Effectiveness of Inelastic LSO Versus Standard Medical Treatment for Back Pain Associated With Kyphosis (ARISE)
Primary Purpose
Kyphosis, Back Pain
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Summit 456 TLSO
Sponsored by
About this trial
This is an interventional treatment trial for Kyphosis
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Group A
Group B
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Mean difference in the Oswestry Disability Index Scores of the intervention versus control groups
Secondary Outcome Measures
Measured amount of opioid medication consumed in the intervention group versus control group
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02180776
Brief Title
Effectiveness of Inelastic LSO Versus Standard Medical Treatment for Back Pain Associated With Kyphosis
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aspen Medical Products
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kyphosis, Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group B
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Summit 456 TLSO
Intervention Description
Thoracolumbarsacral orthosis
Primary Outcome Measure Information:
Title
Mean difference in the Oswestry Disability Index Scores of the intervention versus control groups
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Measured amount of opioid medication consumed in the intervention group versus control group
Time Frame
Baseline and weeks 2,3,4,8,12,16,20 and 24
Other Pre-specified Outcome Measures:
Title
ODI scores between the intervention group versus control group
Time Frame
Weeks 8, 12, 16, 20 and 24
Title
SF-26v2 Survey scores in the intervention versus the control group
Time Frame
Baseline and weeks 4, 8, 12 and 24.
Title
Cost and return on investment of the LSO intervention
Time Frame
24 weeks
Title
Number of adverse events associated with the LSO intervention
Time Frame
Baseline and weeks 2, 3, 4, 8, 12, 16, 20 and 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel J Schaffer, MD
Organizational Affiliation
Southeastern Integrated Medical
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Inelastic LSO Versus Standard Medical Treatment for Back Pain Associated With Kyphosis
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