title: 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: BACKGROUND
  The 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.
  
  
  METHODS
  A 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.
  
  
  RESULTS
  Across 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.
  
  
  CONCLUSIONS
  Individualised 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.
authors.affiliation: Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, Campusvej 55, Odense, M, 5230, Denmark. pkent@health.sdu.dk.|Research Department, Spine Centre of Southern Denmark, Hospital Lillebaelt, Institute of Regional Health Services Research, University of Southern Denmark, Middelfart, Denmark. pkent@health.sdu.dk.
authors.forename: Peter
authors.initials: P
authors.lastname: Kent
authors.affiliation: Department of Physiotherapy, Monash University, Frankston, Victoria, Australia. rob.laird@optusnet.com.au.
authors.forename: Robert
authors.initials: R
authors.lastname: Laird
authors.affiliation: Department of Physiotherapy, Monash University, Frankston, Victoria, Australia. terrence.haines@monash.edu.|Allied Health Research Unit, Monash Health, Clayton, Victoria, Australia. terrence.haines@monash.edu.
authors.forename: Terry
authors.initials: T
authors.lastname: Haines
mesh_terms: D000203:Activities of Daily Living; D000328:Adult; D000700:Analgesics / Q000627:therapeutic use; D001676:Biofeedback, Psychology / Q000295:instrumentation*; D001696:Biomechanical Phenomena; D059350:Chronic Pain / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D003131:Combined Modality Therapy; D004185:Disability Evaluation; D004867:Equipment Design; D005260:Female; D006801:Humans; D016014:Linear Models; D017116:Low Back Pain / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D008159:Lumbar Vertebrae / Q000503:physiopathology*; D008297:Male; D008875:Middle Aged; D009068:Movement; D016017:Odds Ratio; D010147:Pain Measurement; D026741:Physical Therapy Modalities / Q000592:standards; D010865:Pilot Projects; D011187:Posture; D020127:Recovery of Function; D013997:Time Factors; D014159:Transducers; D016896:Treatment Outcome; D014739:Victoria; D059015:Wireless Technology
chemical_list: D000700:Analgesics