- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01779544
Rehabilitation After Lumbar Disc Surgery: Exercise Therapy and Brief Educational Intervention
Rehabilitation After Lumbar Surgery
Rehabilitation after lumbar disc surgery (prolapse) focuses on various elements such as endurance, strength, stretching and information. Evidence concludes that it is not harmful to return to activity after lumbar disc surgery, and restrictions to activities after these operations are today more or less nonexistent. Some studies have shown that high intensity programs might be more effective, but they are probably more expensive. In recent years cognitive interventions have received more attention in rehabilitation programs after lumbar disc surgery. The cognitive approach is focused on providing patient knowledge to reduce uncertainty so that he or she can understand what is important after lumbar disc surgery so that belief in self-efficacy increases. A goal of the rehabilitation is to get the patient to resume normal activities. Reviews ask for how much treatment are needed in a rehabilitation program after lumbar disc surgery.
The study will be a randomized clinical trial. The study will compare two different post-operative rehabilitation programs (general information or general information + exercise therapy). Both groups will begin treatment 1 day after surgery. Subjects in exercise therapy group are supposed to continue with exercises 3 months.
In this study the following hypothesis will be studied:
- Brief intervention, an educational model, alone after lumbar disc surgery do have the same effect on pain in legs and low back as brief intervention, an educational model, combined with exercise therapy.
- Exercises which are instructed after lumbar disc surgery in a rehabilitation program, are being done by the patients.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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-
Hordaland
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Bergen, Hordaland, 노르웨이
- Haukeland University Hospital, Ortopedisk klinikk, Kysthospitalet i Hagevik
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Diagnosed with lumbar disc prolapse with radicular pain
- Age between 18 and 60
Exclusion Criteria:
- Previous lumbar disc surgery (prolapse)
- Spondyloarthritis
- Arthritis
- Systematic disease
- Heart disease
- Does not understand Norwegian language, spoken or in writing
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Brief intervention only
Brief intervention, an educational model, consists of information
|
The goal of the the brief intervention is to provide the patient knowledge to reduce uncertainty so that he or she can understand what is important after lumbar disc surgery so that belief in self-efficacy increases.
|
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활성 비교기: Exercise group
Brief educational intervention combined with exercise therapy
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The goal of the the brief intervention is to provide the patient knowledge to reduce uncertainty so that he or she can understand what is important after lumbar disc surgery so that belief in self-efficacy increases.
Patients are instructed to do prescribed exercises the first 3 months after surgery, and to log when they do these
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Change from baseline in pain in the low back and the legs at 6-8 weeks and 1 year postsurgery
기간: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
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Baseline, 6-8 weeks postsurgery and 1 year postsurgery
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Disability and beliefs about the condition
기간: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
|
Baseline, 6-8 weeks postsurgery and 1 year postsurgery
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|
Change from baseline in Oswestry Disability Index at 6-8 weeks and 1 year postsurgery
기간: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
|
Baseline, 6-8 weeks postsurgery and 1 year postsurgery
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Change from baseline in Tampa scale of Kinesiophobia (TSK-13) at 6-8 weeks and 1 year postsurgery
기간: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
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Baseline, 6-8 weeks postsurgery and 1 year postsurgery
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Change from baseline in Fear-Avoidance Beliefs Questionnaire (physical activity) at 6-8 weeks and 1 year postsurgery
기간: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
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Baseline, 6-8 weeks postsurgery and 1 year postsurgery
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Change from baseline in anticipation to return to work at 6-8 weeks postsurgery
기간: Baseline and 6-8 weeks postsurgery postsurgery
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Baseline and 6-8 weeks postsurgery postsurgery
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Change from baseline in health condition at 6-8 weeks and 1 year postsurgery
기간: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
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Baseline, 6-8 weeks postsurgery and 1 year postsurgery
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Change from baseline in health condition rating at 6-8 weeks and 1 year postsurgery
기간: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
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Baseline, 6-8 weeks postsurgery and 1 year postsurgery
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Recidive prolapse
기간: 1 year postsurgery
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1 year postsurgery
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공동 작업자 및 조사자
수사관
- 연구 책임자: Kari Indrekvam, phd, MD, Helse Bergen HF, Haukeland University Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2012/1861
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. .
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