Back PainNCT03769246

Upright Back Posture Device Study

A study testing Upright Go Device and Ergonomic Handout in people with Back Pain and Postural Low Back Pain, run by Columbia University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 50 years
Conditions the study is for: Back Pain, Postural Low Back Pain, Lower Back Pain
What is being tested?: Upright Go Device and Ergonomic Handout
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 8 Feb 2018to 29 Aug 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Postural-related back pain

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

Columbia University Irving Medical Center
New York, New York, 10032

Other trials in United States

About this study

Read the 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.

Conditions: Back Pain, Postural Low Back Pain, Lower Back Pain
Being tested: Upright Go Device, Ergonomic Handout
Keywords: Upright, Back, Posture, Back pain
Medical subject headings: Back Pain, Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Upright Go DeviceDevice
Also called Upright Technologies
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.
Ergonomic HandoutOther
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 groups in NCT03769246
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Ergonomic Handout

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Feb 201829 Aug 2019

First posted7 Dec 2018
Study start8 Feb 2018
Primary completion29 Aug 2019
Study completion29 Aug 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Back PainStudies of the same condition, open and under way.
More trials run by Columbia UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03769246
Sponsor's protocol ID: AAAR4123
Status last verified: Jun 2024
First submitted: 6 Dec 2018
Last updated: 1 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Upright Back Posture Device Study
ClinicalTrials.gov ID: NCT03769246
Acronym / sponsor ID: AAAR4123
Conditions: Back Pain, Postural Low Back Pain, Lower Back Pain
Keywords: Upright, Back, Posture, Back pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Columbia UniversityUniversity, hospital or other
Collaborators: Upright Technologies
Study start: 8 Feb 2018 (actual)
Primary completion: 29 Aug 2019 (actual)
Study completion: 29 Aug 2019 (actual)
First posted: 7 Dec 2018 (actual)
Results: Posted 1 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Upright Go Device Group	Experimental	Device: Upright Go DevicePatients 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.
Control Group	Active comparator	Other: Ergonomic HandoutThe control group will receive a 15-20 minute instruction on proper posture by the physician and will receive an ergonomic handout.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Postural-related back pain

Key exclusion criteria (3 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Upright Go DeviceAlso: Upright TechnologiesParticipants 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.	Device	Upright Go Device Group
Ergonomic HandoutParticipants 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.	Other	Control Group

Primary outcome

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"). 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.
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 "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.

Results and safety

Results posted to the registry on 1 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Upright Go Device Group	15	13
Control Group	15	15

Primary outcome: Score on Numeric Pain Rating Scale (NPRS)

Time frame: 4 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Upright Go Device Group n = 15	Control Group n = 15
NPRS Pre	2.54 (1.81)	2.44 (1.99)
NPRS Post	1.75 (1.45)	1.49 (1.17)

Population analysed: Two subjects in the Upright Go Device Group were lost to follow-up.

Primary outcome: Score on the PROMIS Pain Interference Short Form 6b

Time frame: 4 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Upright Go Device Group n = 15	Control Group n = 15
Responses to Question 1: "How much did pain interfere with your enjoyment of life?" (Pre)	2.40 (1.06)	2.53 (1.19)
Responses to Question 1: "How much did pain interfere with your enjoyment of life?" (Post)	1.85 (0.90)	1.60 (0.51)
Responses to Question 2: "How much did pain interfere with your ability to concentrate?" (Pre)	2.27 (1.03)	2.47 (1.06)
Responses to Question 2: "How much did pain interfere with your ability to concentrate?" (Post)	1.69 (0.63)	1.67 (0.62)
Responses to Question 3: "How much did pain interfere with your day to day activities?" (Pre)	2.40 (1.24)	2.53 (1.19)
Responses to Question 3: "How much did pain interfere with your day to day activities?" (Post)	1.62 (0.96)	1.67 (0.62)
Responses to Q4: "How much did pain interfere with your enjoyment of recreational activities?" (Pre)	2.33 (1.11)	2.47 (1.06)
Responses to Q4:"How much did pain interfere with your enjoyment of recreational activities?" (Post)	1.54 (0.78)	1.40 (0.51)

Population analysed: Two subjects in the Upright Go Device Group were lost to follow-up

Adverse events

Time frame: Participants participated in the study for a total of 4 weeks, or 1 month.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Upright Go Device Group	0 of 15 (0%)	0 of 15 (0%)	0 of 15
Control Group	0 of 15 (0%)	0 of 15 (0%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Back Pain

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anna-Christina Bevelaqua, M.D principal investigator

Columbia University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Upright Go Device and Ergonomic Handout in people with Back Pain and Postural Low Back Pain, run by Columbia University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Score on Numeric Pain Rating Scale (NPRS) (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03769246.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2024.