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01.12.2015 | Research article | Ausgabe 1/2015 Open Access

BMC Musculoskeletal Disorders 1/2015

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

Zeitschrift:
BMC Musculoskeletal Disorders > Ausgabe 1/2015
Autoren:
Peter Kent, Robert Laird, Terry Haines
Wichtige Hinweise

Competing interests

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.

Authors’ contributions

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.

Trial investigators

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

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.
Literatur
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