Upright Back Posture Device Study

NCT03769246 | Completed Results FDA Device

• 1 other identifier: AAAR4123
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Back Pain; Postural Low Back Pain; Lower Back Pain

Keywords

Upright; Back; Posture; Back pain

Outcome Measures

Primary Outcomes (2)

• 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"). Averages were taken of each group, pre and post intervention. A higher score represents a worse outcome, and a lower score represents a better outcome.

  4 weeks

• 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 "In the past 7 days..."). Individuals are to score pain interference for each of the 6 questions from a scale of 1 to 5. 1. = Not at all 2. = A little bit 3. = Somewhat 4. = Quite a bit 5. = Very Much Scores are collected and analyzed as individual questions, and not as an aggregate total. Averages were taken of each question, for each group, pre and post intervention. A higher score represents a worse outcome and a lower score represents a better outcome.

  4 weeks

Study Arms (2)

Upright Go Device Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

Interventions

Upright Go Device 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.

Also known as: Upright Technologies

Upright Go Device Group

Ergonomic Handout OTHER

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Postural-related back pain

You may not qualify if:

• 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)

Sponsors & Collaborators

• Columbia University: lead
• Upright Technologies: collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Back Pain; Low Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Anna-Christina Bevelaqua
• Organization: Columbia University Medical Center

ab3302@cumc.columbia.edu

(212) 342-0085

Study Officials

• Anna-Christina Bevelaqua, M.D

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Physical Medicine and Rehabilitation; Chair of Department of Rehabilitation and Regenerative Medicine

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: December 7, 2018
• Study Start: February 8, 2018
• Primary Completion: August 29, 2019
• Study Completion: August 29, 2019
• Last Updated: July 1, 2024
• Results First Posted: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)