Efficacy of Peak Scoliosis Brace in Pain Management For Adult Scoliosis Patients

Back Pain Clinical Trial

Official title:

Efficacy of Peak Scoliosis Brace in Pain Management For Adult Scoliosis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02643290
• Other study ID #: 156_2015bis
• Status: Completed
• Phase: N/A
• First received: December 24, 2015
• Last updated: February 28, 2017
• Start date: April 23, 2015
• Est. completion date: January 2017

Study information

• Verified date: February 2017
• Source: Aspen Medical Products
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Scoliosis

Intervention

Device:
• Peak Scoliosis Bracing System
Brace is fit to adult scoliosis patients for 2-4 hours a day and tracked for six months.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aspen Medical Products

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Relief	Change in pain from baseline will be measured by means of the Core Outcome Measures Index	At start, 4 weeks, 6 months
Secondary	Pain Relief	Oswestry Disability Index	At start, 4 weeks, 6 months
Secondary	Pain Relief	Roland Morris Disability Questionnaire	At start, 4 weeks, 6 months
Secondary	Pain Relief	Numerical Rating Scale	At start, 4 weeks, 6 months