Effect of Compliance Counseling on Brace Success in Patients With Idiopathic Scoliosis

The investigators plan to enroll 300 subjects prospectively with the hypothesis that some will be lost to followup, and would like a final number of at least 125 in each group. All patients who fit the inclusion criteria and consent to participate in the study will have two temperature monitors installed inside the padding in the front of their brace. The monitors will sample temperature every hour, with room temperature and body temperature representing periods of non-use and use respectively. Each temperature monitor is programmed to record temperature sequentially, so that a longer period of time can be monitored in case the patient's appointments get postponed beyond the time capacity of only one monitor. The monitors will be downloaded into a laptop computer by an orthotist in the scoliosis clinic each visit. A short questionnaire entitled the Brace Beliefs Questionnaire, consisting of 18 questions, will be administered to all patients at the time of brace prescription.

In approximately 50% of the patients, the information would be shared on each follow-up visit with the nurses, orthotist, and physician. Patients are not going to be randomized as communication in the clinic waiting room is common among braced patients. However, by having all patients treated by a specific physician included in either the counseling group, or if treated by a different physician in the standard care group, all patients in the waiting room at a given time would be enrolled in a single arm of the study. The patient and parent will then be given the visit's wear-time information and counseled regarding compliance using this information. A standardized progress report (Brace Progress Report) will be completed by the physician or orthotist.

In the other 50% of patients, only the person downloading the loggers would be aware of wear-time and that information would not be shared with the medical staff. Those patients will not receive detailed counseling regarding the actual hours of brace wear as documented by the temperature loggers, but instead will receive routine clinical care including a discussion about the importance of compliance. Radiographs routinely obtained in the clinic will be measured by the Principle Investigator. No extra radiographs will be obtained based on the participation in this study. The curve will be classified using the criteria of Lenke. Scoliosis will be measured by the Cobb angle technique and the Risser sign charted. Curve progression will be defined as progression of greater than or equal to six degrees. Patients with progression to greater than 45 degrees, who have surgery recommended, or who undergo spinal fusion surgery will be noted.

Enrollment and follow-up, gathering data, and analysis of that prospective data from 200 subjects is estimated to take approximately 5 years. We will not disclose to the subjects that information from the temperature monitors can be used to monitor compliance because such disclosure would change the purpose of the study.

With permission of the authors (Katz, et al, 2010) we will utilize de-identified BMI and brace compliance data from the 100 patients who completed their previous study. This data will be combined with the same information obtained from patient participation in this study since both studies essentially used the same method for measuring patient brace wear compliance. The increased numbers should lend stronger evidence to the findings. A target accrual number of 300 is expected (100 with de-identified retrospective data and 200 prospective study subjects).