Efficacy of Peak Scoliosis Brace in Pain Management For Adult Scoliosis Patients
Efficacy of Peak Scoliosis Brace in Pain Management For Adult Scoliosis Patients
Aim of the study is to evaluate a new brace that has become available, the Peak Scoliosis
 Brace (Aspen Medical Products) designed to alleviate pain for adult patients with chronic
 pain secondary to scoliosis.

 20 adults with back pain secondary to Idiopathic Scoliosis will be recruited. The sample size
 was calculated considering the data collected during the development of the brace in the US.
 Patients will be evaluated at baseline immediately before starting with the brace and after 4
 weeks and 6 months. The brace must be worn for at least 2-4 hours per day.

 At each evaluation they will be asked to fill the questionnaires, to be used as outcome
 measure of the results.
Background: Some adult scoliosis patients suffer significant back pain and risk increased
 curvature leading to postural collapse. The main approach for these patients according to the
 current literature is the surgical one, however, surgery is not without complications, is not
 appropriate for all patients and certain patients do not choose to undergo surgery. Despite
 the fact that scoliosis has been estimated to affect up to 68% of the population over 60,
 there is scant literature about conservative treatments for adult scoliosis; a case report
 and a case series demonstrated the effectiveness of scoliosis specific exercise to stop
 progression, while another study reported the effectiveness of a soft brace in reducing pain
 at short time. Custom fabricated rigid torso braces, similar to those commonly used for
 children are sometimes used in adult patients, however, the goal of these braces is to
 correct and/or sustain the sagittal plane of patients, no data have been published on the
 efficacy of these braces in relief of pain, and such braces are typically not well tolerated
 by adults. Recently a new brace has become available, the Peak Scoliosis Brace (Aspen Medical
 Products) designed to alleviate pain for adult patients with chronic pain secondary to
 scoliosis.

 Aim: to test the efficacy of the Peak Scoliosis Brace in reducing pain in adult scoliosis
 patients.

 Study design: prospective cohort study. Population: 20 adults with back pain secondary to
 Idiopathic Scoliosis. The sample size was calculated considering the data collected during
 the development of the brace in the US, and the first 2 patients fitted in Italy. Setting
 alpha at 0.05 and the power at 0.8, with a mean expected improvement of 2 point in the pain
 NRS, 16 patients would be necessary.

 Considering the possibility of 25% drop out the investigators decided to recruit 20 subjects.

 Statistical analysis: If data will be normally distributed, the investigators will use a
 paired t-test. Otherwise, non-parametric statistical tests will be applied.

 Protocol: patients will be evaluated at baseline immediately before starting with the brace
 and after 4 weeks and 6 months. The brace must be worn for at least 2-4 hours per day. At
 each evaluation they will be asked to fill the NRS, Rolland Morris Questionnaire and COMI.
Inclusion Criteria:

 -  Must have significant back pain from idiopathic or degenerative scoliosis

 -  Idiopathic or degenerative scoliosis with Cobb angle > 30"

 -  Age > 18 years

 Exclusion Criteria:

 -  Prior back surgery

 -  Secondary scoliosis