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

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)

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.

Study Overview

• Status: Completed
• Conditions: Back Pain; Kyphosis
• Intervention / Treatment: Other: Summit 456 TLSO

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; 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; Thoracolumbarsacral orthosis
Placebo Comparator: Group B; 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; Thoracolumbarsacral orthosis

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Time Frame
ODI scores between the intervention group versus control group	Weeks 8, 12, 16, 20 and 24
SF-26v2 Survey scores in the intervention versus the control group	Baseline and weeks 4, 8, 12 and 24.
Cost and return on investment of the LSO intervention	24 weeks
Number of adverse events associated with the LSO intervention	Baseline and weeks 2, 3, 4, 8, 12, 16, 20 and 24

Collaborators and Investigators

• Sponsor: Aspen Medical Products
• Investigators: Principal Investigator: Daniel J Schaffer, MD, Southeastern Integrated Medical

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: January 23, 2014
• First Submitted That Met QC Criteria: July 1, 2014
• First Posted (Estimate): July 3, 2014

Study Record Updates

• Last Update Posted (Estimate): July 3, 2014
• Last Update Submitted That Met QC Criteria: July 1, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Back Pain; Kyphosis
• Other Study ID Numbers: CPR-ORTHO01-2012