The Effectiveness of a Lumbopelvic Monitor and Feedback Device to Change Postural Behavior: A Feasibility Randomized Controlled Trial

Abstract

postural feedback seems promising for promoting changes in postural behavior. This feasibility trial identified adherence and follow-up rates and sample-size estimates important to the conduct of a fully powered efficacy trial. T T LEVEL OF EVIDENCE:Therapy, level 2b-.

The Distinction Between Randomized Clinical Trials (RCTs) and Preliminary Feasibility and Pilot Studies: What They Are and Are Not

“…Criteria for success should be specified a priori. Ribeiro et al 10 provide an excellent example of a preliminary study addressing feasibility issues. They tried 2 variations of a novel, untried intervention; multisite recruitment; management of the time and equipment necessary to run the intervention at multiple sites; and participant acceptability, adherence, and retention.…”

“…They established that their outcome measure was able to detect change within and difference between groups, and that at least 1 of their treatment protocols showed an effect size promising enough to indicate that it would be worthwhile developing and testing that intervention further. 10 There is some debate in the literature regarding whether or not it is appropriate to assess for treatment effect in a feasibility or pilot study, or to estimate the size and variability of differences between groups. 2,8,11 The estimation of sample size is generally considered a legitimate purpose of a pilot study 7 ; however, this should only be the case when there are no data available from previous studies to indicate the likely baseline status of, and variability among, a representative sample, and no evidence informing the minimal important difference (MID) on the most appropriate outcome measure.…”

“…8 They should focus on important practicalities such as recruitment, ability to deliver the treatment properly in the intended setting, treatment acceptability, treatment fidelity, adherence, participant retention, and completeness and adequacy of outcomes data. 10 They may include within-group treatment effects, such as effect size, but these should not be the basis of sample-size calculations unless the MID for the outcome measure is genuinely not known. 9,10 Statistical comparisons between groups are likely to be misleading due to the many potential problems arising from small samples and low power.…”

“…10 They may include within-group treatment effects, such as effect size, but these should not be the basis of sample-size calculations unless the MID for the outcome measure is genuinely not known. 9,10 Statistical comparisons between groups are likely to be misleading due to the many potential problems arising from small samples and low power. Any results from statistical comparisons between groups should be treated with great caution, and reported only with explicit reference to statistical power.…”

Effectiveness of a lumbopelvic monitor and feedback device to change postural behaviour: a protocol for the ELF cluster randomised controlled trial

“…Preliminary findings suggest that the use of postural feedback may help change postural behaviour, potentially contributing to prevention and management of NSLBP 1314 The provision of real-time postural feedback during daily activities in the workplace could help healthcare workers reduce hazardous postural behaviours 13…”