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Upright Back Posture Device Study

Primary Purpose

Back Pain, Postural Low Back Pain, Lower Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Upright Go Device
Ergonomic Handout
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Back Pain focused on measuring Upright, Back, Posture, Back pain

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Columbia University Irving Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Upright Go Device Group

Control Group

Arm Description

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.

The control group will receive a 15-20 minute instruction on proper posture by the physician and will receive an ergonomic handout.

Outcomes

Primary Outcome Measures

Score on Numeric Pain Rating Scale (NPRS)
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
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'.

Secondary Outcome Measures

Full Information

First Posted
December 6, 2018
Last Updated
November 2, 2019
Sponsor
Columbia University
Collaborators
Upright Technologies Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03769246
Brief Title
Upright Back Posture Device Study
Official Title
Upright Back Posture Device Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
February 8, 2018 (Actual)
Primary Completion Date
August 29, 2019 (Actual)
Study Completion Date
August 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
Upright Technologies Ltd.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain, Postural Low Back Pain, Lower Back Pain
Keywords
Upright, Back, Posture, Back pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Upright Go Device Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
The control group will receive a 15-20 minute instruction on proper posture by the physician and will receive an ergonomic handout.
Intervention Type
Device
Intervention Name(s)
Upright Go Device
Other Intervention Name(s)
Upright Technologies
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Ergonomic Handout
Intervention Description
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 Measure Information:
Title
Score on Numeric Pain Rating Scale (NPRS)
Description
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").
Time Frame
4 weeks
Title
Score on the PROMIS Pain Interference Short Form 6b
Description
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'.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna-Christina Bevelaqua, M.D
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Upright Back Posture Device Study

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