Study design: Prospective study using a specifically developed microelectronic technology.
Objective: To establish new technical methods for the objective measurement of brace use without patient involvement.
Summary of background data: Effectiveness of spinal bracing clearly depends on the compliance of the patient. For further improvement of spinal bracing, reliable data are needed concerning the brace use. Questionnaires or clinical judgment usually estimates subjectively the compliance, which ranges from 20% to 90%. So far, only 1 study with 10 patients has investigated the compliance by objective time-stamped logging in a daily life environment, showing an average brace use of 65%.
Methods: There were 9 female patients (age 14.2 years, standard deviation 1.5) with adolescent idiopathic scoliosis who took part in the study. Their thoracolumbosacral orthoses (Chêneau braces OT-Kiel, Kiel, Germany) were equipped with a specifically developed discrete data logger to record temperature at the skin-brace interface over a period of 5.4 weeks (standard deviation 3.1), at 2-minute date/time-stamped intervals.
Results: Brace use ranged from 4.2 to 22.4 hours per day (average 15.4 hours). Underlying the recommended bracing time of 23 hours, average compliance rate was 67.5% (range 19.0% to 97.1%). No patient reached a complete 23-hour bracing. Patients with poor compliance usually removed the brace during the daytime. The individual bracing pattern did not change over the course of an evaluation period, and the compliance can be estimated after 2 weeks.
Conclusions: Long-term logging of temperature within a spinal orthosis is a reliable and simple way to measure objectively the compliance. Thus, comparison of full-time and part-time bracing is made possible on an objective basis. Furthermore, knowing the bracing pattern provides a better focus on other variables of spinal bracing, such as the force distribution within the brace. This knowledge may help to improve further the shape and effectiveness of bracing.