- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01570127
Efficacy and Safety Study of Individualized and Standardized Acupuncture Treatment for Low Back Pain
Clinical Trial to Evaluate and Compare the Efficacy and Safety of Individualized and Standardized Acupuncture for Low Back Pain Patients: Randomized, Double-blind, Controlled Study
연구 개요
상세 설명
To determine whether individualized acupuncture is more effective than standardized acupuncture, 276 Low Back Pain patients will be recruited and randomly assigned to 4 separate groups.
Experimental groups(Individualized Acupuncture Group and Standardized Acupuncture Group) and Control groups (Sham acupuncture and waiting list)
The change of pain and physical functions will be compared among the four groups.
So the efficacy of acupuncture, and the best acupuncture treatment model will be determined. Also in addition, safety and abnormal reactions of acupuncture treatments will be evaluated.
연구 유형
등록 (예상)
단계
- 2 단계
연락처 및 위치
연구 장소
-
-
-
Seoul, 대한민국, 130-872
- 모병
- Kyung Hee University Oriental Medicine Hospital
-
연락하다:
- Dongwoo Nam, Ph.D
- 전화번호: +82-2-958-1827
- 이메일: hanisanam@hanmail.net
-
부수사관:
- Dongwoo Nam, Ph.D
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Male and female patients suffering Low Back Pain.
- Patients classified as Class 1(pain in the lumbar area, without radiation below the gluteal fold and in the absence of neurologic signs) or Class 2(Low back pain with radiation of pain not beyond the knee, no neurological signs) according to the Quebec Task Force System
- Suffering pain which is more than 40mm on VAS(Visual Analog Scale)
- Voluntary participants who have completed the consent.
Exclusion Criteria:
- Low back trauma history within 6 months.
- Low back surgery history within 6 months.
- Low back pain caused by malignancy, inflammatory disease, fibromyalgia, vertebral fracture, infection, juvenile scoliosis or congenital malformation.
- Pain in other parts of the body more severe than low back pain.
- Mental problems that can influence the pain or results of questionnaire.
- Diseases that can interfere absorption, metabolism and excretion of medicine.
- History of alcohol or drug abuse within 12 months of the study.
- Pregnant, breastfeeding or childbearing aged women who are not using any birth control methods.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Individualized Acupuncture
The patients in this group received individualized acupuncture prescribed by a certified Korean Medicine Doctor with more than 6 years of oriental medicine college education and 2 years of clinical experience.
The acupuncture formulas were composed based on the pattern diagnosis, which is an unique diagnosis system of Oriental Medicine.
|
치료는 주 2회 20분씩 6주간(12회)
|
실험적: 표준화된 침술
이 그룹의 환자들은 6년 이상의 한의대 교육과 2년의 임상 경험을 가진 공인된 한의사가 적용한 동일한 경혈을 사용하여 표준화된 침 치료를 받았다.
침술 공식은 RCT의 문헌 검토를 기반으로 구성되었습니다.
|
The treatment was applied twice a week for 20 minutes for 6 weeks(12sessions) 8 Acupuncture points, GV4, GV3, BL24(bilateral), BL25(bilateral) and GB30(bilateral) were used for all the patients assigned to this group.
Sterile Stainless Steel(25mm x 40mm) disposable acupuncture needles manufactured by Dong-Bang Acupuncture Co.(Korea) were used.
|
가짜 비교기: 가짜 침술
비관통성 침술 장치인 박샴침을 환자들에게 적용하였다.
침술의 외형은 같지만 침이 피부를 관통하지 않는다.
|
The treatment was applied twice a week for 6 weeks(12sessions).
The sham acupuncture was applied on the 8 same acupuncture points as in the standardized acupuncture group, GV4, GV3, BL24(bilateral), BL25(bilateral) and GB30(bilateral).
Each session was 20 minutes long.
다른 이름들:
|
간섭 없음: 대기 중
이 그룹의 환자들에게는 중재가 적용되지 않았습니다.
방문할 때마다 평가만 이루어졌습니다.
|
이 그룹의 환자들에게는 중재가 적용되지 않았습니다.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
The change of 100mm pain Visual Analog Scale(VAS) after 6 weeks of treatment.
기간: at baseline and after 6 weeks of treatment.
|
Visual analog scale (VAS) is a tool used to measure pain.
The patient is asked to indicate their perceived pain intensity along a 100 mm horizontal line, where '0' represents 'no pain' and '100', 'unbearable pain'.
The change of pain will be reported by comparing the mean VAS before treatment and after the 6 week trearment period.
|
at baseline and after 6 weeks of treatment.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Roland - Morris Disability Questionnaire
기간: at 2nd(baseline), 8th(after 4 weeks of treatment), 13th(end of study) and 14th(follow up) visit
|
Roland - Morris Disability Questionnaire (RMDQ) is scored by adding up the number of items checked by the patients, among the 24 items concerning various disablilities caused by low back pain.
The score can therefore vary from 0 to 24.
Higher the scores represent worse disabilities.
|
at 2nd(baseline), 8th(after 4 weeks of treatment), 13th(end of study) and 14th(follow up) visit
|
SF-36
기간: at 2nd(baseline), 8th(after 4 weeks of treatment), 13th(end of study) and 14th(follow up) visit
|
The 36 questions yields an 8-scale health profile.
It is useful in monitoring the change in health related quality of life.
|
at 2nd(baseline), 8th(after 4 weeks of treatment), 13th(end of study) and 14th(follow up) visit
|
Adverse Events
기간: at 2nd(baseline), 3rd, 4th, 5th, 6th, 7th, 8th, 9th, 10th, 11th, 12th and 13th(end of study)
|
Any unpredicted symptoms were checked at each follow up visit and if any, the symptom, time of occurrence, and length of duration were recorded and reported.
|
at 2nd(baseline), 3rd, 4th, 5th, 6th, 7th, 8th, 9th, 10th, 11th, 12th and 13th(end of study)
|
공동 작업자 및 조사자
스폰서
수사관
- 연구 의자: Jae-Dong Lee, Ph.D, Kyunghee University Medical Center
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- KOMCIRB-02-20101130-02
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
하부 요통에 대한 임상 시험
-
FibroGenAstraZeneca; Astellas Pharma Inc종료됨기본 MDS(Very Low, Low 또는 Intermediate IPSS-R with미국, 호주, 벨기에, 독일, 이스라엘, 이탈리아, 대한민국, 러시아 연방, 스페인, 영국, 프랑스, 칠면조, 캐나다, 덴마크, 인도, 폴란드
-
Université Victor Segalen Bordeaux 2Nanox International Laboratory (Belgique)완전한
-
Eisai Inc.완전한LEC(Low Emetogenic Chemotherapy)를 받기 위해 확인된 악성 질환이 있는 환자 또는 LEC의 마지막 주기 동안 최소한 메스꺼움 및 구토를 경험한 환자미국
개별화된 침술에 대한 임상 시험
-
Duke UniversityNational Heart, Lung, and Blood Institute (NHLBI); RTI International완전한