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临床试验/NCT02248363
NCT02248363Unknown不适用

Nationwide Evaluation of Multimodal Rehabilitation in Patients With Chronic Musculoskeletal Pain: Treatment Effectiveness and Prediction

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 6,500 人开始时间: 2014年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
6,500
试验地点
1
主要终点
Health-related quality of life (SF-36)

研究概览

简要总结

Chronic pain is a common health problem that causes enormous social costs. A common method for treating patients with chronic pain problems are multimodal rehabilitation (MMR), which consists of a combination of physical exercise, cognitive behavioural therapy and work training coordinated in an interdisciplinary team. Our research aims to evaluate the effectiveness of MMR on health, quality of life, physical activity, return to work and health economics, with the long-term goal of developing MMR. We aim also to evaluate predictive factors for good and bad treatment outcomes in order to better adapt the MMR to the patient. The project is based on patient-reported data from the Swedish Quality Registry for Pain Rehabilitation, which routinely collects data from 40 (2017) Swedish specialist MMR clinics from all parts of the country. We expect increased knowledge of treatment effects and how MMR can be effectively adapted according to the patient's limitations and resources. Our project group is interdisciplinary and is active in nationwide research networks that focus on chronic pain and rehabilitation.

详细描述

Chronic musculoskeletal pain is a public health problem, which frequently cause long-term sickness absence (>180 days). Societal costs of chronic pain are immense, with direct and indirect costs amounting to 90 billion Swedish crowns per year according to Swedish Council on Technology Assessment (SBU). Despite this, few policies have aimed specifically at chronic pain as a public health problem, also acknowledged in the later literature. Multimodal rehabilitation (MMR) is an increasingly used method in this patient group and denotes a combination of psychological measures, physical activity/exercise and manual or physical methods, administered by multidisciplinary teams. Its approach considers the patient's needs from a bio-psycho-social perspective, including work or employment status. At date, MMR is commonly offered by a number of specialist clinics throughout Sweden, of which more than 95% (currently 40) are connected to the Swedish Quality Registry for Pain Rehabilitation (SQRP) with the purpose to collect data for work with quality improvement and research.

According to the latest report from SBU, medium to high evidence from available research supports that MMR is effective for patients with chronic pain, with a few studies suggesting that MMR is superior to traditional and single-treatment programs. However, there is a paucity in the scientific literature with respect to how MMR should be designed to optimize results, and comparisons between different MMR designs or durations are limited. This void is a cause for uncertainty which delays improvement of existing MMR programs treating patients with chronic pain. Further, it is necessary to investigate whether reported results from RCTs and systematic reviews truly apply to naturalistic practice settings with a consecutive non-selective flow of patients, which may be done using a research methodology known as practice-based evidence through prospective observational cohort study designs. Our intention with the present research program is therefore to clarify effectiveness of different MMR designs. Furthermore, knowledge on risk predictors of poor treatment outcomes, and how long-term pain can be prevented and treated is greatly limited. Here, it is currently unclear what factor, patient related and/or treatment component, are more or less effective in different subgroups of patients with chronic pain. This has been discussed in the national SQRP-network and is in demand in the scientific literature. Knowledge of this will enable MMR providers to customize treatment according to patient profile in order to maximize treatment outcomes in relation to costs.

The overall aim of this research program is to prospectively evaluate multimodal rehabilitation (MMR) in patients with chronic pain conditions. The long-term goal is to develop and implement updated knowledge into Swedish MMR programs. The following two strategic aims will be targeted: 1) effectiveness of MMR programs with different durations (short, moderate and long-duration) , 2) prediction and risk of positive and negative outcomes, respectively.

Methods Study design This research project is carried out with longitudinal cohort-study designs based on data extracted from the Swedish Quality Registry for Pain Rehabilitation (SQRP; www.ucr.uu.se/nrs). Data covering several years will be used to analyse the effects of MMR. We expect a large sample size, it entail high test-power for the analyses of overall effects. Therefore, in addition to tests of statistical significance, effect sizes will be calculated in order to avoid type I error, i.e. avoid to falsely claiming that effect exists with support the support of p-values in such large sample. Included subjects are patients aged between 16 and 67 with a referral to a MMR clinic (specialist clinic) for chronic musculoskeletal pain problems.

Data from SQRP allows for longitudinal evaluation of treatment effects, prediction analyses. SQRP is a registry mainly covering patient-reported questionnaire data intended for health care research and quality work for healthcare providers that offer MMR. SQRP is connected to the Swedish Association of Local Authorities and Regions (Sveriges Kommuner och Landsting) and part of a system of national quality registries in Sweden (www.kvalitetsregister.se). Currently, 40 Swedish MMR specialist-treatment units (representing over 95% of the pain rehabilitation centres in the country) are associated with the registry and continuously transmit their patient data to SQRP (www.ucr.uu.se/nrs/index.php/om-registret). This means that nationwide data from all parts of Sweden is included in SQRP which constitutes a major strength of this database. Based on this data, an annual report is compiled by the SQRP steering group and co-workers describing and comparing the performance of the associated MMR treatment units on the overall scale. Since 2007 these accounts have been available to the public (http://www.ucr.uu.se/nrs/index.php).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 67 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chronic pain, e.g. long-term neck and back pain or progressed generalized widespread pain that has lasted more than three months
  • 18 to 67 yrs old
  • Referred to one of the specialist MMR-clinical department in Sweden

排除标准

  • Malignancies

结局指标

主要结局

Health-related quality of life (SF-36)

时间窗: Change from baseline to post-treatment, and at 12 months follow-up.

The SF-36 is a self-assessed multi-purpose, short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. It is a generic measure, as opposed to one that targets a specific age, disease, or treatment group. Accordingly, the SF-36 has proven useful in surveys of general and specific populations, comparing the relative burden of diseases, and in differentiating the health benefits produced by a wide range of different treatments.

次要结局

  • The Hospital Anxiety and Depression Scale, HAD(Change from baseline to post-treatment, and at 12 months follow-up.)
  • Multidimensional Pain Inventory (MPI)(Change from baseline to post-treatment, and at 12 months follow-up.)
  • Perceived health (EQ-5D)(Change from baseline to post-treatment, and at 12 months follow-up.)
  • Pain intensity (numeric rating scale, NRS)(Change from baseline to post-treatment, and at 12 months follow-up.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Björn O. Äng

Associate professor

Karolinska Institutet

研究点 (1)

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