The 3-Month Effectiveness of a Stratified Blended Physiotherapy Intervention in Patients With Nonspecific Low Back Pain: Cluster Randomized Controlled Trial

Abstract

Background Patient education, home-based exercise therapy, and advice on returning to normal activities are established physiotherapeutic treatment options for patients with nonspecific low back pain (LBP). However, the effectiveness of physiotherapy interventions on health-related outcomes largely depends on patient self-management and adherence to exercise and physical activity recommendations. e-Exercise LBP is a recently developed stratified blended care intervention comprising a smartphone app integrated with face-to-face physiotherapy treatment. Following the promising effects of web-based applications on patients’ self-management skills and adherence to exercise and physical activity recommendations, it is hypothesized that e-Exercise LBP will improve patients’ physical functioning. Objective This study aims to investigate the short-term (3 months) effectiveness of stratified blended physiotherapy (e-Exercise LBP) on physical functioning in comparison with face-to-face physiotherapy in patients with nonspecific LBP. Methods The study design was a multicenter cluster randomized controlled trial with intention-to-treat analysis. Patients with nonspecific LBP aged ≥18 years were asked to participate in the study. The patients were treated with either stratified blended physiotherapy or face-to-face physiotherapy. Both interventions were conducted according to the Dutch physiotherapy guidelines for nonspecific LBP. Blended physiotherapy was stratified according to the patients’ risk of developing persistent LBP using the Keele STarT Back Screening Tool. The primary outcome was physical functioning (Oswestry Disability Index, range 0-100). Secondary outcomes included pain intensity, fear-avoidance beliefs, and self-reported adherence. Measurements were taken at baseline and at the 3-month follow-up. Results Both the stratified blended physiotherapy group (104/208, 50%) and the face-to-face physiotherapy group (104/208, 50%) had improved clinically relevant and statistically significant physical functioning; however, there was no statistically significant or clinically relevant between-group difference (mean difference −1.96, 95% CI −4.47 to 0.55). For the secondary outcomes, stratified blended physiotherapy showed statistically significant between-group differences in fear-avoidance beliefs and self-reported adherence. In patients with a high risk of developing persistent LBP (13/208, 6.3%), stratified blended physiotherapy showed statistically significant between-group differences in physical functioning (mean difference −16.39, 95% CI −27.98 to −4.79) and several secondary outcomes. Conclusions The stratified blended physiotherapy intervention e-Exercise LBP is not more effective than face-to-face physiotherapy in patients with nonspecific LBP in improving physical functioning in the short term. For both stratified blended physiotherapy and face-to-face physiotherapy, within-group improvements were clinically relevant. To be able to decide whether e-Exercise LBP should be implemented in daily physiotherapy practice, future research should focus on the long-term cost-effectiveness and determine which patients benefit most from stratified blended physiotherapy. Trial Registration ISRCTN Registry 94074203; https://doi.org/10.1186/ISRCTN94074203 International Registered Report Identifier (IRRID) RR2-https://doi.org/10.1186/s12891-020-3174-z

No evidence for stratified exercise therapy being cost-effective compared to usual exercise therapy in patients with knee osteoarthritis: Economic evaluation alongside cluster randomized controlled trial

“…Our inconclusive result seems to be consistent with the scarce and conflicting evidence regarding the cost-effectiveness of stratified approaches of physical therapy, with two trials 32 , 48 concluding that stratified care can be cost-effective, three trials 27 , 28 , 30 , 31 concluding that stratified care is unlikely to be a cost-effective option, and a last study 49 concluding that it might be cost-effective for only one out of three subgroups, compared to usual physical therapy. These conflicting results may be indicative for stratified care having only negligible added value to current physical therapy at best, but differences across studies in country, setting, patients groups, and stratification tool could play a role as well.…”

“…As reported elsewhere, 21 we found no added value in terms of clinical outcomes of this stratified approach compared to usual exercise therapy. 25 This result aligns with that of multiple other trials in musculoskeletal patient groups, where stratified physical therapy appeared to have no added value, 26 , 27 , 28 , 29 , 30 , 31 with only one trial demonstrating a (minimal) effect of stratified physical therapy over usual care in low back pain. 32 It could be argued, however, that despite having no added value in terms of clinical outcomes, stratified exercise therapy approaches such as ours are potentially more efficient (i.e., similar effect in less consultations).…”

The Effect of an App-Based Home Exercise Program on Self-reported Pain Intensity in Unspecific and Degenerative Back Pain: Pragmatic Open-label Randomized Controlled Trial

“…However, as discussed earlier, the overall approach of this group differs from the assessment presented here, as Sandal et al [ 29 ] studied an add-on intervention for the treatment of lower back pain. Similarly, Koppenaal et al [ 30 ] assessed the effectiveness of blended physiotherapy (digital exercise training with face-to-face physiotherapy sessions) compared with the standard of care and found no group differences in pain reduction. However, an exception to this overall finding is the group of patients at a high risk of developing persistent low back pain in which blended therapy was superior to physiotherapy in terms of average reported pain reduction [ 30 ].…”

“…Similarly, Koppenaal et al [ 30 ] assessed the effectiveness of blended physiotherapy (digital exercise training with face-to-face physiotherapy sessions) compared with the standard of care and found no group differences in pain reduction. However, an exception to this overall finding is the group of patients at a high risk of developing persistent low back pain in which blended therapy was superior to physiotherapy in terms of average reported pain reduction [ 30 ]. These results underscore, from our perspective, the advantages of decentralized and immediately available digital therapies for the treatment of back pain.…”

The effect of self‐management techniques on relevant outcomes in chronic low back pain: A systematic review and meta‐analysis

“…Seven of 15 full texts were excluded due to inclusion of participants with other diagnoses than CLBP, such as neck pain or fibromyalgia (Baumeister et al., 2021; Darnall et al., 2020; Koppenaal et al., 2022; Malfliet et al., 2018; Sander et al., 2020; Selter et al., 2018; Weymann et al., 2015). Three studies had to be excluded because patients' back pain lasted less than 3 months at the time of recruitment (del Pozo‐Cruz et al., 2012; Shebib et al., 2019; Toelle et al., 2019).…”