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Trial record 5 of 286 for:    (ARISE)

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

This study has been completed.
Information provided by (Responsible Party):
Aspen Medical Products Identifier:
First received: January 23, 2014
Last updated: July 1, 2014
Last verified: July 2014
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 Intervention
Back Pain
Other: Summit 456 TLSO

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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)

Resource links provided by NLM:

Further study details as provided by Aspen Medical Products:

Primary Outcome Measures:
  • Mean difference in the Oswestry Disability Index Scores of the intervention versus control groups [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • ODI scores between the intervention group versus control group [ Time Frame: Weeks 8, 12, 16, 20 and 24 ] [ Designated as safety issue: No ]
  • SF-26v2 Survey scores in the intervention versus the control group [ Time Frame: Baseline and weeks 4, 8, 12 and 24. ] [ Designated as safety issue: No ]
  • Cost and return on investment of the LSO intervention [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Number of adverse events associated with the LSO intervention [ Time Frame: Baseline and weeks 2, 3, 4, 8, 12, 16, 20 and 24 ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: June 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02180776

Sponsors and Collaborators
Aspen Medical Products
Principal Investigator: Daniel J Schaffer, MD Southeastern Integrated Medical
  More Information

Responsible Party: Aspen Medical Products Identifier: NCT02180776     History of Changes
Other Study ID Numbers: CPR-ORTHO01-2012 
Study First Received: January 23, 2014
Last Updated: July 1, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Back Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases processed this record on October 21, 2016