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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.

ABSTRACT: 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.

SUBMITTER: Kent P

PROVIDER: S-EPMC4446825 | biostudies-literature | 2015 May

REPOSITORIES: biostudies-literature

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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.

Kent Peter P Laird Robert R Haines Terry T

BMC musculoskeletal disorders 20150529

<h4>Background</h4>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.<h4>Methods</h4>A multicentre (8 clinics), cluster-randomised, placebo-controlled pilot trial compared two groups of patients seeking medical o ...[more]

PMID: 26022102

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Project description:IntroductionLow back pain (LBP) is the leading cause of disability globally and its costs exceed those of cancer and diabetes combined. Recent evidence suggests that individualised cognitive and movement rehabilitation combined with lifestyle advice (cognitive functional therapy (CFT)) may produce larger and more sustained effects than traditional approaches, and movement sensor biofeedback may enhance outcomes. Therefore, this three-arm randomised controlled trial (RCT) aims to compare the clinical effectiveness and economic efficiency of individualised CFT delivered with or without movement sensor biofeedback, with usual care for patients with chronic, disabling LBP.Methods and analysisPragmatic, three-arm, randomised, parallel group, superiority RCT comparing usual care (n=164) with CFT (n=164) and CFT-plus-movement-sensor-biofeedback (n=164). Inclusion criteria include: adults with a current episode of LBP >3 months; sought primary care ?6 weeks ago for this episode of LBP; average LBP intensity of ?4 (0-10 scale); at least moderate pain-related interference with work or daily activities. The CFT-only and CFT-plus-movement-sensor-biofeedback participants will receive seven treatment sessions over 12 weeks plus a 'booster' session at 26 weeks. All participants will be assessed at baseline, 3, 6, 13, 26, 40 and 52 weeks. The primary outcome is pain-related physical activity limitation (Roland Morris Disability Questionnaire). Linear mixed models will be used to assess the effect of treatment on physical activity limitation across all time points, with the primary comparison being a formal test of adjusted mean differences between groups at 13 weeks. For the economic (cost-utility) analysis, the primary outcome of clinical effect will be quality-adjusted life years measured across the 12-month follow-up using the EuroQol EQ-5D-5L .Ethics and disseminationApproved by Curtin University Human Research Ethics Committee (HRE2018-0062, 6 Feb 2018). Study findings will be disseminated through publication in peer-reviewed journals and conference presentations.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12618001396213).

Project description:The accuracy of motion prediction, utilized to overcome the system latency of motion management radiotherapy systems, is hampered by irregularities present in the patients' respiratory pattern. Audiovisual (AV) biofeedback has been shown to reduce respiratory irregularities. The aim of this study was to test the hypothesis that AV biofeedback improves the accuracy of motion prediction.An AV biofeedback system combined with real-time respiratory data acquisition and MR images were implemented in this project. One-dimensional respiratory data from (1) the abdominal wall (30 Hz) and (2) the thoracic diaphragm (5 Hz) were obtained from 15 healthy human subjects across 30 studies. The subjects were required to breathe with and without the guidance of AV biofeedback during each study. The obtained respiratory signals were then implemented in a kernel density estimation prediction algorithm. For each of the 30 studies, five different prediction times ranging from 50 to 1400 ms were tested (150 predictions performed). Prediction error was quantified as the root mean square error (RMSE); the RMSE was calculated from the difference between the real and predicted respiratory data. The statistical significance of the prediction results was determined by the Student's t-test.Prediction accuracy was considerably improved by the implementation of AV biofeedback. Of the 150 respiratory predictions performed, prediction accuracy was improved 69% (103/150) of the time for abdominal wall data, and 78% (117/150) of the time for diaphragm data. The average reduction in RMSE due to AV biofeedback over unguided respiration was 26% (p < 0.001) and 29% (p < 0.001) for abdominal wall and diaphragm respiratory motion, respectively.This study was the first to demonstrate that the reduction of respiratory irregularities due to the implementation of AV biofeedback improves prediction accuracy. This would result in increased efficiency of motion management techniques affected by system latencies used in radiotherapy.

