The effect of changing movement and posture using motion-sensor biofeedback, versus guidelines-based care, on the clinical outcomes of people with sub-acute or chronic low back pain-a multicentre, cluster-randomised, placebo-controlled, pilot trial

Abstract

BackgroundThe aims of this pilot trial were to (i) test the hypothesis that modifying patterns of painful lumbo-pelvic movement using motion-sensor biofeedback in people with low back pain would lead to reduced pain and activity limitation compared with guidelines-based care, and (ii) facilitate sample size calculations for a fully powered trial.MethodsA multicentre (8 clinics), cluster-randomised, placebo-controlled pilot trial compared two groups of patients seeking medical or physiotherapy primary care for sub-acute and chronic back pain. It was powered for longitudinal analysis, but not for adjusted single-time point comparisons. The intervention group (n = 58) received modification of movement patterns augmented by motion-sensor movement biofeedback (ViMove, dorsaVi.com) plus guidelines-based medical or physiotherapy care. The control group (n = 54) received a placebo (wearing the motion-sensors without biofeedback) plus guidelines-based medical or physiotherapy care.Primary outcomes were self-reported pain intensity (VAS) and activity limitation (Roland Morris Disability Questionnaire (RMDQ), Patient Specific Functional Scale (PSFS)), all on 0–100 scales. Both groups received 6–8 treatment sessions. Outcomes were measured seven times during 10-weeks of treatment and at 12, 26 and 52 week follow-up, with 17.0 % dropout. Patients were not informed of group allocation or the study hypothesis.ResultsAcross one-year, there were significant between-group differences favouring the intervention group [generalized linear model coefficient (95 % CI): group effect RMDQ −7.1 (95 % CI–12.6;–1.6), PSFS −10.3 (−16.6; −3.9), QVAS −7.7 (−13.0; −2.4); and group by time effect differences (per 100 days) RMDQ −3.5 (−5.2; −2.2), PSFS −4.7 (−7.0; −2.5), QVAS −4.8 (−6.1; −3.5)], all p < 0.001. Risk ratios between groups of probability of improving by >30 % at 12-months = RMDQ 2.4 (95 % CI 1.5; 4.1), PSFS 2.5 (1.5; 4.0), QVAS 3.3 (1.8; 5.9).The only device-related side-effects involved transient skin irritation from tape used to mount motion sensors.ConclusionsIndividualised movement retraining using motion-sensor biofeedback resulted in significant and sustained improvements in pain and activity limitation that persisted after treatment finished. This pilot trial also refined the procedures and sample size requirements for a fully powered RCT.This trial (Australian New Zealand Clinical Trials Registry NCT01572779) was equally funded by dorsaVi P/L and the Victorian State Government.

Better targeting care for individuals with low back pain: opportunities and obstacles

“…Subgrouping approaches based on identifying common clinical features, usually within a single dimension (ie, pain characteristics, movement patterns, psychological profiles), have also been proposed as a way to target care 5 . Individualised care goes one step further with each person, as opposed to groups of people, receiving personally tailored care 1 3 4. However, what does individualised care actually mean?…”

“…In conclusion, while some promising data3 4 suggests that individualised care for LBP might enhance the typically modest outcomes observed in LBP trials,8 these trials have all had some methodological shortcomings, requiring further investigation to better understand the potentials and limitations of individualised care. This knowledge is critical in order to train a healthcare work force to both optimise and rationalise care for people with LBP, as well as other complex, costly musculoskeletal disorders.…”

Stablebelt: Wearables in Core Stabilization

“…They were brought to my attention by scientific papers published recently (Costa et al, 2013;Kent, et al, 2015;Hügli et al, 2015). All three products make very different uses of feedback during exercises and provide compelling solutions to rehabilitation and treatment of low back pain.…”

“…Extensive information on the products available at their web sites: Riablo, Italy DorsaVi has a product called ViMove that is specifically designed to assist in assessment of low back pain (Kent, et al, 2015). It has the capability to synchronize data gathered from sensors with video for analysis.…”

“…The three products do not describe details of their implementation or of the exercises. Research papers related to research on these products usage have only been published recently (Costa, et al, 2013;Kent, et al, 2015;Hügli et al 2015). The products represented in these papers have been available on the market for a few years.…”