Abstract
BackgroundMyofascial (self-)treatments, such as foam rollers to therapeutic instruments in manual therapy, are utilized increasingly in prevention and therapy in healthy people, athletes, and patients suffering from chronic back pain. However, there is limited knowledge about the effectiveness of treatment and the underlying mechanisms of myofascial therapies, especially for instrument-assisted manual therapy (IAMT). Therefore, this pilot study will investigate the feasibility and impact of IAMT for the lumbar area compared with heat application and placebo treatment as a basis for calculating the sample size for further full studies. The primary outcomes will be a critical analysis of the feasibility of the measurement protocol in terms of time economy and expressiveness and of the short- and long-term effects on shear motion of the single tissue layers of the lower back obtained through ultrasound imaging. Secondary outcomes will include thickness and compressibility of the lumbar structures and flexibility of the dorsal structures, indentometry, and superficial skin temperature.MethodsA minimum of 60 healthy, competitive 15–35-year-old female soccer players will be recruited and randomised into three groups. Short-term effects of IAMT on thoracolumbar structures will be compared with heat application and pressure-less placebo treatment. Long-term effects in the IAMT group will be tested after nine further interventions over a 5-week period (2×/week) and compared with the placebo group, which will not receive further treatments but will serve as a control. Intermediate and final testing of both groups will occur in weeks three and five.DiscussionThis pilot study will assess the feasibility and the impact of IAMT for the lower back particularly by examining the structural and functional properties of myofascial tissue using diagnostic ultrasound. These outcomes could evaluate the feasibility of the measurements used, shall build a basis for sample size calculation of further full studies, and might generate a greater understanding of myofascial therapies, especially IAMT, for the lower back and its benefits. If this approach proves to be practicable, next steps will be further full studies with soccer players, other sports, and patients with low back pain.Trial registrationGerman Clinical Trials Register (DRKS00012252) 20.06.2018; retrospectively registered.
Highlights
Myofascialtreatments, such as foam rollers to therapeutic instruments in manual therapy, are utilized increasingly in prevention and therapy in healthy people, athletes, and patients suffering from chronic back pain
(2020) 6:47 (Continued from previous page). This pilot study will assess the feasibility and the impact of instrument-assisted manual therapy (IAMT) for the lower back by examining the structural and functional properties of myofascial tissue using diagnostic ultrasound. These outcomes could evaluate the feasibility of the measurements used, shall build a basis for sample size calculation of further full studies, and might generate a greater understanding of myofascial therapies, especially IAMT, for the lower back and its benefits
The primary aims will be to evaluate the measurement methods used in terms of time economy and expressiveness and to create a basis to justify the sample size of future full studies
Summary
Study design This randomised placebo-controlled pilot study will evaluate the feasibility of the planned measurements and generate the first information about the underlying effects of IAMT on structural and functional tissue properties of the lower back as recently reported in a preexisting study on the lower leg [32]. Main outcomes like shear motion (distance in mm) and flexibility (range of motion in degree) will be analysed for the three measurement time points in the short-term evaluation as well as for all measurement time points of the IAMT group and the control group in the long-term evaluation by using a longitudinal generalised linear mixed model Those analyses will include groups, time (measurement time points), and group by time interaction as fixed effects, each participant as random effect, and a covariance structure that provided the best fit for the model to obtain estimates of slopes before and after the treatment and compared between groups like age, experiences in myofascial self-treatments, and “preferred free leg”. The Kruskal-Wallis test will be used to compare the experts ranking of suitability of the measuring instruments, whereas the time economy of the measurement
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