The feasibility and impact of instrument-assisted manual therapy (IAMT) for the lower back on the structural and functional properties of the lumbar area in female soccer players: a randomised, placebo-controlled pilot study design.

Background: Myofascial (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. Methods: A 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 (2x/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. Discussion: This 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 registration: German Clinical Trials Register (DRKS00012252) 20.06.2018; retrospectively registered.