scholarly journals App-Delivered Self-Management Intervention Trial selfBACK for People With Low Back Pain: Protocol for Implementation and Process Evaluation

10.2196/20308 ◽  
2020 ◽  
Vol 9 (10) ◽  
pp. e20308
Author(s):  
Charlotte Diana Nørregaard Rasmussen ◽  
Malene Jagd Svendsen ◽  
Karen Wood ◽  
Barbara I Nicholl ◽  
Frances S Mair ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Low Back Pain ◽  
Back Pain ◽  
Mixed Methods ◽  
Usual Care ◽  
Process Evaluation ◽  
Controlled Trial ◽  
Self Management ◽  
Low Back ◽  
Randomized Controlled

Background Implementation and process evaluation is vital for understanding how interventions function in different settings, including if and why interventions have different effects or do not work at all. Objective This paper presents the protocol for an implementation and process evaluation embedded in a multicenter randomized controlled trial conducted in Denmark and Norway (the selfBACK project). selfBACK is a data-driven decision support system that provides participants with weekly self-management plans for low back pain. These plans are delivered through a smartphone app and tailored to individual participants by using case-based reasoning methodology. In the trial, we compare selfBACK in addition to usual care with usual care alone. Methods The aim of this study is to conduct a convergent mixed-methods implementation and process evaluation of the selfBACK app by following the reach, effectiveness, adoption, implementation, and maintenance framework. We will evaluate the process of implementing selfBACK and investigate how participants use the intervention in daily life. The evaluation will also cover the reach of the intervention, health care provider willingness to adopt it, and participant satisfaction with the intervention. We will gather quantitative measures by questionnaires and measures of data analytics on app use and perform a qualitative exploration of the implementation using semistructured interviews theoretically informed by normalization process theory. Data collection will be conducted between March 2019 and October 2020. Results The trial opened for recruitment in February 2019. This mixed-methods implementation and evaluation study is embedded in the randomized controlled trial and will be collecting data from March 2019 to October 2020; dissemination of trial results is planned thereafter. The results from the process evaluation are expected 2021-2022. Conclusions This study will provide a detailed understanding of how self-management of low back pain can be improved and how a digital health intervention can be used as an add-on to usual care to support patients to self-manage their low back pain. We will provide knowledge that can be used to explore the possibilities of extending the generic components of the selfBACK system and key drivers that could be of use in other conditions and diseases where self-management is an essential prevention or treatment strategy. Trial Registration ClinicalTrials.gov NCT03798288; https://www.clinicaltrials.gov/ct2/show/NCT03798288 International Registered Report Identifier (IRRID) DERR1-10.2196/20308

scholarly journals App-Delivered Self-Management Intervention Trial selfBACK for People With Low Back Pain: Protocol for Implementation and Process Evaluation (Preprint)

2020 ◽  
Author(s):  
Charlotte Diana Nørregaard Rasmussen ◽  
Malene Jagd Svendsen ◽  
Karen Wood ◽  
Barbara I Nicholl ◽  
Frances S Mair ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Low Back Pain ◽  
Back Pain ◽  
Mixed Methods ◽  
Usual Care ◽  
Process Evaluation ◽  
Controlled Trial ◽  
Self Management ◽  
Low Back ◽  
Randomized Controlled

BACKGROUND Implementation and process evaluation is vital for understanding how interventions function in different settings, including if and why interventions have different effects or do not work at all. OBJECTIVE This paper presents the protocol for an implementation and process evaluation embedded in a multicenter randomized controlled trial conducted in Denmark and Norway (the selfBACK project). selfBACK is a data-driven decision support system that provides participants with weekly self-management plans for low back pain. These plans are delivered through a smartphone app and tailored to individual participants by using case-based reasoning methodology. In the trial, we compare selfBACK in addition to usual care with usual care alone. METHODS The aim of this study is to conduct a convergent mixed-methods implementation and process evaluation of the selfBACK app by following the reach, effectiveness, adoption, implementation, and maintenance framework. We will evaluate the process of implementing selfBACK and investigate how participants use the intervention in daily life. The evaluation will also cover the reach of the intervention, health care provider willingness to adopt it, and participant satisfaction with the intervention. We will gather quantitative measures by questionnaires and measures of data analytics on app use and perform a qualitative exploration of the implementation using semistructured interviews theoretically informed by normalization process theory. Data collection will be conducted between March 2019 and October 2020. RESULTS The trial opened for recruitment in February 2019. This mixed-methods implementation and evaluation study is embedded in the randomized controlled trial and will be collecting data from March 2019 to October 2020; dissemination of trial results is planned thereafter. The results from the process evaluation are expected 2021-2022. CONCLUSIONS This study will provide a detailed understanding of how self-management of low back pain can be improved and how a digital health intervention can be used as an add-on to usual care to support patients to self-manage their low back pain. We will provide knowledge that can be used to explore the possibilities of extending the generic components of the selfBACK system and key drivers that could be of use in other conditions and diseases where self-management is an essential prevention or treatment strategy. CLINICALTRIAL ClinicalTrials.gov NCT03798288; https://www.clinicaltrials.gov/ct2/show/NCT03798288 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/20308

scholarly journals Efficacy Of A Multidimensional Versus Usual Care Physiotherapy On Pain And Electroencephalography (EEG) Spectrum In Chronic Nonspecific Low Back Pain: Study Protocol For A Randomized Controlled Trial

