Clinical Trial: Effectiveness of Inelastic LSO Versus Standard Medical Treatment for Back Pain Associated With Kyphosis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Wi

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.

Detailed Summary:
Sponsor: Aspen Medical Products

Current Primary Outcome: Mean difference in the Oswestry Disability Index Scores of the intervention versus control groups [ Time Frame: 4 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Measured amount of opioid medication consumed in the intervention group versus control group [ Time Frame: Baseline and weeks 2,3,4,8,12,16,20 and 24 ]

Original Secondary Outcome: Same as current

Information By: Aspen Medical Products

Dates:
Date Received: January 23, 2014
Date Started: June 2012
Date Completion:
Last Updated: July 1, 2014
Last Verified: July 2014