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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02180776
Recruitment Status : Completed
First Posted : July 3, 2014
Last Update Posted : July 3, 2014
Sponsor:
Information provided by (Responsible Party):
Aspen Medical Products

Study Description
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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.

Condition or disease Intervention/treatment Phase
Kyphosis Back Pain Other: Summit 456 TLSO Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Mean difference in the Oswestry Disability Index Scores of the intervention versus control groups [ Time Frame: 4 weeks ]

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

Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02180776


Sponsors and Collaborators
Aspen Medical Products
Investigators
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Principal Investigator: Daniel J Schaffer, MD Southeastern Integrated Medical
More Information
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Responsible Party: Aspen Medical Products
ClinicalTrials.gov Identifier: NCT02180776    
Other Study ID Numbers: CPR-ORTHO01-2012
First Posted: July 3, 2014    Key Record Dates
Last Update Posted: July 3, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Kyphosis
Back Pain
Pain
Neurologic Manifestations
 Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases