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Upright Back Posture Device Study

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

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.

Condition or disease Intervention/treatment Phase
Back Pain Postural Low Back Pain Lower Back Pain Device: Upright Go Device Other: Ergonomic Handout Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Upright Back Posture Device Study
Actual Study Start Date : February 8, 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

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

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.
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.




Primary Outcome Measures :
  1. 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").

  2. 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'.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

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): NCT03769246


Contacts
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Contact: Anna-Christina Bevelaqua, M.D 212-305-1062 ab3302@cumc.columbia.edu
Contact: Nancy Lee, M.S 212-305-9416 nl2674@cumc.columbia.edu

Locations
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United States, New York
Columbia University Irving Medical Center Recruiting
New York, New York, United States, 10032
Contact: Nancy Lee, M.S    212-305-9416    nl2674@cumc.columbia.edu   
Principal Investigator: Anna-Christina Bevelaqua, M.D         
Sponsors and Collaborators
Columbia University
Upright Technologies Ltd.
Investigators
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Principal Investigator: Anna-Christina Bevelaqua, M.D Columbia University

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Responsible Party: Anna-Christina Bevelaqua, Assistant Professor of Rehabilitation and Regenerative Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT03769246     History of Changes
Other Study ID Numbers: AAAR4123
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Anna-Christina Bevelaqua, Columbia University:
Upright
Back
Posture
Back pain

Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms