A Randomized Crossover Pilot Study To Determine Clinical Effectiveness and Patient Wellness of Inelastic Lumbosacral Orthoses Versus Standard Medical Treatment in Patients With Back Pain AssociatEd With Kyphosis (The ARISE Study)

Aspen Medical Products0 sites16 target enrollmentJune 2012

ConditionsKyphosis Back Pain

Overview

Phase: N/A
Intervention: Not specified
Conditions: Kyphosis
Sponsor: Aspen Medical Products
Enrollment: 16
Primary Endpoint: Mean difference in the Oswestry Disability Index Scores of the intervention versus control groups
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The objective of this study is to evaluate clinical effectiveness and the effect on quality of life of an inelastic thoracolumbarasacral orthosis in male and female hyperkyphotic patients with moderate to severe back pain disability and to demonstrate the safety of the intervention through detailed reporting and analysis of adverse events.

Registry

clinicaltrials.gov

Start Date

June 2012

End Date

March 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Aspen Medical Products

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients with moderate to complete disability (crippled) as defined by a score of 21% to 80% on the baseline evaluation of the Oswestry Back Pain Disability Questionnaire;
•Patients diagnosed with kyphosis and have a Cobb angle of at least 55 degrees;
•Willing and able to comply with the study procedures and provide written informed consent to participate in the study.

Exclusion Criteria

•Patients under the age of 19;
•Pregnant patients or patients who are considering future pregnancies;
•Patients who were participating in any other investigational device or drug study or whose participation in a previous investigational study within 30 days of study entry may, in the opinion of the clinical investigator, impact analysis of this orthotic;
•Patients who, in the clinical judgment of the investigator, are not suitable for this study; Patients who, in the investigators opinion, are mentally or legally incapacitated preventing informed consent or unable to read or understand written material;
•Patients who are unable or unwilling to return to the study center for follow-up visits.