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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Kyphosis, Back Pain

Intervention / Treatment
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* Other: Summit 456 TLSO


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>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. | Other: Summit 456 TLSO<br>* Thoracolumbarsacral orthosis<br>|
| Placebo Comparator: Group B<br>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. | Other: Summit 456 TLSO<br>* Thoracolumbarsacral orthosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean difference in the Oswestry Disability Index Scores of the intervention versus control groups |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |