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Long-term Multidisciplinary Team-based Management of Back Pain (TeamBack)

2022年4月22日 更新者:Spine Centre of Southern Denmark

Long-term Multidisciplinary Team-based Management of Back Pain: Development and Feasibility (TeamBack Trial)

Long-term approaches are challenging to implement within the current care system, which rewards clinicians for attempting to quick-fix a long-term condition. This results in increased inappropriate imaging, opioid prescriptions, surgery, and visits/rehabilitation in secondary care, leading to higher societal costs and the continuing increase of LBP-related disability that is currently observed.

The investigators argue that LBP management can be optimized by providing patients with self-management strategies supported by a multidisciplinary team and providing simple, safe, and low-cost interventions that adhere to clinical guidelines. This has the potential to change patient behaviors and facilitate empowerment to self-manage LBP leading to lower societal costs of LBP.

Research objectives

The investigators will develop and test a long-term supportive multidisciplinary team-based management strategy with a specific focus on communicating a structured and unchanging message about individualized diagnosis, treatment, and prognosis, focusing on conducting a large randomized controlled trial as the next phase.

This feasibility trial will be completed in a secondary care settings, where relevant patients with poor management skills and insufficient effects of usual (primary) care management can be identified.

The specific objectives are:

(I) To develop a long-term supportive multidisciplinary team-based management strategy for secondary-care low back pain patients

(II) To test the feasibility by assessing:

  • Changes in relevant outcomes
  • Utilization of Primary care
  • Patients and clinicians experience with the intervention
  • Practical challenges of the setting

The management strategy development follows the principles provided by the Medical Research Council for developing complex interventions.

Development of the framework

Step 1: Framework setup

The investigators constructed a basic framework for the intervention by reviewing relevant systematic reviews and clinical guidelines. The research group determined the initial management intervention. Afterward, the investigators conducted a small survey on 191 participants (11% of the total sample of patients between February and May 2021), about their interest in participating. The majority would find such an approach of interest (147(77%)). In parallel, the investigators conducted short semi-structured interviews concerning the intervention with a convenient sample of 20 patients. Seventeen provided usable data.

Step 2 - Development

Using the participants' information, the investigators re-framed the management strategy. Subsequent semi-structured focus-group interviews with a clinical panel for further modifications before testing was conducted.

Step 3 - Feasibility

The multidisciplinary team for the feasibility trial consists of two coordinators (chiropractors), two therapists (physical therapists), one medical doctor, and one nurse.

The feasibility trial aims to identify and develop the appropriate framework by:

I) Investigating the patients' experiences of the current management strategy II) Ensuring satisfactory work-relations between clinicians III) Determining the primary outcome IV) Mapping the multiple interacting components of the management strategy V) Investigating how to measure parallel use of primary care and how this could be applied in the trial evaluation VI) Estimating the workload (number of hours) of the clinicians VII) Quantifying any out-of-protocol behaviors by clinicians and patients alike VIII) Quantifying the different aspects of the intervention using the clinical records

The feasibility trial will include 25 LBP patients from the Spine Centre willing to participate in a limited three-month follow-up.

The intervention procedure is:

1) A team meeting will be held each morning where the coordinator and the feasibility team will go through the patients. This will start the initial sparring process to ensure a structured and unchanging message for the patient.

The coordinator will first assess each patient face-to-face according to ICD-10 principles and enroll eligible patients in the trial. Afterward, the therapist will evaluate the patient's current functional status and management strategy. During the three months, patients will have multiple encounters with the coordinator, the therapist, and the nurse, if needed. The therapist will provide further interventions (e.g., exercise and cognitive/behavioral therapy) to encourage self-management.

The investigators will assess the following outcomes at three months: Disability (primary), pain, self-efficacy, quality of life, LBP trajectory, workability, and work retention.

研究概览

地位

完全的

条件

研究类型

介入性

注册 (实际的)

24

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Middelfart、丹麦、5500
        • Spine Centre of Southern Denmark

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Able to speak Danish
  • Disability score > 40%
  • Duration of current episode > 3 months

Exclusion Criteria:

  • Surgical candidate due to acute radiculopathy
  • Malignant or inflammatory back pain

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Multidisciplinary
A pragmatic team-based management approach is individualized for each patient.
The team will educate the patient about low back pain and how this can be self-managed.
其他名称:
  • Long-term team-based support
The team will advice the patient to conduct relevant exercises and to stay physical active.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Disability
大体时间:Changes in mean values from baseline to 3 months
The Oswestry disability index
Changes in mean values from baseline to 3 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Casper G Nim, PhD、Spine Center of Southern Denmark, University Hospital of Southern Denmark

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年11月10日

初级完成 (实际的)

2022年4月20日

研究完成 (实际的)

2022年4月20日

研究注册日期

首次提交

2021年10月13日

首先提交符合 QC 标准的

2021年10月29日

首次发布 (实际的)

2021年11月10日

研究记录更新

最后更新发布 (实际的)

2022年4月25日

上次提交的符合 QC 标准的更新

2022年4月22日

最后验证

2022年4月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • TeamBack

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

We have no plans of sharing the individual participant data, as there is no available data for secondary analyses.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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