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Upright Back Posture Device Study

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ClinicalTrials.gov Identifier: NCT03769246
Recruitment Status : Completed
First Posted : December 7, 2018
Last Update Posted : November 5, 2019
Sponsor:
Collaborator:
Upright Technologies Ltd.
Information provided by (Responsible Party):
Anna-Christina Bevelaqua, Columbia University

Tracking Information
First Submitted Date  ICMJE December 6, 2018
First Posted Date  ICMJE December 7, 2018
Last Update Posted Date November 5, 2019
Actual Study Start Date  ICMJE February 8, 2018
Actual Primary Completion Date August 29, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 6, 2018)
  • Score on Numeric Pain Rating Scale (NPRS) [ Time Frame: 4 weeks ]
    The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
  • Score on the PROMIS Pain Interference Short Form 6b [ Time Frame: 4 weeks ]
    The Patient-Reported Outcome Measurement Information System (PROMIS) Pain Interference Short Form utilizes a 7-day recall period (items include the phrase "the past 7 days"). Individuals are to score pain interference for each of the 6 questions from a scale of 1 indicating 'not at all' to 5 indicating 'very much'.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Upright Back Posture Device Study
Official Title  ICMJE Upright Back Posture Device Study
Brief Summary This is a randomized controlled study to determine if patients between the ages of 18-50 years, with posture related low back pain, who use the Upright device demonstrate improved pain control and self perception of posture compared to those given standard ergonomic instruction.
Detailed Description Back pain is a common complaint among students. For many, back pain is directly related to poor posture while sitting and standing. Those who spend prolonged time sitting in poor posture often develop muscular imbalances leading to tight chest muscles and weakness in back muscles. The Upright system is a device which helps provide a sensory reminder to alert users when their posture is poor. The purpose of this study is to determine if patients who use the upright posture device demonstrate improved pain control and self perception of posture when compared to those given standard ergonomic instruction.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Back Pain
  • Postural Low Back Pain
  • Lower Back Pain
Intervention  ICMJE
  • Device: Upright Go Device
    Participants will be asked to use the Upright device everyday for four (4) weeks. After four (4) weeks, the participants will be asked to complete a couple of questionnaires regarding their pain scale and back posture.
    Other Name: Upright Technologies
  • Other: Ergonomic Handout
    Participants will be asked to use the ergonomic handout everyday for four (4) weeks. After four (4) weeks, the participants will be asked to complete a couple of questionnaires regarding their pain scale and back posture.
Study Arms  ICMJE
  • Experimental: Upright Go Device Group

    Patients receiving the Upright device will have a brief training on the use of the device and proper posture. They will be asked to download the Upright app on their phone from the Playstore.

    Patients will wear the device once daily for training. They will attach the device applying an adhesive on their upper back, as instructed, and the device will be attached to the adhesive by velcro. Once completed they should remove adhesive.

    Intervention: Device: Upright Go Device
  • Active Comparator: Control Group
    The control group will receive a 15-20 minute instruction on proper posture by the physician and will receive an ergonomic handout.
    Intervention: Other: Ergonomic Handout
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 2, 2019)
30
Original Estimated Enrollment  ICMJE
 (submitted: December 6, 2018)
45
Actual Study Completion Date  ICMJE August 29, 2019
Actual Primary Completion Date August 29, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Postural-related back pain

Exclusion Criteria:

  • A diagnosis of significant scoliosis, herniated/bulging disc, lumbar spondylolysis, radiculitis, facet arthrosis, fibromyalgia, rheumatoid arthritis, seronegative spondyloarthropathy.
  • Neurologic deficits on exam
  • Currently in physical therapy (PT)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03769246
Other Study ID Numbers  ICMJE AAAR4123
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Anna-Christina Bevelaqua, Columbia University
Study Sponsor  ICMJE Columbia University
Collaborators  ICMJE Upright Technologies Ltd.
Investigators  ICMJE
Principal Investigator: Anna-Christina Bevelaqua, M.D Columbia University
PRS Account Columbia University
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP