Effectiveness and Cost-Effectiveness of a Stratified Blended Physiotherapy Intervention Compared With Face-to-Face Physiotherapy in Patients With Nonspecific Low Back Pain: Cluster Randomized Controlled Trial

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Abstract

Background

Nonspecific low back pain (LBP) is a leading contributor to disability worldwide, and its socioeconomic burden is substantial. Self-management support is an important recommendation in clinical guidelines for the physiotherapy treatment of patients with LBP and may support cost-effective management. However, providing adequate individually tailored self-management support is difficult. The integration of web-based applications into face-to-face care (ie, blended care) seems promising to optimize tailored treatment and enhance patients’ self-management and, consequently, may reduce LBP-related costs.

Objective

We aimed to evaluate the long-term effectiveness and cost-effectiveness of stratified blended physiotherapy (e-Exercise LBP) compared with face-to-face physiotherapy in patients with nonspecific LBP.

Methods

An economic evaluation was conducted alongside a prospective, multicenter, cluster randomized controlled trial in primary care physiotherapy. Patients with nonspecific LBP were treated with either stratified blended physiotherapy (e-Exercise LBP) (n=104) or face-to-face physiotherapy (n=104). The content of both interventions was based on the Dutch physiotherapy guidelines for nonspecific LBP. Blended physiotherapy was stratified according to the patients’ risk of developing persistent LBP using the STarT Back Screening Tool. The primary clinical outcome was physical functioning (Oswestry Disability Index version 2.1a). For the economic evaluation, quality-adjusted life years (QALYs; EQ-5D-5L) and physical functioning were the primary outcomes. Secondary clinical outcomes included fear avoidance beliefs and self-reported adherence. Costs were measured from societal and health care perspectives using self-report questionnaires. Effectiveness was estimated using linear mixed models. Seemingly unrelated regression analyses were conducted to estimate total cost and effect differences for the economic evaluation.

Results

Neither clinically relevant nor statistically substantial differences were found between stratified blended physiotherapy and face-to-face physiotherapy regarding physical functioning (mean difference [MD] −1.1, 95% CI −3.9 to 1.7) and QALYs (MD 0.026, 95% CI −0.020 to 0.072) over 12 months. Regarding the secondary outcomes, fear avoidance beliefs showed a statistically significant improvement in favor of stratified blended physiotherapy (MD −4.3, 95% CI −7.3 to −1.3). Societal and health care costs were higher for stratified blended physiotherapy than for face-to-face physiotherapy, but the differences were not statistically significant (societal: €972 [US $1027], 95% CI −€1090 to €3264 [US –$1151 to $3448]; health care: €73 [US $77], 95% CI −€59 to €225 [US –$62 to $238]). Among the disaggregated cost categories, only unpaid productivity costs were significantly higher for stratified blended physiotherapy. From both perspectives, a considerable amount of money must be paid per additional QALY or 1-point improvement in physical functioning to reach a relatively low to moderate probability (ie, 0.23-0.81) of stratified blended physiotherapy being cost-effective compared with face-to-face physiotherapy.

Conclusions

The stratified blended physiotherapy intervention e-Exercise LBP is neither more effective for improving physical functioning nor more cost-effective from societal or health care perspectives compared with face-to-face physiotherapy for patients with nonspecific LBP.

Trial Registration

ISRCTN 94074203; https://www.isrctn.com/ISRCTN94074203

International Registered Report Identifier (IRRID)

RR2-10.1186/s12891-020-3174-z

Related collections

Most cited references 84

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Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L)

M. Herdman, C. Gudex, S Lloyd … (2011)

Purpose This article introduces the new 5-level EQ-5D (EQ-5D-5L) health status measure. Methods EQ-5D currently measures health using three levels of severity in five dimensions. A EuroQol Group task force was established to find ways of improving the instrument’s sensitivity and reducing ceiling effects by increasing the number of severity levels. The study was performed in the United Kingdom and Spain. Severity labels for 5 levels in each dimension were identified using response scaling. Focus groups were used to investigate the face and content validity of the new versions, including hypothetical health states generated from those versions. Results Selecting labels at approximately the 25th, 50th, and 75th centiles produced two alternative 5-level versions. Focus group work showed a slight preference for the wording ‘slight-moderate-severe’ problems, with anchors of ‘no problems’ and ‘unable to do’ in the EQ-5D functional dimensions. Similar wording was used in the Pain/Discomfort and Anxiety/Depression dimensions. Hypothetical health states were well understood though participants stressed the need for the internal coherence of health states. Conclusions A 5-level version of the EQ-5D has been developed by the EuroQol Group. Further testing is required to determine whether the new version improves sensitivity and reduces ceiling effects.

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Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016

Yuan-Pang Wang, Maheswar Satpathy, Mathilde Touvier … (2018)

Summary Background As mortality rates decline, life expectancy increases, and populations age, non-fatal outcomes of diseases and injuries are becoming a larger component of the global burden of disease. The Global Burden of Diseases, Injuries, and Risk Factors Study 2016 (GBD 2016) provides a comprehensive assessment of prevalence, incidence, and years lived with disability (YLDs) for 328 causes in 195 countries and territories from 1990 to 2016. Methods We estimated prevalence and incidence for 328 diseases and injuries and 2982 sequelae, their non-fatal consequences. We used DisMod-MR 2.1, a Bayesian meta-regression tool, as the main method of estimation, ensuring consistency between incidence, prevalence, remission, and cause of death rates for each condition. For some causes, we used alternative modelling strategies if incidence or prevalence needed to be derived from other data. YLDs were estimated as the product of prevalence and a disability weight for all mutually exclusive sequelae, corrected for comorbidity and aggregated to cause level. We updated the Socio-demographic Index (SDI), a summary indicator of income per capita, years of schooling, and total fertility rate. GBD 2016 complies with the Guidelines for Accurate and Transparent Health Estimates Reporting (GATHER). Findings Globally, low back pain, migraine, age-related and other hearing loss, iron-deficiency anaemia, and major depressive disorder were the five leading causes of YLDs in 2016, contributing 57·6 million (95% uncertainty interval [UI] 40·8–75·9 million [7·2%, 6·0–8·3]), 45·1 million (29·0–62·8 million [5·6%, 4·0–7·2]), 36·3 million (25·3–50·9 million [4·5%, 3·8–5·3]), 34·7 million (23·0–49·6 million [4·3%, 3·5–5·2]), and 34·1 million (23·5–46·0 million [4·2%, 3·2–5·3]) of total YLDs, respectively. Age-standardised rates of YLDs for all causes combined decreased between 1990 and 2016 by 2·7% (95% UI 2·3–3·1). Despite mostly stagnant age-standardised rates, the absolute number of YLDs from non-communicable diseases has been growing rapidly across all SDI quintiles, partly because of population growth, but also the ageing of populations. The largest absolute increases in total numbers of YLDs globally were between the ages of 40 and 69 years. Age-standardised YLD rates for all conditions combined were 10·4% (95% UI 9·0–11·8) higher in women than in men. Iron-deficiency anaemia, migraine, Alzheimer’s disease and other dementias, major depressive disorder, anxiety, and all musculoskeletal disorders apart from gout were the main conditions contributing to higher YLD rates in women. Men had higher age-standardised rates of substance use disorders, diabetes, cardiovascular diseases, cancers, and all injuries apart from sexual violence. Globally, we noted much less geographical variation in disability than has been documented for premature mortality. In 2016, there was a less than two times difference in age-standardised YLD rates for all causes between the location with the lowest rate (China, 9201 YLDs per 100 000, 95% UI 6862–11943) and highest rate (Yemen, 14 774 YLDs per 100 000, 11 018–19 228). Interpretation The decrease in death rates since 1990 for most causes has not been matched by a similar decline in age-standardised YLD rates. For many large causes, YLD rates have either been stagnant or have increased for some causes, such as diabetes. As populations are ageing, and the prevalence of disabling disease generally increases steeply with age, health systems will face increasing demand for services that are generally costlier than the interventions that have led to declines in mortality in childhood or for the major causes of mortality in adults. Up-to-date information about the trends of disease and how this varies between countries is essential to plan for an adequate health-system response.

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Multiple imputation using chained equations: Issues and guidance for practice

Ian R White, Patrick Royston, Angela Wood (2011)

Multiple imputation by chained equations is a flexible and practical approach to handling missing data. We describe the principles of the method and show how to impute categorical and quantitative variables, including skewed variables. We give guidance on how to specify the imputation model and how many imputations are needed. We describe the practical analysis of multiply imputed data, including model building and model checking. We stress the limitations of the method and discuss the possible pitfalls. We illustrate the ideas using a data set in mental health, giving Stata code fragments. 2010 John Wiley & Sons, Ltd.

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Author and article information

Contributors

Tjarco Koppenaal:

ORCID: https://orcid.org/0000-0002-5319-4588

Research Group Empowering Healthy BehaviourDepartment of Health Innovations and TechnologyFontys University of Applied SciencesPostbus 347Eindhoven, 5600 AHNetherlands31 653945086t.koppenaal@fontys.nl

Journal

Journal ID (nlm-ta): J Med Internet Res

Journal ID (iso-abbrev): J Med Internet Res

Journal ID (publisher-id): JMIR

Title: Journal of Medical Internet Research

Publisher: JMIR Publications (Toronto, Canada )

ISSN (Print): 1439-4456

ISSN (Electronic): 1438-8871

Publication date Collection: 2023

Publication date (Electronic): 24 November 2023

Volume: 25

Electronic Location Identifier: e43034

Affiliations

[1 ] Research Group Empowering Healthy Behaviour Department of Health Innovations and Technology Fontys University of Applied Sciences Eindhoven Netherlands

[2 ] Center for Physical Therapy Research and Innovation in Primary Care Julius Health Care Centers Utrecht Netherlands

[3 ] Physical Therapy Research, Department of Rehabilitation, Physiotherapy Science and Sport University Medical Center Utrecht Brain Center Utrecht University Utrecht Netherlands

[4 ] Department of Health Sciences, Faculty of Science VU University Amsterdam Amsterdam Public Health research institute Amsterdam Netherlands

[5 ] Department of Health Sciences, Faculty of Science VU University Amsterdam Amsterdam Movement Sciences research institute Amsterdam Amsterdam Netherlands

[6 ] Research Group Innovation of Human Movement Care Research Center Healthy and Sustainable Living HU University of Applied Sciences Utrecht Netherlands

[7 ] Department of Epidemiology and Data Science Amsterdam University Medical Centre, Location Vrije Universiteit Amsterdam Netherlands

Author notes

Corresponding Author: Tjarco Koppenaal t.koppenaal@ 123456fontys.nl

Author information

Tjarco Koppenaal https://orcid.org/0000-0002-5319-4588

Johanna M van Dongen https://orcid.org/0000-0002-1606-8742

Corelien JJ Kloek https://orcid.org/0000-0002-7426-7141

Remco M Arensman https://orcid.org/0000-0002-9462-963X

Cindy Veenhof https://orcid.org/0000-0003-0970-2896

Martijn F Pisters https://orcid.org/0000-0002-2875-1709

Raymond WJG Ostelo https://orcid.org/0000-0001-7679-7210

Article

Publisher ID: v25i1e43034

DOI: 10.2196/43034

PMC ID: 10709796

PubMed ID: 37999947

SO-VID: 854a316a-f3b6-4ff5-a2e9-3cf547b7fade

Copyright © ©Tjarco Koppenaal, Johanna M van Dongen, Corelien JJ Kloek, Remco M Arensman, Cindy Veenhof, Martijn F Pisters, Raymond WJG Ostelo. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 24.11.2023.

License:

This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in the Journal of Medical Internet Research, is properly cited. The complete bibliographic information, a link to the original publication on https://www.jmir.org/, as well as this copyright and license information must be included.

History

Date received : 28 September 2022

Date revision requested : 21 March 2023

Date revision received : 6 July 2023

Date accepted : 24 October 2023

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