학적 억제로 인해 통각저하 효과가 나타납니다. PGH2는 다른 효소에 의해 여러 유형의 프로스타글란딘 및 트롬복산(통증 및 염증 매개체)으로 전환됩니다.
이부프로펜의 경구 섭취로 인한 부작용은 전신 작용과 관련이 있으며 일부 환자에게는 심각할 수 있습니다. 이 사실은 경구 이부프로펜이 경추 상완 통증을 앓고 있는 모든 유형의 환자에게 사용하기에 적합하지 않을 수 있음을 시사하는 반면, 정중 신경 신경 가동화는 알려진 부작용이 거의 또는 전혀 없습니다. 이는 경추완 통증 치료에서 이 두 가지 치료 옵션 간의 비교 효과를 결정하는 데 있어 흥미로운 점을 보여줍니다.
연구 유형
등록 (실제)
단계
- 2 단계
- 3단계
연락처 및 위치
연구 장소
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Carabobo
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Valencia, Carabobo, 베네수엘라, 02001
- Centro de Medicina Fisica y de Rehabilitacion FISIOREH
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
포함 기준:
- 자기공명영상으로 확인된 경상완 통증의 임상진단
- 치료를 적용하기 전 최소 연속 3개월 동안 상지의 팔 통증, 감각 이상 또는 무감각의 편측 증상이 존재합니다.
- 다음 테스트 모두에서 양성 결과: Spurling, Distraction, and Upper Limb
제외 기준:
- 비스테로이드성 항염증제(NSAIDs) 사용에 대한 금기
- 통증 완화를 위해 모든 유형의 치료, 요법, 절차 또는 약물 사용
- 항경련제, 항우울제 또는 향정신성 약물을 복용 중인 환자
- 척추 불안정
- 척추 골다공증
- 척추 또는 척추 감염.
- 유전적, 감염성 또는 신생물성 기원의 신경학적 질환
- 자궁 경부 협착증 척수병증
- 임신
- 운동공포증
- 내분비 장애 및 폐경기
- 척추 수술의 역사
- 지적 장애, 심각한 정신 질환, 중독, 심한 수면 부족, 알츠하이머병.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 평행한
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 정중신경 신경동원화
연속 6주 동안 주 5회(월요일~금요일) 15분 정중 신경 가동화 세션 정중 신경 신경 가동화 절차에 적용되는 팔꿈치 확장의 최대 정도는 Universal Goniometer Device를 사용하여 결정되었습니다.
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비수술적 비침습적 정중신경 신경가동술은 신경가동술을 2분간 적용할 때마다 1분의 휴식을 취하고 5번에 걸쳐 2분 동안 물리치료사에 의해 지속적으로 적용되었습니다.
개입은 6주 동안 적용되었습니다.
정중신경 신경가동화 치료 시 증상 재현 없이 팔꿈치 신전 운동의 최대 정도는 Universal Goniometer Device를 기본으로 사용하여 결정하였다.
다른 이름들:
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ACTIVE_COMPARATOR: 이부프로펜
환자의 내약성에 따라 매일 400mg의 경구용 이부프로펜 단일 용량을 최대 1200mg/일까지 증량하여 6주 연속 동안 매 8시간마다 약물의 3회 경구 섭취로 균등하게 나눕니다.
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활성 비교군은 이부프로펜 경구 치료를 받았습니다.
시작 용량은 400mg/일이었고 환자의 내성에 따라 8시간마다 3회 경구 섭취로 나누어 최대 1200mg/일까지 증량했습니다. 개입은 6주 동안 적용되었습니다.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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1시간에 통증에 대한 숫자 등급 척도를 사용하여 기준선에서 변경
기간: 개입 세션 1, 15 및 30에 해당하는 기준선 및 치료 적용 후 1시간
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NRS(Numeric Rating Scale)는 환자가 통증을 자가 보고하는 11점 척도이며 경추완 통증 증상의 존재 및 완화를 평가하기 위해 사용되었습니다.
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개입 세션 1, 15 및 30에 해당하는 기준선 및 치료 적용 후 1시간
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Quik DASH 척도를 사용하여 영향을 받는 상지와 관련된 신체 기능의 기준선으로부터의 변화
기간: 기준선에서 개입 세션 1 및 30 치료에 해당합니다.
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팔, 어깨, 손의 장애(QuickDASH) 테스트는 상지의 여러 근골격계 장애가 있는 사람들의 신체 기능과 증상을 측정하기 위해 고안된 자가 보고식 짧은 설문지입니다.
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기준선에서 개입 세션 1 및 30 치료에 해당합니다.
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1시간에 기준선 경추 회전 운동 범위에서 변경
기간: 개입 세션 1 및 30에 해당하는 기준선 및 치료 적용 후 1시간
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경추 운동 범위 장치(CROM)를 사용하여 회전 각도 단위로 경추 회전을 평가했습니다.
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개입 세션 1 및 30에 해당하는 기준선 및 치료 적용 후 1시간
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
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