- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04047056
Effectiveness of Laboral Kinesiotherapy in Prevention of Upper Limb Musculoskeletal Disorders
Analisys of the Effectiveness of Laboral Kinesiotherapy in Prevention of Upper Limb Musculoskeletal Disorders in the Workers of a University Hospital
ABSTRACT
Work-related musculoskeletal disorders are seen as a public health problem, and can often lead to temporary or permanent incapacity to work. Exercises can be indicated to prevent musculoskeletal disorders, allied to ergonomic intervention as a preventive approach. Objectives: The objective of this study is to analyze the effects of workplace muscle strengthening kinesiotherapy in the reduction of pain and discomfort in the upper limbs and cervical region perceived by the workers of a university hospital. Methods: After a priori sample size calculation based on pain numeric scale, 166 volunterrs will be recruted and assigned randomly to the "labor kinesiotherapy" group (GCL) or to the "control group" (CG), considering 10% sample size lost and intention to treat. The primary outcomes will be the pain perceived by the Numerical Pain Scale (NDT) and Nordic Questionnaire, and isokinetic muscle strength through the mean peak torque work of shoulder abduction. The discomfort and disability will be evaluated by the PSFS and QuickDASH questionnaires. The Ergonomic Analysis of Work will be evaluated by the manual "Ergonomic Analysis Focused on Activities" - EAFA and application of QEC, RULA, REBA and HARM tools. Statistical analysis will be performed through PASW Statistics ™, version 20.0. The independent sample T test will be used to compare the groups. The Cohen index will be set for the effect size calculation. All analyzes will be conducted with 95% confidence interval and p <0.05 significance.
연구 개요
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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São Paulo
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Ribeirão Preto, São Paulo, 브라질, 14031390
- 모병
- Natalia Claro da Silva
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연락하다:
- Marisa CR Fonseca
- 전화번호: +55 (16) 3602-4413
- 이메일: marisa@fmrp.usp.br
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Workers who have or do not have musculoskeletal complaints in the cervical, shoulder, elbow, wrist or hand and / or fingers, without clinical diagnosis and who are not away from their professional activities.
Exclusion Criteria:
Workers presenting:
- Pregnancy;
- Congenital abnormality of the spine and significant musculoskeletal deformities (such as amputation, dysmetria);
- Severe cervical spine disorders, postoperative conditions in the neck or upper limb region;
- Uncontrolled cardiovascular disease, cardiac arrhythmia, angina or related symptoms, and postural hypotension or other contraindications to exercise;
- Workers who engage in some form of regular physical activity involving muscle strengthening and endurance exercises.
- Workers who have a proven diagnosis of upper limb musculoskeletal dysfunction and are undergoing physical therapy treatment.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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위약 비교기: Ergonomic Guidelines Manual
A manual of ergonomic occupational and daily living guidelines will be given to both control and labor kinesiotherapy groups, which is the only approach for the control group initially.
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The intervention group will perform 5 minutes of warm-up with free active exercises, 10 minutes of specific resistance exercises for the cervical and upper limbs and 5 minutes of stretching and muscle relaxation.The initial free active exercises will be performed in 3 sets of 15 repetitions; Resistance exercises will be performed in 3 sets of 10 repetitions and stretching will be performed in 3 sets of 30 seconds. Regarding the intervals between exercises, active recovery will be adopted to counteract the effects of muscle fatigue. |
활성 비교기: Labor Kinesiotherapy in group
The intervention will be performed by a physical therapist, which will consist of preparatory labor kinesiotherapy, which aims to prepare the workers' osteo-articular system for the beginning of the work activity, acting more specifically on those muscle groups that will be most required during the journey which will be identified in the evaluation.
Labor kinesiotherapy will be performed in the workplace before the workday and will last 20 minutes, 3 times a week, for 12 weeks.
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The intervention group will perform 5 minutes of warm-up with free active exercises, 10 minutes of specific resistance exercises for the cervical and upper limbs and 5 minutes of stretching and muscle relaxation.The initial free active exercises will be performed in 3 sets of 15 repetitions; Resistance exercises will be performed in 3 sets of 10 repetitions and stretching will be performed in 3 sets of 30 seconds. Regarding the intervals between exercises, active recovery will be adopted to counteract the effects of muscle fatigue. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Numerical Pain Scale - NPS
기간: 12 weeks.
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Difference in numerical pain scale in the 3 evaluations.
The numerical pain scale score ranges from 0 to 10, with values closer to 10 indicating worse pain.
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12 weeks.
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shoulder abduction Torque peak in the Isokinetic Dynamometer
기간: 12 weeks.
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Mean difference in torque peak achieved by the Isokinetic Dynamometer at baseline and after 12 weeks.
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12 weeks.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Quick Disabilities of de Arm, Shoulder and Hand (QuickDAS)
기간: 12 weeks.
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Difference in DASH questionnaire scores in 3 evaluations.
The QuickDASH score ranges from 0 to 100, with values closer to 100 indicating better health.
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12 weeks.
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Patient Specific Functional Scale (PSFS)
기간: 12 weeks.
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Difference in PSFS questionnaire scores in 3 evaluations.
The PSFS allows patients to report on their functional status at baseline and at a follow-up session, to determine if a meaningful change in functional status has occurred.
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12 weeks.
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공동 작업자 및 조사자
간행물 및 유용한 링크
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. .
Labor Kinesiotherapy에 대한 임상 시험
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University of California, San FranciscoMount Zion Health Fund완전한