Identical exercise programs with and without specific breathing techniques uncover clinically important differences on multifactorial outcome measures on chronic non-specific low back pain: A randomized feasibility trial with two-month follow-up

Abstract

Background Chronic non-specific low back pain (CNSLBP) is a leading worldwide cause of disability. Exercise is the most common conservative intervention to treat CNSLBP with modest effect sizes. Exercises with specific breathing techniques (SBTs) have potentially improved multifactorial outcomes. To our knowledge, no previous studies have been conducted to compare the outcome differences of identical exercises with or without SBTs in a uniform clinical study setting. Aims and objectives To quantify baseline demographics, self-adherence to home exercise, and monitor the usage of analgesics and other interventions, and possible adverse events. To assess the feasibility of the SBTs protocol, eligibility criteria, randomization, and dropout rates. To quantify the changes in PROMs to help determine whether progression to a full-scale trial is worthwhile and to inform the choice of the most relevant and responsive outcome measure. Design A parallel randomized analyst-blinded feasibility trial with a two-month follow-up. Methods Thirty subjects were randomized to a control group (1) with movement control exercise only (n=16) and an experimental group (2) with movement control exercises with SBTs add-on (n= 14) with a two-month follow-up. Trial registration number; NCT05268822. Results In the experimental group, which incorporated SBTs, the reduction in pain and improvement in disability from baseline to post-intervention exceeded both the minimal detectable change (MDC) and the minimal clinically important difference (MCID). Moreover, compared to the control group, the experimental group demonstrated disability improvement that exceeded the MDC and MCID. Comparable improvements were also observed in pain catastrophizing, the impact of pain on sleep, the life quality , and overall well-being. The home exercises were identical in terms of content, adherence, and progression and no adverse events were reported. Furthermore, there were very little differences between the groups in the use of analgesics or other intervention usage. The previously defined feasibility outcomes met acceptable levels. Discussion Identical exercise programs in uniform clinical settings with and without SBTs uncovered preliminary clinically important differences in multifactorial outcome measures of pain intensity, disability, catastrophizing, effect of pain on sleep, life quality, and well-being. Demographics, exercise adherence or content or contextual factors or analgesics or other intervention usage did not explain group differences. Progression to full-scale study feasibility criteria was met.