Effects of Health Education for Patients Received Minimally Invasive Lumbar Spinal Surgery
2019년 10월 7일 업데이트: Taipei Medical University Shuang Ho Hospital
Lumbar degenerative disease surgery has been a routine clinical operation, and has good treatment effects.
Although the patient's neurological symptoms improve after surgery, many patients still have postoperative muscle soreness.
The postoperative rehabilitation intervention for the patients receiving traditional lumbar surgery has been confirmed to effectively improve pain and disability.
However, in recent years, minimally invasive lumbar spinal surgery has gradually replaced traditional surgery, postoperative pain has been greatly reduced.
Therefore, patients have the opportunity to receive early intervention in rehabilitation, but there is no standardization process for rehabilitation of minimally invasive lumbar spine surgery.
Therefore, this study aims to establish a health education program for patients receiving minimally invasive lumbar spinal surgery, and conduct clinical trials to test its effectiveness.
연구 개요
연구 유형
중재적
등록 (예상)
100
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Taipei, 대만, 235
- 모병
- Taipei Medical University-Shuang Ho Hospital
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연락하다:
- Chiao-Ling Chen, Master
- 전화번호: 8127 886-02-22490088
- 이메일: 18395@s.tmu.edu.tw
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
45년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Age between 45 and 90 years old.
- Low back pain has been persisting at least 3 months.
- Clinical degeneration diagnosis supports the need of MI-TLIF.
- Able to understand Chinese.
Exclusion Criteria:
- Emergency surgery.
- Unstable vital sign.
- Any psychological, neurological, orthopedics, cardiopulmonary, and cancer history.
- Had spinal surgery before.
- Pregnancy.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: 평소 케어 그룹
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실험적: 교육그룹
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Physical therapist will be consulted one day before and after the operation (OP) day.
On the day before the OP day, they focus on education, including how to get up from bed and stand up from a chair.
Five rehabilitation exercises are also demonstrated: 1) ankle flexion and extension, 2) knee flexion and extension, 3) hip joint abduction and adduction, 4) hip joint flexion and extension, and 5) drawing-in maneuver.
The participants will be required to repeat each component to confirm that they can do it correctly.
Each exercise is suggested to be done 10 times per day following MI-TLIF, and the number will be recorded 3 days (pre-OP day, post-OP day, and post-OP day 2).
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change of Oswestry Disability Index
기간: The day before operation day, and 1, 3, 6 months after surgery
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This scale evaluates subject's physical function.
The range is 0 to 1. Higher values represent a better outcome.
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The day before operation day, and 1, 3, 6 months after surgery
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Change of Visual Analogue Scale
기간: The day before operation day, and 1, 3, 6 months after surgery
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This scale evaluates subject's pain intensity.
"0" indicates no pain and "10" indicates the worst possible pain.
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The day before operation day, and 1, 3, 6 months after surgery
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Change of Short Form 12 version 2
기간: The day before operation day, and 1, 3, 6 months after surgery
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This scale evaluates subject's health-related quality of life.
We will record the subscales: physical component summary (PCS) and mental component summary (MCS).
Higher values represent a better outcome.
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The day before operation day, and 1, 3, 6 months after surgery
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Change of Functional reach test
기간: The day before operation day, and 1, 3, 6 months after surgery
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It is a dynamic measure of balance.
A 100 cm yardstick will be horizontally set on the wall with the acromion height.
The patient will be asked to make a fit and reach forward as far as possible without moving his/her feet.
It will be measured twice and the better outcome will be recorded.
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The day before operation day, and 1, 3, 6 months after surgery
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Change of 30-second Chair Rise
기간: The day before operation day, and 1, 3, 6 months after surgery
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It is used to evaluate the lower limb function and strength relating to the daily activities.
The patient starts with a sitting position, and need to repeat stand-to-sit movements.
He/She will be encouraged to move safely as soon as possible in 30 minutes.
Higher number indicates better function.
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The day before operation day, and 1, 3, 6 months after surgery
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Change of Timed Up and Go test
기간: The day before operation day, and 1, 3, 6 months after surgery
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It was developed to measure subjects' balance and mobility.
The patient starts with a sitting position, stands up, walks a 3-meter distance, turns, walks back, and sits down.
He/She will be encouraged to finish it safely as soon as possible.
A shorter time indicates better function.
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The day before operation day, and 1, 3, 6 months after surgery
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Change of 15-m walk test
기간: The day before operation day, and 1, 3, 6 months after surgery
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Gait speed shows good reliability and is valid to assess physical mobility.
A 15-mile straight line will be mounted on a flat surface.
The patient will be required to walk down the line at the maximal speed.
He/She will be encouraged to finish it safely as soon as possible.
A shorter time indicates better function.
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The day before operation day, and 1, 3, 6 months after surgery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Length of hospitalization
기간: The duration between admission and discharge
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The duration between admission and discharge
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Narcotic use during hospitalization
기간: The duration between admission and discharge
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The duration between admission and discharge
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Return-to-work status
기간: up to 6 months after surgery
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up to 6 months after surgery
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Adverse events
기간: up to 6 months after surgery
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The rate of infection and the rate of re-operation (including: dural tear, cage migration and retropulsion, and screw loosening).
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up to 6 months after surgery
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 의자: Heng-Wei Liu, Doctor, Shuangho Hospital
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2019년 4월 25일
기본 완료 (예상)
2021년 10월 1일
연구 완료 (예상)
2022년 1월 1일
연구 등록 날짜
최초 제출
2019년 10월 6일
QC 기준을 충족하는 최초 제출
2019년 10월 7일
처음 게시됨 (실제)
2019년 10월 9일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 10월 9일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 10월 7일
마지막으로 확인됨
2019년 10월 1일
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. .