Abstract
BACKGROUND: Exercise is a first-line treatment for chronic non-specific low back pain (CNSLBP). Exercise combined with specific breathing techniques have the potential to improve multifactorial outcomes. No previous studies, however, have compared outcomes between identical exercises with or without a specific breathing protocol in a uniform clinical study setting. OBJECTIVES: 1) To investigate the feasibility of combining synchronized breathing with movement control exercises and evaluate eligibility criteria, randomization procedures, and dropout rates. 2) To study the preliminary efficacy of the interventions on multifactorial outcome measures. METHODS: Thirty subjects with CNSLBP were randomized into two groups. Both groups had four contact clinic visits where they received personalized home movement control exercises to practice over two months. The experimental group included a movement control exercise intervention combined with synchronized breathing techniques. Trial registration number: NCT05268822. RESULTS: Feasibility was demonstrated by meeting the recruitment goal of 30 subjects within the pre-specified timeframe with enrolment rate of 24.8% (30/121). Synchronized breathing techniques were successfully adhered by participants. Home exercise adherence was nearly identical between the groups without any adverse events. Preliminary efficacy findings on pain intensity, disability, and self-efficacy in the experimental group exceeded the minimal clinically important difference. No such findings were observed in any outcome measures within the control group. Overall, multifactorial differences were consistent because nine out of eleven outcome measures showed greater improvements for the experimental group. CONCLUSION: The synchronized breathing with movement control exercises protocol was feasible and may be more beneficial for improving multifactorial outcomes compared to identical exercises alone. Results suggested progression to a full-scale trial.