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临床试验/NCT05530902
NCT05530902招募中不适用

Multidisciplinary Primary Rehabilitation Care for Patients With Chronic Musculoskeletal Pain

Maastricht University Medical Center10 个研究点 分布在 1 个国家目标入组 1,400 人开始时间: 2022年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,400
试验地点
10
主要终点
Changes in perceived level of disability

研究概览

简要总结

Rationale: A great variability in treatment contents, ways of collaboration between healthcare professionals, and evaluation methods for the treatment in chronic musculoskeletal pain (CMP), exists. Currently, multidisciplinary diagnostics, pain education and treatment in primary care, in collaboration with secondary care, especially with a biopsychosocial approach, is barely or not organized for patients having CMP. Objective: The aim of this study is to gain insight into the feasibility, health care and societal costs, effects regarding the patients' functioning and participation and perceived quality of care of the multidisciplinary primary rehabilitation care (MPRC) for different organization structures.

详细描述

Chronic musculoskeletal pain (CMP) occurs in 18% of the Dutch population and may cause severe problems in daily functioning of patients. In 10% of the Dutch population, these problems are a leading cause of chronic disability, which leads to a high personal burden.

This will lead to high societal and health care costs. Most of these costs (80-90%) are the result of societal burden, such as work absenteeism, work productivity loss, social benefits and costs as a result of required (in)formal support from third parties (e.g. domestic help). According to the RIVM, the health care costs for neck and back pain are estimated at 937 million euro in 2017. This represents 14% of the total healthcare costs for musculoskeletal and tissue complaints and 1% of the total health care costs in The Netherlands.

The World Health Organization states that two-thirds of all conditions that need rehabilitation services comes from musculoskeletal disorders. With an ageing and growing population, the number people with musculoskeletal disorders increases fast, which will lead to a rapid increase of societal and health care costs. To decrease these costs, multidisciplinary rehabilitation workforce should be available. It is shown that multidisciplinary rehabilitation services in primary care and between primary care and secondary or tertiary care can be efficient. However, a great variability in treatment contents, ways of collaboration between healthcare professionals, and evaluation methods for the treatment in CMP exists.

The Dutch national care standard for CMP proposes an inventory of the factors contributing the causes and maintenance of pain and its associated limitations in daily functioning and participation. These factors can be divided in biomedical, psychological and societal factors: the biopsychosocial model. Since treatments focusing on this model have positive effects on patient outcomes, the standard recommends a biopsychosocial approach in designing a treatment plan. Thereby, the stepped care principles have to be taken into account for the treatment of CMP patient. In stepped care, the intensity of professional care is pre-defined. The stepped care principles contain the four following levels of care:

Step 1: prevention and self-management; Step 2: Monodisciplinary diagnostics, pain education and treatment in primary care; Step 3: Multidisciplinary diagnostics, pain education and treatment in primary care in collaboration with secondary care; Step 4: Multidisciplinary diagnostics, pain education and treatment in secondary or third care.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age≥18 years
  • musculoskeletal pain
  • duration of musculoskeletal pain ≥ 3 months
  • monodisciplinary primary care is completed

排除标准

  • previous experiences with treatment in multidisciplinary secondary or tertiary care
  • Co-morbidities limiting to complete the treatment program within the preset time
  • present addiction or other psychiatric problems
  • inadequate understanding of the Dutch language.

结局指标

主要结局

Changes in perceived level of disability

时间窗: At the start of the treatment (the diagnostic phase) (T0), at three months (T1); at nine months (T2) and at fifteen months (T3).

Measured with the Pain Disability Index (PDI) questionnaire

Changes in physical quality of life

时间窗: At the start of the treatment (the diagnostic phase) (T0), at three months (T1); at nine months (T2) and at fifteen months (T3).

Measured with the Physical Component Scale (PCS) of the SF-12 questionnaire

次要结局

  • Changes in health-related productivity losses(At the start of the treatment (the diagnostic phase) (T0), at three months (T1); at nine months (T2) and at fifteen months (T3).)
  • Changes in work ability(At the start of the treatment (the diagnostic phase) (T0), at three months (T1); at nine months (T2) and at fifteen months (T3).)
  • Changes in self efficacy(At the start of the treatment (the diagnostic phase) (T0), at three months (T1); at nine months (T2) and at fifteen months (T3).)
  • Changes in health care consumption(At the start of the treatment (the diagnostic phase) (T0), at three months (T1); at nine months (T2) and at fifteen months (T3).)
  • Changes in life participation(At the start of the treatment (the diagnostic phase) (T0), at three months (T1); at nine months (T2) and at fifteen months (T3).)
  • Changes in anxiety and depression(At the start of the treatment (the diagnostic phase) (T0), at three months (T1); at nine months (T2) and at fifteen months (T3).)
  • Changes in catastrophizing(At the start of the treatment (the diagnostic phase) (T0), at three months (T1); at nine months (T2) and at fifteen months (T3).)
  • Changes in satisfaction with care(At the start of the treatment (the diagnostic phase) (T0), at three months (T1); at nine months (T2) and at fifteen months (T3).)
  • Changes in complexity of musculoskeletal problems(At the start of the treatment (the diagnostic phase) (T0), at three months (T1); at nine months (T2) and at fifteen months (T3).)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (10)

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