Upright Back Posture Device Study

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

Tracking Information

• First Submitted Date: December 6, 2018
• First Posted Date: December 7, 2018
• Last Update Posted Date: November 5, 2019
• Actual Study Start Date: February 8, 2018
• Actual Primary Completion Date: August 29, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Upright Back Posture Device Study
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Supportive Care

Condition

• Back Pain
• Postural Low Back Pain
• Lower Back Pain

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 2, 2019): 30
• Original Estimated Enrollment (submitted: December 6, 2018): 45
• Actual Study Completion Date: August 29, 2019
• Actual Primary Completion Date: August 29, 2019 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03769246
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Anna-Christina Bevelaqua, Columbia University
• Study Sponsor: Columbia University
• Collaborators: Upright Technologies Ltd.

Investigators

• Principal Investigator: Anna-Christina Bevelaqua, M.D; Columbia University

• PRS Account: Columbia University
• Verification Date: November 2019