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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.
BMC Musculoskelet Disord. 2015 May 29; 16:131.BM

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+Show Affiliations

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.Department of Physiotherapy, Monash University, Frankston, Victoria, Australia. rob.laird@optusnet.com.au.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.

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

26022102

Citation

Kent, Peter, et al. "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." BMC Musculoskeletal Disorders, vol. 16, 2015, p. 131.
Kent P, Laird R, Haines T. 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. BMC Musculoskelet Disord. 2015;16:131.
Kent, P., Laird, R., & Haines, T. (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. BMC Musculoskeletal Disorders, 16, 131. https://doi.org/10.1186/s12891-015-0591-5
Kent P, Laird R, Haines T. 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. BMC Musculoskelet Disord. 2015 May 29;16:131. PubMed PMID: 26022102.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Kent,Peter, AU - Laird,Robert, AU - Haines,Terry, Y1 - 2015/05/29/ PY - 2014/12/08/received PY - 2015/05/18/accepted PY - 2015/5/30/entrez PY - 2015/5/30/pubmed PY - 2016/2/10/medline SP - 131 EP - 131 JF - BMC musculoskeletal disorders JO - BMC Musculoskelet Disord VL - 16 N2 - 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. SN - 1471-2474 UR - https://www.unboundmedicine.com/medline/citation/26022102/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_ L2 - https://bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-015-0591-5 DB - PRIME DP - Unbound Medicine ER -