Overview

This trial is active, not recruiting.

Condition management of pain using a brace among adult scoliosis patients
Treatment peak scoliosis bracing system
Sponsor Aspen Medical Products
Start date April 2015
End date February 2016
Trial size 20 participants
Trial identifier NCT02643290, 156_2015bis

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Adult patients with significant scoliosis pain are fit with a brace and tracked for 6 months.
peak scoliosis bracing system
Brace is fit to adult scoliosis patients and tracked for six months.

Primary Outcomes

Measure
Pain Relief
time frame: At start, 4 weeks, 6 months

Secondary Outcomes

Measure
Pain Relief
time frame: At start, 4 weeks, 6 months
Pain Relief
time frame: At start, 4 weeks, 6 months
Pain Relief
time frame: At start, 4 weeks, 6 months

Eligibility Criteria

Male or female participants at least 40 years old.

Inclusion Criteria: - Must have significant back pain from non idiopathic scoliosis - Idiopathic scoliosis sith Cobb angle > 30" - Age > 18 years Exclusion Criteria: - Prior back surgery - Secondary scoliosis

Additional Information

Official title Efficacy of Peak Scoliosis Brace in Pain Management For Adult Scoliosis Patients
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Aspen Medical Products.