Upright Back Posture Device Study

Back Pain Clinical Trial

Official title:

Upright Back Posture Device Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03769246
• Other study ID #: AAAR4123
• Status: Completed
• Phase: N/A
• Start date: February 8, 2018
• Est. completion date: August 29, 2019

Study information

• Verified date: November 2019
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 29, 2019
• Est. primary completion date: August 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Lower Back Pain
• Postural Low 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:
• 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.

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Upright Technologies Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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").	4 weeks
Primary	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 "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'.	4 weeks