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临床试验/NCT04463043
NCT04463043已完成不适用

The Effectiveness of an App-based (selfBACK) Versus a Web-based (e-Help) Self-management Intervention or Usual Care in People With Low Back and/or Neck Pain on a Waiting List for Hospital-based Outpatient Rehabilitation: a Three Arm Randomised Controlled Trial

Norwegian University of Science and Technology1 个研究点 分布在 1 个国家目标入组 294 人开始时间: 2020年7月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
294
试验地点
1
主要终点
Musculoskeletal Health Questionnaire (MSK-HQ)

研究概览

简要总结

The purpose of this study is to evaluate the effectiveness of an individually tailored self-management intervention, the selfBACK app, in improving health status in patients on a waiting list for outpatient rehabilitation due to low back and/or neck pain compared to a non-tailored web-based self-management solution (e-Help) and usual care only.

详细描述

Patients on waiting list for treatment at the multidisciplinary outpatient clinic for back, neck and shoulder rehabilitation, St. Olavs Hospital, Trondheim University Hospital, Norway, due to low back and/or neck pain are the target group for this study. The average waiting time for receiving treatment is 8-10 weeks. The use of digital solutions can be a beneficial approach to support self-management during the waiting period. Therefore, the effectiveness of these tools in this patients group needs to be evaluated.

A total of 279 participants will be recruited and randomly allocated to one of the three groups: 1) the selfBACK app in addition to usual care; 2) the e-Help webpage in addition to usual care; and 3) usual care only. Participants who receive either the selfBACK app and the e-Help webpage will be allowed to seek care, treatment or help elsewhere as usual.

Self-reported outcome measures will be collected through web-based questionnaires at three follow-up time points: 1) 6 weeks; 2) 3 months (primary endpoint); and 3) 6 months. In addition, participants receiving the selfBACK app will be asked a set of weekly tailoring questions to individualize self-management plans. Objective registry based data linked to social security number in Norway will be used to investigate health care consumption and sickness absence at 1 year (and up to 5 years).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

This study is a single-blinded trial. Participants and health personnel at the clinic will not be blinded to group allocation, whereas researchers performing the analysis and the interpretation of the results will be blinded to group allocation. Once the study is completed, the data will be extracted from the database in anonymized form for statistical analyses, i.e. all personal information that may identify specific participants or group allocation will be removed and the intervention and control groups will be randomly labelled as A, B and C.

入排标准

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

入选标准

  • •On waiting list for treatment at the multidisciplinary outpatient clinic for back, neck and shoulder rehabilitation, St. Olavs Hospital, Trondheim University Hospital, Norway due to low back pain and/or neck pain
  • •Own and use a smartphone with internet access to download the mobile application
  • •Able to provide informed consent

排除标准

  • •Less than 4 weeks waiting time until scheduled appointment at clinic (i.e., patients prioritized for urgent treatment/examination)
  • •Unable to take part in exercise/physical activity, e.g. non-ambulatory patients, use of walking aids, unable to get up and down the floor independently
  • •Unable to speak and/or read Norwegian
  • •Unable to complete the baseline questionnaire

研究组 & 干预措施

SelfBACK app

Experimental

The selfBACK app in addition to usual care

干预措施: SelfBACK app (Device)

SelfBACK app

Experimental

The selfBACK app in addition to usual care

干预措施: Usual care (Other)

e-Help webpage

Active Comparator

The e-Help webpage in addition to usual care

干预措施: e-Help webpage (Other)

e-Help webpage

Active Comparator

The e-Help webpage in addition to usual care

干预措施: Usual care (Other)

Usual care

Active Comparator

Usual care only

干预措施: Usual care (Other)

结局指标

主要结局

Musculoskeletal Health Questionnaire (MSK-HQ)

时间窗: Change from baseline to 3 months

The MSK-HQ is used to measure musculoskeletal health status. The MSK-HQ contains 14 items scored from 0 to 4. The final score ranges from 0 to 56 (sum of all items), with higher scores indicating better musculoskeletal health status.

次要结局

  • Worst pain intensity(Change from baseline to 3 months)
  • Pain-related disability for neck pain(Change from baseline to 3 months)
  • Average pain intensity(Change from baseline to 3 months)
  • Pain-related disability for low back pain(Change from baseline to 3 months)
  • Health related quality of life(Change from baseline to 3 months)
  • Pain self-efficacy(Change from baseline to 3 months)
  • Illness perception(Change from baseline to 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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