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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02643290
First Posted: December 31, 2015
Last Update Posted: March 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Aspen Medical Products
  Purpose

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.


Condition Intervention
Back Pain Device: Peak Scoliosis Bracing System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Peak Scoliosis Brace in Pain Management For Adult Scoliosis Patients

Resource links provided by NLM:


Further study details as provided by Aspen Medical Products:

Primary Outcome Measures:
  • Pain Relief [ Time Frame: At start, 4 weeks, 6 months ]
    Change in pain from baseline will be measured by means of the Core Outcome Measures Index


Secondary Outcome Measures:
  • Pain Relief [ Time Frame: At start, 4 weeks, 6 months ]
    Oswestry Disability Index

  • Pain Relief [ Time Frame: At start, 4 weeks, 6 months ]
    Roland Morris Disability Questionnaire

  • Pain Relief [ Time Frame: At start, 4 weeks, 6 months ]
    Numerical Rating Scale


Enrollment: 20
Actual Study Start Date: April 23, 2015
Study Completion Date: January 2017
Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Aspen Medical Products
ClinicalTrials.gov Identifier: NCT02643290     History of Changes
Other Study ID Numbers: 156_2015bis
First Submitted: December 24, 2015
First Posted: December 31, 2015
Last Update Posted: March 3, 2017
Last Verified: February 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Aspen Medical Products:
Adult Scoliosis
Pain Management
Orthosis

Additional relevant MeSH terms:
Back Pain
Scoliosis
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases