- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04250974
Evaluaing the Effects of Electroacupuncture for Postoperative Pain Relief in Patients With Distal Radius Fracture
Single-blinded, Randomized Preliminary Study Evaluating the Effects of Electroacupuncture for Postoperative Pain Relief in Patients With Distal Radius Fracture.
Single-blinded, randomized preliminary study evaluating the effects of electroacupuncture for postoperative pain relief in patients with distal radius fracture.
Distal radius fracture is extremely common, and it is about 10% of all fractures in the human body. Therefore, the distal radius is the most frequently fractured part of the upper limbs of the human body. Once the fracture occurs, internal fixation is the main surgical procedure. The postoperative analgesic method is generally oral or injection analgesic. In recent years, electroacupuncture(EA) has been widely used to relieve pain after surgery, and many studies have confirmed that it is effective. However, there is no evaluation of analgesic efficacy after the surgery of distal radius fracture. Therefore, it is hoped that the efficacy of EA for analgesia after the surgery of distal radius fracture is demonstrated by this study. And, the investigators also hope the investigators can reduce the use of painkillers through EA.
Methods: It is expected that 30 patients will be randomly assigned to the following groups: EA group,EA at points; non-point group, EA at non-points, control group without EA
- EA group:EA at points after surgery
- non-point group: EA at non-points after surgery
- Control group: no EA
연구 개요
상세 설명
Single-blinded, randomized preliminary study evaluating the effects of electroacupuncture for postoperative pain relief in patients with distal radius fracture.
Distal radius fracture is extremely common, and it is about 10% of all fractures in the human body. Therefore, the distal radius is the most frequently fractured part of the upper limbs of the human body. Once the fracture occurs, internal fixation is the main surgical procedure. The postoperative analgesic method is generally oral or injection analgesic. In recent years, electroacupuncture(EA) has been widely used to relieve pain after surgery, and many studies have confirmed that it is effective. However, there is no evaluation of analgesic efficacy after the surgery of distal radius fracture. Therefore, it is hoped that the efficacy of EA for analgesia after the surgery of distal radius fracture is demonstrated by this study. And, the investigators also hope the investigators can reduce the use of painkillers through EA.
Methods: It is expected that 30 patients will be randomly assigned to the following groups: EA group,EA at points; non-point group, EA at non-points, control group without EA
- EA group:EA at points after surgery
- non-point group: EA at non-points after surgery
- Control group: no EA Mode of operation: After the patient has returned to the recovery room, perfom EA, and take the needle after 30 minutes. Perform another 30 minutes after 24 hours, and then statistics.
Acupoint selection:
- true acupoints: needles were inserted to Taichong (LR3 ) and Taixi (KI3) contralateral to the operated leg and deqi sensation elicited at acupoints
- false point: the needles were inserted to Kunlun(BL60) and Shugu(BL65) contralateral to the operated leg and deqi sensation elicited at acupoints
Data collection:
- Record the time required for the first injection of analgesics
- The number of doses of oral painkiller used in 36 hours after surgery (count)
- The number of doses of injection painkiller used in 36 hours after surgery (count)
- Use the visual analog scale (VAS) to assess the patient's pain level
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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No. 2, Yude Rd, North District, Taichung City
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Taichung, No. 2, Yude Rd, North District, Taichung City, 대만, 404
- 모병
- China Medical University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Orthopaedic specialist diagnoses distal radius fracture and undergoes internal fixation
- Age between 20 and 70
Exclusion Criteria:
- Allergic to painkillers
- Have a serious heart rhythm
- epilepsy
- Severe pulmonary heart disease
- History of mental illness
- History of drug abuse
- received acupuncture treatment within 1 month
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: electroacupuncture
electroacupuncture at points after surgery
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전기 침술
|
|
가짜 비교기: electroacupuncture non-point
electroacupuncture at non-points after surgery
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전기 침술
|
|
간섭 없음: Control group
only oral or injection painkiller were used after surgery
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
the time required for the first injection of analgesics
기간: in 36 hours after surgery
|
Record the time required for the first injection of analgesics
|
in 36 hours after surgery
|
|
the number of doses of injection painkiller
기간: in 36 hours after surgery
|
Record the number of doses of injection painkiller
|
in 36 hours after surgery
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .