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

NCT02643290 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-03-03

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Peak Scoliosis Bracing System

Brace is fit to adult scoliosis patients for 2-4 hours a day and tracked for six months.

Sponsors & Collaborators

  • Aspen Medical Products

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-23
Primary Completion
2017-01-31
Completion
2017-01-31
FDA Device
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02643290 on ClinicalTrials.gov