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

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. CLINICALTRIAL ISRCTN Registry 94074203; https://doi.org/10.1186/ISRCTN94074203 INTERNATIONAL REGISTERED REPORT RR2-https://doi.org/10.1186/s12891-020-3174-z

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

“…A possible explanation for the lack of effectiveness and cost-effectiveness of e-Exercise LBP might be that, in contrast to our expectations, e-Exercise LBP did not result in a change in patients’ self-management behavior when compared with face-to-face physiotherapy. This is in line with our short-term results [ 29 ], and several explanations for this observation are possible. Even though integrating an app within face-to-face physiotherapy did result in substantially better self-reported adherence at the 3-month follow-up, the content of the app (ie, self-management information, integrated fortnightly reminders, and the continuing availability of the app) may have been insufficient to further support patients’ self-management behavior in the home setting.…”

“…From a clinical perspective, the results of this study for the primary and secondary clinical outcomes are in line with the short-term results of the e-Exercise LBP study [ 29 ] and complement the findings of previous systematic reviews of RCTs on the added value of integrating web-based applications into the treatment of patients with LBP [ 23 , 25 , 26 , 65 ]. Possible explanations for the lack of short-term effectiveness (eg, the relatively large proportion of patients with a low risk of developing persistent LBP included in the analysis who have a favorable natural prognosis and the fact that blended care is not suitable for all patients) also apply to the findings of this study and have been discussed in detail previously [ 29 ]. In general, the selected contrast between the 2 studied interventions (ie, the same content delivered either face-to-face or stratified and blended) could be too small and, therefore, hamper a clear conclusion about the effectiveness of e-Exercise LBP [ 66 , 67 ].…”

“…Secondary clinical outcomes included average LBP intensity in the last week measured using an 11-point numeric rating scale [ 32 , 38 ], mean number of minutes per day spent in moderate to vigorous physical activity objectively measured using the Activ8 accelerometer (2M Engineering) [ 39 ], fear avoidance beliefs about physical activity and work measured using the Fear-Avoidance Beliefs Questionnaire [ 40 ], pain catastrophizing measured using the Pain Catastrophizing Scale [ 41 ], self-efficacy measured using the General Self-Efficacy Scale [ 42 , 43 ], self-management ability assessed using the Dutch version of the short-form Patient Activation Measure [ 44 ], and patient self-reported adherence to prescribed home exercises measured using the Exercise Adherence Rating Scale [ 45 ]. A detailed description of the secondary clinical outcome measures can be found elsewhere [ 28 , 29 ].…”

“…In the second sensitivity analysis, absenteeism costs were estimated using the human capital approach assuming that productivity losses are generated for the entire duration of absence. In the third sensitivity analysis, the analysis was performed per risk group for developing persistent LBP (low, medium, and high) separately as this proved to be an effect modifier of the between-group differences between stratified blended physiotherapy and face-to-face physiotherapy in the short term [ 29 ].…”

“…In the short term (ie, after 3 months), e-Exercise LBP was not more effective than face-to-face physiotherapy in patients with nonspecific LBP in terms of physical functioning. However, patient self-reported adherence was substantially better among patients receiving e-Exercise LBP than among those receiving face-to-face physiotherapy only [ 29 ]. Therefore, we hypothesized that, in the long term (ie, over 12 months), the stratified blended physiotherapy group patients would have improved self-management and adherence to prescribed LBP management strategies.…”