Trials / Completed
CompletedNCT02180776
Effectiveness of Inelastic LSO Versus Standard Medical Treatment for Back Pain Associated With Kyphosis
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)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Aspen Medical Products · Academic / Other
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| OTHER | Summit 456 TLSO | Thoracolumbarsacral orthosis |
Timeline
- Start date
- 2012-06-01
- Primary completion
- 2014-03-01
- Completion
- 2014-03-01
- First posted
- 2014-07-03
- Last updated
- 2014-07-03
Source: ClinicalTrials.gov record NCT02180776. Inclusion in this directory is not an endorsement.