Specifically designed control interventions can account for expectation effects in clinical trials. For the interpretation of efficacy trials of physical, psychological, and self-management interventions for people living with pain, the design, conduct, and reporting of control interventions is crucial. To establish a quality standard in the field, core recommendations are presented alongside additional considerations and a reporting checklist for control interventions.Background
Objectives
Estrogen fluctuations have been implicated in the soft tissue injury gender-bias due to the hormones effect on the viscoelastic properties. The isolated effect of estrogen on the mechanical behaviour of human tendon is unknown. The purpose of this study was to elucidate the effect of circulating levels of estrogen on the strain properties of the human Achilles tendon. Twenty females (18–35 years) who were using the pill together with 20 matched, non-pill users, participated in this study. Non-pill users were tested at the time of lowest (menstruation) and highest (ovulation) estrogen whilst pill users, who exhibited constant and attenuated estrogen levels, were tested at menstruation and two weeks later. At each test session, maximal isometric plantarflexion efforts were performed on a calf-raise apparatus whilst synchronous real-time ultrasonography of the triceps surae aponeurosis was recorded. Connective tissue length (Lo) of the triceps surae complex was measured and tendon strain was calculated by dividing aponeurosis displacement during plantarflexion by Lo. Repeated measures ANOVA revealed a significant (p < 0.05) main effect of subject group with significantly higher Achilles strain rates (16.1%) in the non-pill users compared to the pill users. Augmented Achilles tendon strain was associated with higher average estrogen levels in non-pill users. Those results suggest that higher estrogen levels diminish the joint stabilising capacity of the triceps surae musculotendinous unit and may alter the energy storage capacity of the Achilles tendon during stretch-shorten cycle activities. This may result in a higher incidence of injuries during periods of high estrogen concentration.
