Upright Back Posture Device Study

NCT ID: NCT03769246

Last Updated: 2024-07-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-08

Study Completion Date

2019-08-29

Brief Summary

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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

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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

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Back Pain Postural Low Back Pain Lower Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Upright Go Device

Intervention Type 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.

Control Group

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

Group Type ACTIVE_COMPARATOR

Ergonomic Handout

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type OTHER

Other Intervention Names

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Upright Technologies

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Upright Technologies

INDUSTRY

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Joel Stein, MD

Professor of Physical Medicine and Rehabilitation; Chair of Department of Rehabilitation and Regenerative Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anna-Christina Bevelaqua, M.D

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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Columbia University Irving Medical Center

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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AAAR4123

Identifier Type: -

Identifier Source: org_study_id

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