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.

Study Overview

• Status: Completed
• Conditions: Back Pain
• Intervention / Treatment: Device: Peak Scoliosis Bracing System

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patients; Adult patients with low back pain secondary to an high degree scolisis are treated by fiting with a brace 2-4 hours a day and tracked for 6 months.	Device: Peak Scoliosis Bracing System; Brace is fit to adult scoliosis patients for 2-4 hours a day and tracked for six months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Relief	Oswestry Disability Index	At start, 4 weeks, 6 months
Pain Relief	Roland Morris Disability Questionnaire	At start, 4 weeks, 6 months
Pain Relief	Numerical Rating Scale	At start, 4 weeks, 6 months

Collaborators and Investigators

• Sponsor: Aspen Medical Products

Publications and helpful links

General Publications

• Zaina F, Poggio M, Di Felice F, Donzelli S, Negrini S. Bracing adults with chronic low back pain secondary to severe scoliosis: six months results of a prospective pilot study. Eur Spine J. 2021 Oct;30(10):2962-2966. doi: 10.1007/s00586-021-06808-1. Epub 2021 Mar 17.

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2015
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: December 24, 2015
• First Submitted That Met QC Criteria: December 30, 2015
• First Posted (Estimate): December 31, 2015

Study Record Updates

• Last Update Posted (Actual): March 3, 2017
• Last Update Submitted That Met QC Criteria: February 28, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Pain Management; Orthosis; Adult Scoliosis
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: 156_2015bis

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes