All three authors were paid from the funding provided by the Victorian State Government and dorsaVi, a market-rate consulting fee for participating in various phases of the study: PK, RL, TH - project design, RL - data collection, TH - data analysis. The authors analysed the results and wrote the manuscript independently of both funders, and neither funder had any influence over how these data were presented and the conclusions reached.
PK and TH have no other financial links, directly or indirectly, with dorsaVi, except PK received a market-rate consulting fee for assistance in designing a subsequent RCT protocol based on the results of this pilot trial.
RL has received a market-rate consulting fee for participating in other clinical and research aspects of dorsaVi’s product development, and has been reimbursed for travel/conference expenses related to the dorsaVi motion-sensor technology. He has no other financial links, directly or indirectly, with dorsaVi.
The participating clinicians were paid a market rate fee to reimburse them for their time consulting patients. All patients received up to 40 Australian dollars to reimburse them for their parking and travel expenses, and to assist with courier return of the ViMove device.
All authors contributed to the study design, analysis and interpretation of the data, drafting of the manuscript and approved the final version of the paper. PK wrote the initial draft of the manuscript, TH performed most statistical analysis, and RL trained the participating clinicians and participated in data collection.
PK takes responsibility for the writing, TH for the data analysis and all three authors for the interpretation.
Clinicians: Ms Leanne Scown, Mr Jayce Gilbert, Mr Rob Laird and Dr Steve de Graaff, Dr Joe Garra, Dr Steve Jensen, Dr Adrian Jurey, Dr David Vivian and Dr Peter Braun.
Trial Steering and Data Monitoring Committee (independent members): Dr Anne Daly, Dr Catherine Said, Dr John Fergusson
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.
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.
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.
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.
Vos T, Flaxman AD, Naghavi M, Lozano R, Michaud C, Ezzati M, et al. Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990–2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012;380(9859):2163–96. doi:10.1016/s0140-6736(12)61729-2. PubMedCrossRef
Spengler DM, David DP. Industrial low back pain: A practical approach. In: Wiesel SW, editor. Industrial low back pain: A comprehensive approach. Charlottesville, VA, USA: The Michie Company; 1985. p. 869–71.
Hayden JA, van Tulder MW, Malmivaara A, Koes BW. Exercise therapy for treatment of non-specific low back pain. Cochrane Database Syst Rev. 2005;3, CD000335. doi:10.1002/14651858.CD000335.pub2. PubMed
Walker BF, French SD, Grant W, Green S. Combined chiropractic interventions for low-back pain. Cochrane Database Syst Rev. 2010;4, CD005427. doi:10.1002/14651858.CD005427.pub2. PubMed
Hill JC, Whitehurst DG, Lewis M, Bryan S, Dunn K, Foster NE, et al. Comparison of stratified primary care management for low back pain with current best practice (STarT Back): a randomised controlled trial. Lancet. 2011;378(9802):1560–71. doi:10.1016/S0140-6736(11)60937-9.. PubMedPubMedCentralCrossRef
Van Dillen LR, Sahrmann SA, Norton BJ, Caldwell CA, McDonnell MK, Bloom N. The effect of modifying patient-preferred spinal movement and alignment during symptom testing in patients with low back pain: A preliminary report. Arch Phys Med Rehabil. 2003;84(3 Suppl 1):22–313.
Vibe Fersum K, O’Sullivan P, Skouen JS, Smith A, Kvåle A. Efficacy of classification-based cognitive functional therapy in patients with non-specific chronic low back pain: A randomized controlled trial. Eur J Pain. 2012;17(6):916–28. doi:10.1002/j.1532-2149.2012.00252.x. PubMedPubMedCentralCrossRef
Van Daele U, Hagman F, Truijen S, Vorlat P, Van Gheluwe B, Vaes P. Decrease in postural sway and trunk stiffness during cognitive dual-task in nonspecific chronic low back pain patients, performance compared to healthy control subjects. Spine. 2010;35(5):583–9. doi:10.1097/BRS.0b013e3181b4fe4d. PubMedCrossRef
Dunk NM, Callaghan JP. Lumbar spine movement patterns during prolonged sitting differentiate low back pain developers from matched asymptomatic controls. Work. 2010;35(1):3–14. doi:10.3233/wor-2010-0953. PubMed
de Jager JP, Ahern MJ. Improved evidence-based management of acute musculoskeletal pain: guidelines from the National Health and Medical Research Council are now available. Med J Aust. 2004;181(10):527–8. PubMed
Savigny P, Kuntze S, Watson P, Underwood M, Ritchie G, Cotterell M, et al. Low back pain - Early management of persistent non-specific low back pain. London: National Collaborating Centre for Primary Care and Royal College of General Practitioners; 2009.
