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

Not Applicable

Completed

• Conditions: Kyphosis; Back Pain
• Interventions: Other: Summit 456 TLSO

• Registration Number: NCT02180776
• Lead Sponsor: Aspen Medical Products

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 Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2014-01-23
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-07
• Study First Submitted QC: 2014-07-01
• Last Update Submitted: 2014-07-01
• Study First Posted: 2014-07-03
• Last Update Posted: 2014-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group A	Summit 456 TLSO	Patients assigned to group A wore the Summit 456 TLSO (intervention) for four weeks in phase 1 of the study, followed by four weeks of observation (control) in phase 2.
Group B	Summit 456 TLSO	Patients assigned to group B started four weeks of observation (control) in phase 1, followed by four weeks of summit 456 TLSO (intervention) in phase 2 of the study.

Primary Outcome Measures

Name	Time	Method
Mean difference in the Oswestry Disability Index Scores of the intervention versus control groups	4 weeks

Secondary Outcome Measures

Name	Time	Method
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