Project description:BackgroundMovement and posture are commonly believed to relate to low back pain (LBP). Yet, we know little about how people make sense of the relationship between their LBP, movement and posture, particularly after recovery. We aimed to qualitatively explore this understanding, how it changes and how it relates to quantitative changes.MethodsA mixed method study in the context of an existing single-case design involving 12 people with disabling non-specific LBP. Interviews were conducted before and after a 12-week physiotherapy-led Cognitive Functional Therapy intervention, and qualitative findings from these were integrated with individualized, quantitative measures of movement, posture, psychological factors, pain and activity limitation.ResultsStrong beliefs about movement and posture were identified during the baseline interviews. Lived experiences of tension and stiffness characterized the embodiment of 'nonconscious protection', while healthcare and societal messages prompted pain-related fear and 'conscious protection'. Through varied journeys, most participants reported improvements over time with less protective movement and postural strategies. For some, being less protective required focused attention ('conscious non-protection'), but most returned to automatic, normal and fearless patterns ('nonconscious non-protection'), forgetting about their LBP. One participant reported no meaningful shift, remaining protective. Greater spinal range, faster movement, more relaxed postures and less back muscle EMG accompanied positive changes in self-report factors.ConclusionThe findings offer a framework for understanding how people make sense of movement and posture during the process of recovery from persistent, disabling non-specific LBP. This involved a re-conceptualisation of movement and posture, from threatening, to therapeutic.SignificanceFindings from qualitative interviews before and after a Cognitive Functional Therapy intervention in 12 people with disabling low back pain highlighted an individualized recovery journey from conscious and nonconscious protection to conscious non-protection for some, and nonconscious non-protection for many. Pre and post-quantitative measures of movement, posture, psychological factors, pain and activity limitation integrated well with the qualitative findings. The findings suggest movement and posture may form part of a multidimensional pain schema.

Project description:In lung radiotherapy, variations in cycle-to-cycle breathing results in four-dimensional computed tomography imaging artifacts, leading to inaccurate beam coverage and tumor targeting. In previous studies, the effect of audiovisual (AV) biofeedback on the external respiratory signal reproducibility has been investigated but the internal anatomy motion has not been fully studied. The aim of this study is to test the hypothesis that AV biofeedback improves diaphragm motion reproducibility of internal anatomy using magnetic resonance imaging (MRI).To test the hypothesis 15 healthy human subjects were enrolled in an ethics-approved AV biofeedback study consisting of two imaging sessions spaced ∼1 week apart. Within each session MR images were acquired under free breathing and AV biofeedback conditions. The respiratory signal to the AV biofeedback system utilized optical monitoring of an external marker placed on the abdomen. Synchronously, serial thoracic 2D MR images were obtained to measure the diaphragm motion using a fast gradient-recalled-echo MR pulse sequence in both coronal and sagittal planes. The improvement in the diaphragm motion reproducibility using the AV biofeedback system was quantified by comparing cycle-to-cycle variability in displacement, respiratory period, and baseline drift. Additionally, the variation in improvement between the two sessions was also quantified.The average root mean square error (RMSE) of diaphragm cycle-to-cycle displacement was reduced from 2.6 mm with free breathing to 1.6 mm (38% reduction) with the implementation of AV biofeedback (p-value < 0.0001). The average RMSE of the respiratory period was reduced from 1.7 s with free breathing to 0.3 s (82% reduction) with AV biofeedback (p-value < 0.0001). Additionally, the average baseline drift obtained using a linear fit was reduced from 1.6 mm∕min with free breathing to 0.9 mm∕min (44% reduction) with AV biofeedback (p-value = 0.012). The diaphragm motion reproducibility improvements with AV biofeedback were consistent with the abdominal motion reproducibility that was observed from the external marker motion variation.This study was the first to investigate the potential of AV biofeedback to improve the motion reproducibility of internal anatomy using MRI. The study demonstrated the significant improvement in diaphragm motion reproducibility using AV biofeedback combined with MRI. This system can potentially provide clinically beneficial motion management of internal anatomy in MRI and radiotherapy.

Dataset Information

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.

Publications

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.

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