Background Postural balance is compromised in people with low back pain, possibly by changes in motor control of the trunk. Augmenting exercising interventions with sensor-based feedback on trunk posture and movements might improve postural balance in people with low back pain. Objective We hypothesized that exercising with feedback on trunk movements reduces sway in anterior-posterior direction during quiet standing in people with low back pain. Secondary outcomes were lumbar spine and hip movement assessed during box lift and waiter bow tasks, as well as participant-reported outcomes. Adherence to the exercising intervention was also examined. Methods A randomized controlled trial was conducted with the intervention group receiving unsupervised home exercises with visual feedback using the Valedo Home, an exergame based on 2 inertial measurement units. The control group received no intervention. Outcomes were recorded by blinded staff during 4 visits (T1-T4) at University Hospital Zurich. The intervention group performed 9 sessions of 20 minutes in the 3 weeks between T2 and T3 and were instructed to exercise at their own convenience between T3 and T4. Postural balance was assessed on a force platform. Lumbar spine and hip angles were obtained from 3 inertial measurement units. The assessments included pain intensity, disability, quality of life, and fear of movement questionnaires. Results A total of 32 participants with nonspecific low back pain completed the first assessment T1, and 27 (84%) participants were randomized at T2 (n=14, 52% control and n=13, 48% intervention). Intention-to-treat analysis revealed no significant difference in change in anterior-posterior sway direction during the intervention period with a specified schedule (T2-T3) between the groups (W=99; P=.36; r=0.07). None of the outcomes showed significant change in accordance with our hypotheses. The intervention group completed a median of 61% (55/90; range 2%-99%) of the exercises in the predefined training program. Adherence was higher in the first intervention period with a specified schedule. Conclusions The intervention had no significant effect on postural balance or other outcomes, but the wide range of adherence and a limited sample size challenged the robustness of these conclusions. Future work should increase focus on improving adherence to digital interventions. Trial Registration ClinicalTrials.gov NCT04364243; https://clinicaltrials.gov/ct2/show/NCT04364243 International Registered Report Identifier (IRRID) RR2-10.2196/26982

Background Physical exercise is a common treatment for people with low back pain (LBP). Wearable sensors that provide feedback on body movements and posture during exercise may enhance postural balance and motor control in people with LBP. Objective This study aims to investigate whether physical exercising with postural feedback (EPF) improves postural balance, motor control, and patient-reported outcomes in people with LBP. Methods The study was an assessor-blinded 2×2 factorial trial. We planned to recruit 80 participants with nonspecific LBP who did not receive treatment for LBP. In addition, we aimed to recruit 40 patients with chronic, nonspecific LBP who were receiving exercise therapy (ET) at the University Hospital Zurich. Both ET patients and participants without treatment were randomized to receive either an additional EPF intervention or no additional intervention. This resulted in four different combinations of interventions: ET+EPF, ET, EPF, and no intervention. The participants underwent outcome assessments at inclusion (T1); 3 weeks later, at randomization (T2); after an intervention period of 3 weeks with a predefined exercise schedule for participants receiving EPF (T3); and after an additional 6 weeks, during which participants assigned to the EPF groups could exercise as much as they wished (T4). Patients receiving ET completed their regularly prescribed therapies during the study period. Balance was assessed during quiet standing on a force platform, and motor control was assessed during a lifting task and a waiter’s bow task. Physical activity was recorded using an activity tracker and the participants’ mobile phones during the study. The predefined EPF schedule consisted of nine sessions of 20 minutes of exercise with a tablet and inertial measurement unit sensors at home. Participants performed a series of trunk and hip movements and received feedback on their movements in a gamified environment displayed on the tablet. Results The first participant was recruited in May 2019. Data collection was completed in October 2020, with 3 patients and 32 eligible people without therapy who passed the eligibility check. Conclusions Although it will not be possible to investigate differences in patients and people without other therapies, we expect this pilot study to provide insights into the potential of EPF to improve balance in people with LBP and adherence to such interventions. International Registered Report Identifier (IRRID) DERR1-10.2196/26982

BACKGROUND Physical exercise is the most promising route to improvement for people with low back pain. Wearable sensors providing feedback on body movements and posture while exercising may enhance postural balance and motor control in people with low back pain. OBJECTIVE We aim to investigate whether physical exercising combined with postural feedback (EPF) improves postural balance, motor control, and patient reported outcomes in people with LBP. METHODS The study was a 2x2 factorial, assessor blinded trial. We planned to recruit 80 participants with unspecific low back pain, not receiving treatment for low back pain. In addition, we aimed to recruit 40 patients with chronic, unspecific low back pain in exercise therapy (ET) at the University Hospital Zurich. Both, patients in ET and participants without treatment were randomized to receive either an additional EPF intervention or no additional intervention. This resulted in 4 different combinations of interventions, ET + EPF, ET, EPF and no intervention. The participants underwent outcome assessments at inclusion (T1), 3 weeks later at randomization (T2), after an intervention period of 3 weeks with a predefined exercising schedule for participants receiving EPF (T3) and after additional 6 weeks, during which participants assigned to the EPF groups could exercise as much as they wished (T4). Patients receiving ET completed their regularly prescribed therapies during the study. Balance was assessed during quiet standing on a force platform and motor control during a lifting and a waiter’s bow task. Physical activity was recorded with an activity tracker and the participants’ mobile phone during the study. The predefined EPF schedule consisted of 9 sessions of 20 minutes exercising with a tablet and IMU sensors at home. Participants performed a series of trunk and hip movements and received feedback on their movements in a gamified environment displayed on the tablet. RESULTS The first participant was included in May 2019. Data collection was closed in October 2020 with 3 patients and 32 eligible people without therapy who passed the eligibility check. CONCLUSIONS Although it will not be possible to investigate differences in patients and people without other therapies, we expect this pilot study to give insights in the potential of exercising with postural feedback for improving balance in people with low back pain and adherence to such interventions. CLINICALTRIAL ClinicalTrials.gov NCT04364243 https://www.clinicaltrials.gov/ct2/show/NCT04364243