Hodges PW, Cholewicki J. Functional control of the spine, in movement, stability & lumbopelvic pain. In: Vleeming A, Mooney V, Stoeckart R, editors. Movement, Stability & Lumbopelvic Pain - Integration of Research and Therapy. Edinburgh: Churchill Livingstone; 2007.
Bryan M, Hawson S. The benefits of Pilates exercise in orthopaedic rehabilitation. Tech Orthop. 2003;18(1):126–9. CrossRef
McKenzie R, May S. Lumbar Spine, Mechanical Diagnosis and Therapy. 2nd ed. Waikanae, New Zealand: Spinal Publications Ltd; 2003.
Richardson C, Jull G, Hodges P, Hides J. Therapeutic exercise for spinal segmental stabilization in low back pain: scientific basis and clinical approach. Edinburgh: Churchill Livingstone; 1999.
Group AAMPG. Chapter 4: Acute low back pain. Evidence-based management of acute musculoskeletal pain. Bowen Hills, Queensland: Australian Academic Press; 2003.
Ronchi AJ, Lech M, Taylor NF, Cosic I, editors. A reliability study of the new Back Strain Monitor based on clinical trials. Conf Proc IEEE Eng Med Biol Soc. 2008;2008:693-6. doi: 10.1109/IEMBS.2008.4649247.
Charry E, Umer M, Taylor S, editors. Design and validation of an ambulatory inertial system for 3-D measurements of low back movements. Proceedings of Seventh International Conference on Intelligent Sensors, Sensor Networks and Information Processing (ISSNIP 2011); 2011. IEEE Conference Publications (http://ieeexplore.ieee.org) DOI: 10.1109/ISSNIP.2011.6146618
Froud R, Eldridge S, Underwood M. Reporting methods in back pain trials. Part I: Outcome measures. Palma de Mallorca: Palma de Mallorca International Forum IX Primary Care Research On Low Back Pain; 2007.
Davidson M, Keating JL. A comparison of five low back disability questionnaires: reliability and responsiveness. Phys Ther. 2002;82(1):8–24. PubMed
Davies C, Nitz A. Psychometric properties of the Roland-Morris Disability Questionnaire ccompared to the Oswestry Disability Index: a systematic review. Phys Ther Rev. 2009;14(6):399–408. CrossRef
Abbott JH, Schmitt JS. The Patient-Specific Functional Scale was valid for group-level change comparisons and between-group discrimination. J Clin Epidemiol. 2014. doi:10.1016/j.jclinepi.2013.11.002. PubMed
Cleland JA, Fritz JM, Brennan GP. Predictive validity of initial fear avoidance beliefs in patients with low back pain receiving physical therapy: is the FABQ a useful screening tool for identifying patients at risk for a poor recovery? Eur Spine J. 2008;17(1):70–9. doi:10.1007/s00586-007-0511-y. PubMedCrossRef
Hauggaard A, Persson AL. Specific spinal stabilisation exercises in patients with low back pain - a systematic review. Phys Ther Rev. 2007;12:233–48. CrossRef
May S, Johnson R. Stabilisation exercises for low back pain: a systematic review. Physiotherapy. 2008;94:179–89. CrossRef
Ernst E, Canter PH. The Alexander technique: a systematic review of controlled clinical trials. Forschende Komplementarmedizin und klassische Naturheilkunde. Research in complementary and natural classical medicine. 2003;10(6):9–325. 75886.
Little P, Lewith G, Webley F, Evans M, Beattie A, Middleton K, et al. Randomised controlled trial of Alexander technique lessons, exercise, and massage (ATEAM) for chronic and recurrent back pain. Br J Sports Med. 2008;42(12):965–8. PubMed
Donovan JJ, Radosevich DJ. A meta-analytic review of the distribution of practice effect: Now you see it, now you don’t. J App Psychol. 1999;84(5):795–805. CrossRef
- 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
- BioMed Central
Neu im Fachgebiet Orthopädie und Unfallchirurgie
Mail Icon II