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

NCT02180776 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2014-07-03

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Summit 456 TLSO

Thoracolumbarsacral orthosis

Sponsors & Collaborators

  • Aspen Medical Products

    lead OTHER

Principal Investigators

  • Daniel J Schaffer, MD · Southeastern Integrated Medical

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2014-03-31
Completion
2014-03-31

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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 NCT02180776 on ClinicalTrials.gov