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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
Aspen Medical Products
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kyphosis

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 23, 2014
    Last Updated
    July 1, 2014
    Sponsor
    Aspen Medical Products
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    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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