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Bracing

Scoliosis Brace for Scoliosis

N/A
Waitlist Available
Led By Ram Haddas, PhD
Research Sponsored by Texas Back Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 30- 75 years and older
Clinically diagnosed thoracolumbar and/or lumbo-sacro-pelvic deformity as defined by the SRS/Schwab classification systems as Cobb angle of 25° or greater
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline; 45 minutes and 2 moths after bracing
Awards & highlights

Study Summary

Degenerative adult scoliosis (ADS) results from age related changes leading to segmental instability, deformity and stenosis. Patients with scoliosis demonstrate an altered gait pattern.Furthermore, scoliosis patients exert 30% more physical effort than healthy subjects to ensure habitual locomotion, and this additional effort requires a reciprocal increase of oxygen consumption. Bracing has been found to reduce pain within a short time in ADS patients. A new brace has recently become available, the Peak™ Scoliosis Brace (Aspen Medical Products), designed to alleviate pain in adult patients with chronic pain secondary to scoliosis. The purpose of this study is to investigate the impact of spinal bracing using Peak™ Scoliosis Brace on pain and lower extremities kinematics of gait.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline; 45 minutes and 2 moths after bracing
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; 45 minutes and 2 moths after bracing for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Kinematic Variables Change assessed with human motion capture system
Secondary outcome measures
Patient Self-Reported Outcome Assessments Change - Fear Avoidance Beliefs Questionnaire (FABQ)
Patient Self-Reported Outcome Assessments Change - Oswestry Disability Index (ODI, version 2.1.a).
Patient Self-Reported Outcome Assessments Change - Scoliosis Research Society (SRS22)
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Scoliosis BraceExperimental Treatment1 Intervention
The Peak Scoliosis Brace designed to alleviate pain in adult patients with chronic pain secondary to scoliosis.

Find a Location

Who is running the clinical trial?

Texas Back InstituteLead Sponsor
6 Previous Clinical Trials
535 Total Patients Enrolled
Aspen Medical ProductsOTHER
5 Previous Clinical Trials
213 Total Patients Enrolled
1 Trials studying Scoliosis
20 Patients Enrolled for Scoliosis
Ram Haddas, PhDPrincipal InvestigatorTexas Back Institute
2 Previous Clinical Trials
200 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Minnesota
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

Would love to have some thing to help my symptoms after all of these years.
PatientReceived 2+ prior treatments
~4 spots leftby Mar 2025