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

NCT02643290 | Completed FDA Device

• 1 other identifier: 156_2015bis
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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

Back Pain

Keywords

Adult Scoliosis; Pain Management; Orthosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Pain Relief

  At start, 4 weeks, 6 months

• Pain Relief

  At start, 4 weeks, 6 months

• Pain Relief

  At start, 4 weeks, 6 months

Study Arms (1)

Patients

OTHER

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

Interventions

Peak Scoliosis Bracing System DEVICE

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

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have significant back pain from idiopathic or degenerative scoliosis
• Idiopathic or degenerative scoliosis with Cobb angle \> 30"
• Age \> 18 years

You may not qualify if:

• Prior back surgery
• Secondary scoliosis

Sponsors & Collaborators

• Aspen Medical Products: lead

Related Publications (1)

• 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.

  PMID: 33733328 DERIVED

MeSH Terms

Conditions

Back Pain; Scoliosis; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2015
• First Posted: December 31, 2015
• Study Start: April 23, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: March 3, 2017

Record last verified: 2017-02