- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01346423
Interdisciplinary Intervention Versus Brief Intervention for Patients With Musculoskeletal Pain
Is Interdisciplinary Intervention for Patients Sicklisted With Musculoskeletal Pain More Effective in Helping Patients Back to Work Than Than The Less Resource Demanding Brief Intervention Method?
Musculoskeletal pain is very common in the normal population, and the reason for about 50 % of the long term sickness absence in Norway. Most of these patients have common, but troublesome subjective health complaints where pathological findings are absent or substantially less than expected compared to the reported intensity of the complaints. Psychosocial factors are important in the development of chronic complaints. In a large meta-analysis job satisfaction was found to be associated with mental health and subjective physical health. Individual factors are also important. Uncertainty related to the understanding of pain mechanisms, treatment strategies and management contribute to the problem.
Among patients sicklisted for musculoskeletal complaints, low back pain is the largest diagnose group. Most of these patients also have many other complaints. Previous studies have shown that for low back pain patients a brief intervention at a spine clinic with examination, information, reassurance, and encouragement to engage in physical activity as normal as possible, had significant effect in reducing sick leave. Other studies have shown that multidisciplinary rehabilitation for chronic low back pain has effect on sick leave. A Danish study from Arbeidsmiljøinstituttet report that interdisciplinary treatment for patients sicklisted for musculoskeletal complaints, had effect on socio-economic costs, pain, and function.
A treatment team consisting of various professionals is expensive, and in this study we will compare the simple, standardized brief intervention model with the more resource demanding interdisciplinary treatment for patients sicklisted for musculoskeletal complaints.
Research question / hypothesis: An interdisciplinary treatment model for musculoskeletal complaints - is it beneficial for reducing sickness absence?
연구 개요
상세 설명
In 2007 The Government in Norway raised a fund to support efforts to reduce sickness absence, called "Raskere tilbake prosjekt". Helse Sør-Øst was invited to establish projects within their health care system, and the department of physical medicine and rehabilitation at Sykehuset Innlandet HF was assigned the task to constitute an outpatient-clinic for musculoskeletal diseases.
This initiative opened possibilities to explore new strategies based on science and own clinical experience to help these patients back to work without being confined to the traditional diagnose related examination and treatment offered in most clinics. In this project the main focus is directed towards work and barriers for working life. Because sickness absence often is multicausal and needs a bio-psycho-social approach, this should be reflected in the composition of the treatment team.
There is a great demand to make out how complex bio-psycho-social problems can be solved, organized, implemented, and have economic gains for the society. To answer these questions we need randomized controlled clinical studies, and we need documentation when new treatment models are offered to this group of patients.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Ottestad, 노르웨이, 2312
- Dep. of Physica. Medicin and Rehabilitation, Innlandet Hospital Trust
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Musculoskeletal diagnosis
- Minimum 50% sick leave from work for not more than one year
- Minimum 50 % employed
Exclusion Criteria:
- Not sicklisted
- Sicklisted less than 50%
- Sicklisted > 1 year
- Less than 50% employed
- Pregnancy
- Does not speak Norwegian
- Psychiatric disease
- Osteoporosis
- Cancer disease
- Rheumatic disease
- Ongoing Insurance Compensation Case
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 |
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실험적: Intervention group
Treatment team with a physician, a physiotherapist, a social service worker.
The main goal for the team is to make a survey of the patient's situation, in which the biomedical tradition to make a diagnosis is replaced by a disability diagnosis, with systematically identification of barriers for return to work.
The patient meets at the outpatient clinic three times; at baseline, after 2 weeks and after 3 months.
One year after baseline the patient has a telephone-follow-up.
At baseline, the patient and the team works out a rehabilitation plan and in this process a new visual, educational tool is central.
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Interdisciplinary collaboration deals with tasks often complex which require different skills to make a wide assessment.In this study the treatment team consists of a physician, a physiotherapist and a social service worker.
The main goal for the team is to make a survey of the patient's situation, in which the biomedical tradition to make a diagnosis is replaced by a disability diagnosis, with systematically identification of barriers for return to work.
The conclusion of the team will be followed by a targeted rehabilitation plan.
Factors assessed to be the major cause of the reduced function at work will have priority in the following rehabilitation process.
One of the team members will be responsible for the further process to follow the plan to help the patient back to work, in cooperation with the patient, the workplace, the general practitioner, and NAV.
다른 이름들:
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활성 비교기: Controll group
The brief intervention is a standardized intervention based on the studies by Indahl and Hagen.
Therapist treatment manuals will be written for the intervention.
The essential features are interview and examination by a specialist in physical medicine and rehabilitation.
Patients will be given time to express their concerns and problems in daily activities.
Unless symptoms and clinical findings indicate some serious disease, the patients will be informed about the good prognosis, and the importance of staying active to avoid development of muscle dysfunction.
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The brief intervention is a standardized intervention and the essential features are interview and examination by a specialist in physical medicine and rehabilitation.
Patients will be given time to express their concerns and problems in daily activities.
The examination is thorough with detailed feedback on findings and normal functions, and clear and consistent explanations on pain and defense mechanisms.
Somatic findings will be explained.Unless pathological findings, the patient will be encouraged to physical activity.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Sickness leave 1 year after inclusion
기간: At 12 months after baseline
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In addition to the main outcome we will also evaluate job satisfaction, social support, coping, defense mechanisms, illness perception, function level, activity of daily living, psychological distress, and health complaints/pain as recorded by the questionnaires at baseline.
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At 12 months after baseline
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공동 작업자 및 조사자
수사관
- 연구 의자: Eli M. Hagen, MD, PhD, Sykehuset Innlandet HF
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
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 (추정)
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. .
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