2021 ◽  
Author(s):  
Sanaz Bemani ◽  
Shohreh Noorizadeh Dehkordi ◽  
Javad Sarrafzadeh ◽  
Saeed Talebian ◽  
Reza Salehi ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Low Back Pain ◽  
Back Pain ◽  
Usual Care ◽  
Controlled Trial ◽  
Biomechanical Model ◽  
Clinical Findings ◽  
Control Group ◽  
Low Back ◽  
Randomized Controlled

Abstract Background: Non-specific chronic low back pain (NSCLBP) is a major public health and global socioeconomic burden associated with a complex interplay of biopsychosocial factors. Despite scientific signs of progress, treatment of NSCLBP often tends to stick to a biomechanical model, without targeting psychological and social factors. To enhance clinical efficacy of usual physiotherapy for NSCLBP, the development of clinical strategies is to be pursued. This study aims to assess the effectiveness of multidimensional physiotherapy based on biopsychosocial approach compared to usual care physiotherapy, on clinical findings and Electroencephalography spectrum in non-specific chronic low back pain.Methods: This study is a triple-blind, two-arm (1:1) randomized controlled trial with a 4-months follow-up. 70 NSCLBP patients will be randomly allocated to either the experimental (multidimensional physiotherapy) or the active control group (usual physiotherapy), each group will receive 6-weeks of physiotherapy. The main outcome is pain and secondary outcomes are brain function, quality of life, disability, lumbar flexion range of motion and psychosocial correlates. Assessment will be performed at baseline, post-treatment and at 1- and 4-months follow-up.Discussion: Findings may provide evidence on the effectiveness of multidimensional physiotherapy on clinical findings and brain characteristics and might provide evidence towards showing the role of brain and biopsychosocial factors on chronic pain.Trial registration: ClinicalTrials.gov Identifier: NCT04270422, Registered 17 February 2020, https://clinicaltrials.gov/ct2/show/NCT04270422?term=NCT04270422&draw=2&rank=1IRCT Identifier: IRCT20140810018754N11

scholarly journals Efficacy of a multidimensional versus usual care physiotherapy on pain and electroencephalography (EEG) spectrum in chronic nonspecific low back pain: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Sanaz Bemani ◽  
Shohreh Noorizadeh Dehkordi ◽  
Javad Sarrafzadeh ◽  
Saeed Talebian ◽  
Reza Salehi ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Low Back Pain ◽  
Back Pain ◽  
Usual Care ◽  
Chronic Low Back Pain ◽  
Controlled Trial ◽  
Clinical Findings ◽  
Low Back ◽  
Randomized Controlled

Abstract Background Non-specific chronic low back pain (NSCLBP) is a major public health and global socioeconomic burden associated with a complex interplay of biopsychosocial factors. Despite scientific signs of progress, treatment of NSCLBP often tends to stick to a biomechanical model, without targeting psychological and social factors. To enhance the clinical efficacy of usual physiotherapy for NSCLBP, the development of clinical strategies is to be pursued. This study aims to assess the effectiveness of multidimensional physiotherapy based on a biopsychosocial approach compared to usual care physiotherapy, on clinical findings and electroencephalography spectrum in non-specific chronic low back pain. Methods This study is a triple-blind, two-arm (1:1) randomized controlled trial with a 4 months follow-up. Seventy NSCLBP patients will be randomly allocated to either the experimental (multidimensional physiotherapy) or the active control group (usual physiotherapy); each group will receive 6 weeks of physiotherapy. The main outcome is pain and secondary outcomes are brain function, quality of life, disability, lumbar flexion range of motion, and psychosocial correlates. Assessment will be performed at baseline, post-treatment, and at 1 and 4 months follow-up. Discussion Findings may provide evidence on the effectiveness of multidimensional physiotherapy on clinical findings and brain characteristics and might provide evidence towards showing the role of brain and biopsychosocial factors on chronic pain. Trial registration ClinicalTrials.gov NCT04270422, Registered on 17 February 2020, IRCT Identifier: IRCT20140810018754N11

scholarly journals An App-Delivered Self-Management Program for People With Low Back Pain: Protocol for the selfBACK Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Louise Fleng Sandal ◽  
Mette Jensen Stochkendahl ◽  
Malene Jagd Svendsen ◽  
Karen Wood ◽  
Cecilie K Øverås ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Low Back Pain ◽  
Usual Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Self Management ◽  
Control Group ◽  
Low Back ◽  
Current Case ◽  
Randomized Controlled

BACKGROUND Low back pain (LBP) is prevalent across all social classes, in all age groups, and across industrialized and developing countries. From a global perspective, LBP is considered the leading cause of disability and negatively impacts everyday life and well-being. Self-management is a recommended first-line treatment, and mobile apps are a promising platform to support self-management of conditions like LBP. In the selfBACK project, we have developed a digital decision support system made available for the user via an app intended to support tailored self-management of nonspecific LBP. OBJECTIVE The trial aims to evaluate the effectiveness of using the selfBACK app to support self-management in addition to usual care (intervention group) versus usual care only (control group) in people with nonspecific LBP. METHODS This is a single-blinded, randomized controlled trial (RCT) with two parallel arms. The selfBACK app provides tailored self-management plans consisting of advice on physical activity, physical exercises, and educational content. Tailoring of plans is achieved by using case-based reasoning (CBR) methodology, which is a branch of artificial intelligence. The core of the CBR methodology is to use data about the current case (participant) along with knowledge about previous and similar cases to tailor the self-management plan to the current case. This enables a person-centered intervention based on what has and has not been successful in previous cases. Participants in the RCT are people with LBP who consulted a health care professional in primary care within the preceding 8 weeks. Participants are randomized to using the selfBACK app in addition to usual care versus usual care only. We aim to include a total of 350 participants (175 participants in each arm). Outcomes are collected at baseline, 6 weeks, and 3, 6, and 9 months. The primary end point is difference in pain-related disability between the intervention group and the control group assessed by the Roland-Morris Disability Questionnaire at 3 months. RESULTS The trial opened for recruitment in February 2019. Data collection is expected to be complete by fall 2020, and the results for the primary outcome are expected to be published in fall 2020. CONCLUSIONS This RCT will provide insights regarding the benefits of supporting tailored self-management of LBP through an app available at times convenient for the user. If successful, the intervention has the potential to become a model for the provision of tailored self-management support to people with nonspecific LBP and inform future interventions for other painful musculoskeletal conditions. CLINICALTRIAL ClinicalTrial.gov NCT03798288; https://clinicaltrials.gov/ct2/show/NCT03798288 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/14720

scholarly journals An App-Delivered Self-Management Program for People With Low Back Pain: Protocol for the selfBACK Randomized Controlled Trial

10.2196/14720 ◽  
2019 ◽  
Vol 8 (12) ◽  
pp. e14720 ◽  
Author(s):  
Louise Fleng Sandal ◽  
Mette Jensen Stochkendahl ◽  
Malene Jagd Svendsen ◽  
Karen Wood ◽  
Cecilie K Øverås ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Low Back Pain ◽  
Usual Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Self Management ◽  
Control Group ◽  
Low Back ◽  
Current Case ◽  
Randomized Controlled

Background Low back pain (LBP) is prevalent across all social classes, in all age groups, and across industrialized and developing countries. From a global perspective, LBP is considered the leading cause of disability and negatively impacts everyday life and well-being. Self-management is a recommended first-line treatment, and mobile apps are a promising platform to support self-management of conditions like LBP. In the selfBACK project, we have developed a digital decision support system made available for the user via an app intended to support tailored self-management of nonspecific LBP. Objective The trial aims to evaluate the effectiveness of using the selfBACK app to support self-management in addition to usual care (intervention group) versus usual care only (control group) in people with nonspecific LBP. Methods This is a single-blinded, randomized controlled trial (RCT) with two parallel arms. The selfBACK app provides tailored self-management plans consisting of advice on physical activity, physical exercises, and educational content. Tailoring of plans is achieved by using case-based reasoning (CBR) methodology, which is a branch of artificial intelligence. The core of the CBR methodology is to use data about the current case (participant) along with knowledge about previous and similar cases to tailor the self-management plan to the current case. This enables a person-centered intervention based on what has and has not been successful in previous cases. Participants in the RCT are people with LBP who consulted a health care professional in primary care within the preceding 8 weeks. Participants are randomized to using the selfBACK app in addition to usual care versus usual care only. We aim to include a total of 350 participants (175 participants in each arm). Outcomes are collected at baseline, 6 weeks, and 3, 6, and 9 months. The primary end point is difference in pain-related disability between the intervention group and the control group assessed by the Roland-Morris Disability Questionnaire at 3 months. Results The trial opened for recruitment in February 2019. Data collection is expected to be complete by fall 2020, and the results for the primary outcome are expected to be published in fall 2020. Conclusions This RCT will provide insights regarding the benefits of supporting tailored self-management of LBP through an app available at times convenient for the user. If successful, the intervention has the potential to become a model for the provision of tailored self-management support to people with nonspecific LBP and inform future interventions for other painful musculoskeletal conditions. Trial Registration ClinicalTrial.gov NCT03798288; https://clinicaltrials.gov/ct2/show/NCT03798288 International Registered Report Identifier (IRRID) DERR1-10.2196/14720

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