Upright Back Posture Device Study
Phase: NA
Conditions: Back Pain, Postural Low Back Pain, Lower Back Pain
Sponsor: Columbia University

Upright Back Posture 
Device Study
ClinicalTrials.gov ID: NCT03769246 
IRB approval date: December 7, 2018

Protocol Version Date: 07Dec2018 
1 
Research Question(s)/Hypothesis(es): 
The purpose of the this study is to determine if patients with back pain who use a device that provides a 
proprioceptive reminder regarding posture (UPRIGHT device) demonstrate improved pain control and 
self perception of posture over those who receive a brief instruction on posture and an ergonomic 
handout.  
Hypothesis: There will be no difference in back pain score or self perception of posture between those 
using the UPRIGHT device and those receiving posture/ergonomic instruction alone. 
Scientific Abstract: 
Back pain is one of the most common conditions among the adult population (1). There is evidence that 
individuals with back pain have impaired motor control of trunk muscles and delayed neuromuscular 
recruitment (2,3). Poor posture has been associated with spinal extensor weakness, back pain, and 
lower quality of life scores (4). Those who spend prolonged time sitting in poor posture often develop 
muscular imbalances leading to tight chest muscles and weakness in back muscles. Back pain is 
commonly treated with flexibility and strengthening and exercises as well and a health education 
regarding proper posture (5). The purpose of the this study is to determine if patients with back pain 
who use a device that provides a proprioceptive reminder regarding posture (UPRIGHT device) 
demonstrate improved pain control and self perception of posture over those who receive a brief 
instruction on posture and an ergonomic handout.  
Hypothesis: There will be no difference in back pain score or self perception of posture between those 
using the UPRIGHT device and those receiving posture/ergonomic instruction alone. This is a 
randomized controlled study to determine if patients between the ages of 18-50, 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. Subjects will complete a baseline 
history, physical exam and questionnaire to assess current pain level.  
Subjects will be randomized into two groups. One group will receive the UPRIGHT device and a 15 
minute tutorial on using the device. Subjects will complete a 4 week training program using the device. 
The control group will receive a 15 minute instruction on proper posture and an ergonomic handout 
explaining how to sit and stand with proper posture. At the end of 4 weeks subjects will be contacted via 
telephone to complete a questionnaire to assess their current pain level, perception of posture, and 
satisfaction with the device. 
References: 
1. Hoy D, Bain C, Williams G, et al. A systematic review of the global prevalence of low back pain.
Arthritis Rheum. 2012 ; 64:2028-2037.
2. Hodges PW, Richardson CA. Inefficient muscular stabilization of the lumbar spine associated with low
back pain. A motor control evaluation of transverse abdominis. Spine (Phila Pa 1976) 21(22):2640-2650.
3. Brumagne S. Cordo P, Lysens R, Verschueren S, Swinnen S (2000). The role of paraspinal muscle
spindles in lumbrosacral position sense in individuals with and without low back pain. Spine (Phila PA
1976) 25 (8):989-994.

Title: Upright Back Posture Device Study (AAAR4123) 
NCT: NCT03769246 
Protocol Version Date: 07Dec2018 
2 
4 . Dunk NM, Callaghan JP. Lumbar spine movement patterns during prolonged sitting differentiate low 
back pain developers from matched asymptomatic controls. Work. 2010;35(1):3–14. doi:10.3233/wor-
2010-0953  
5. Zhang Y, Wan L, Wang X (2014). The effect of health education in patients with chronic low back pain.
Journal of international medical research. 2014; Vol 42(3) 815-820.
Study Population: 
A total of up to 45 participants will be enrolled into this study with a target accrual of 35 participants 
treated. 
This study consists of two groups: 
1. Upright posture device x 4 weeks.
2. Ergonomic instruction (15-20 min) and handout.
The Inclusion Criteria is as follows: 
1. Ages 18-50
2. Postural related back pain
The Exclusion Criteria is as follows: 
1. A diagnosis of significant scoliosis, herniated/bulging disc, lumbar spondylolysis, radiculitis, facet
arthrosis, fibromyalgia, rheumatoid arthritis, seronegative spondyloarthropathy
2. Neurologic deficits on exam
3. Currently in PT
The participants will fall in either one of the following Intervention /exposure groups: Group 1- Upright 
device training x 4 weeks Group 2- Ergonomic training 30 min, ergonomic handout. The control group 
will get the upright device if they still have pain.  
Randomization will be done by research member not in contact with participant using 
www.randomization.com and will use 3 blocks of 10 for randomization. At the end of 4 weeks patient 
will be reassessed with visual analog pain scale, and self preception posture scale. Patients receiving the 
upright device will have a brief training on the use of the device and proper posture. They will use a 
training protocol (attached). The control group will have a 15-20 minute instruction on proper posture 
and an ergonomic handout. 
Patients will be identified by a physician at student health and enrolled by the research team. Informed 
consent will be obtained. 
Study Procedures: 
Subjects with complaints of back pain will be recruited from Columbia University Student Health and 
from Columbia Doctors Physical Medicine and Rehabilitation practice. Subjects will be consented and 
randomized to either the UPRIGHT device group or control group. The UPRIGHT group will get a brief 
training on how to use the device. This will involve downloading the app on subjects phone. We will set 

Title: Upright Back Posture Device Study (AAAR4123) 
NCT: NCT03769246 
Protocol Version Date: 07Dec2018 
3 
up a separate de-identified gmail account which will be used collect data from the device. They will be 
instructed on how and where to attach the device to their back. The subject will be asked to sit with 
proper posture in a chair without leaning against the back rest with both feet flat on the ground. The 
training is once daily and each day the time increase according to the provided training protocol. The 
subjects will wear the device once per day for 4 weeks.  
The subject needs to use a new adhesive (which will be provided) each time they put the device on. The 
device will be calibrated to detect changes in posture. A detailed physical exam as well as medical 
history, family history will be conducted on all participants. Subjects will then be given a 4 week training 
protocol through the app. The control group will have a 15 minute instruction on proper posture and an 
ergonomic handout explaining how to sit and stand with proper posture.  
At the end of 4 weeks subjects will be contacted via telephone to complete a questionnaire to assess 
their current pain level, perception of posture, and satisfaction with the device. At the end of 4 weeks 
participants in the control group will be given an UPRIGHT device if they continue to have pain.  
Prior to recruitment we will pilot the use of this device with 5 healthy controls. The purpose of the pilot 
study is to assess for any difficulties we may encounter with the device and while training with the 
device. 
Recruitment: 
Patients will be identified by a physician at student health or by a Columbia Doctors PM&R physician 
who will first introduce the study to the patients and enrolled by the research team. Informed consent 
will be obtained. Subjects who presents to the Columbia Health Clinic or Columbia Doctors 
Rehabilitation Medicine with complaints of back pain who meet the criteria will be asked to participate 
in our study. Information about the study will be provided and if they choose to participate they will be 
consented by our research coordinator. They will then be scheduled for study assessments. This study is 
completely voluntary. None of residents, students, fellows or employees within our Rehabilitation 
Department will be asked to participate in this study. Recruitment flyers will also be placed in the 
Department of Rehab at CUMC as well as displayed at student health at Columbia University. 
An electronic flyer (attached) will be sent to the graduate school of arts and sciences communication 
department for them to attach to their monthly newsletter sent to the graduate students on our behalf. 
The communication department will not give us their list serve at any time. Graduate students are 
added to this list serve when registered for graduate classes at Columbia University and the 
communications department is the sole owner of this list. An individual who wants to participate in the 
study will contact Adam Blanchard directly and no one from the communication department will ever 
see this information. 
Alex Gomberg, an employee of Upright, will send out the attached email (Upright_email script) to 
individuals who have purchased an Upright device in the past on our behalf. We will never have access 
to these individuals' contact information or listserve. When someone purchases an Upright device they 
are added onto their mailing listserve and agree to receive emails from Upright. Alex and Upright will be 
sending the email referencing our study and provide our contact information. An individual who wants 
to participate in the study will contact Adam Blanchard directly and no one from Upright will ever see 
this information. 

Title: Upright Back Posture Device Study (AAAR4123) 
NCT: NCT03769246 
Protocol Version Date: 07Dec2018 
4 
Study Product: 
UPRIGHT Go App, manufactured by Upright Technologies Ltd., is an app that connects to the device and 
tracks data and provides feedback from the device.  
The Upright Pro is a wearable biofeedback posture trainer. 
Statistical Plan: 
No power analysis will be done, as only one other study has been published using this device. We'll be 
using 30 participants, as this study had 30 subjects participating in study. 
For within subjects, data will be analyzed using paired T-test analysis. For between subjects data will be 
analyzed using ANOVA. Currently there are no similar studies to determine the sample size, we plan to 
analyze the outcomes.