Protocol of identical exercise programs with and without specific breathing techniques for the treatment of chronic low back pain: randomized feasibility trial with two-month follow-up.

Abstract

Background Chronic low back pain (CLBP) is a leading cause of disability globally. Exercise therapies are one of the commonly prescribed treatment options for CLBP. The specific exercise therapies for CLBP most commonly target movement dysfunction, but seldom brain-based pain modulation. Exercise therapies with specific breathing techniques (SBTs) have been shown to influence and enhance brain-based structural and functional pain modulation. Aims and objectives To assess the feasibility of the SBTs protocol, eligibility criteria, randomization, and dropout rates. To quantify the changes in patient outcome measures and choose the most relevant measure for larger-scale study. To quantify self-adherence levels to home exercise and monitor and record possible pain medication and other treatment modality usage, and adverse events during exercise. Design A parallel randomised analyst-blinded feasibility trial with two-month follow-up. Outcome measures Feasibility related to aims and objectives. Multiple pain- and health-related patient-reported outcome measures of pain intensity, disability, central sensitization, anxiety, kinesiophobia, catastrophising, self-efficacy, sleep quality, quality of life, and health and well-being status. Exercise adherence, pain medication and other treatment modality usage, and possible adverse events related to exercises will be monitored and recorded. Methods Thirty participants will be randomized to movement control exercise with SBTs (experimental group) or movement control exercise without SBTs (control group) with an allocation ratio of 1:1. Discussion SBTs are a simple, free, and safe addition to exercise that may influence clinical outcomes. The clinical difference in effectiveness between practically identical exercise programs in uniform study settings with or without SBTs has not been studied before.

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

“…Enrolled participants booked eligibility assessment appointments at the rst author's clinic, where written consent for the study was given. After written consent, neurological examination of nerve root pathology and low back movement control clinical tests were performed as described by Luomajoki et al (31,32).…”

“…Subjects were blinded for intervention differences between groups. Recruitment and data collection are described in more detail in the previous protocol publication (32).…”

“…Movement control exercises were applied in both groups with or without SBTs as a monotherapy. Exercises, their clinical application, and the theoretical background of a maladaptive movement contributing to CNSLBP are described in more detail in the protocol publication of this study (32) and previous movement control clinical studies (64-67).…”

“…Detailed instructions for synchronization of the breathing cycle with the movement for each speci c movement control exercise are provided in the previously published protocol (32).…”

“…The main efforts were: (i) We monitored baseline demographic factors in detail; (ii) we included strict inclusion and exclusion criteria and throughout physical examination to include subjects with CNSLBP and movement control impairment; (iii) we attempted to exclude known cardiovascular, respiratory, rheumatic and neurological diseases potentially affecting breathing mechanics and hence potentially affecting the effects of SBTs;(iv) by using a single-clinician study design we minimized the intervention differences and effects of contextual factors; (v) we monitored exercises delivered during the study in content, adherence, and progression; (vi) we concentrated solely on movement control to exclude other evidence-based interventions to promote more precise the outcome differences between study groups; (vii) we monitored usage of analgesics and other therapies during the study. The study protocol describing study design and intervention in more detail was previously published (32). There are no previous studies that have compared the outcome of identical exercises with or without SBTs in a uniform clinical study setting to inform possible differences in multifactorial PROMs.…”