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

Back Pain Clinical Trial

— ARISE  

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 With Kyphosis (The ARISE Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02180776
• Other study ID #: CPR-ORTHO01-2012
• Status: Completed
• Phase: N/A
• First received: January 23, 2014
• Last updated: July 1, 2014
• Start date: June 2012
• Est. completion date: March 2014

Study information

• Verified date: July 2014
• Source: Aspen Medical Products
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Kyphosis

Intervention

Other:
• Summit 456 TLSO
Thoracolumbarsacral orthosis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aspen Medical Products

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	ODI scores between the intervention group versus control group		Weeks 8, 12, 16, 20 and 24	No
Other	SF-26v2 Survey scores in the intervention versus the control group		Baseline and weeks 4, 8, 12 and 24.	No
Other	Cost and return on investment of the LSO intervention		24 weeks	No
Other	Number of adverse events associated with the LSO intervention		Baseline and weeks 2, 3, 4, 8, 12, 16, 20 and 24	No
Primary	Mean difference in the Oswestry Disability Index Scores of the intervention versus control groups		4 weeks	No
Secondary	Measured amount of opioid medication consumed in the intervention group versus control group		Baseline and weeks 2,3,4,8,12,16,20 and 24	No