Upright Back Posture Device Study
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|ClinicalTrials.gov Identifier: NCT03769246|
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : December 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Back Pain Postural Low Back Pain Lower Back Pain||Device: Upright Go Device Other: Ergonomic Handout||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Upright Back Posture Device Study|
|Actual Study Start Date :||February 8, 2018|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||September 2019|
Experimental: 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.
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 Name: Upright Technologies
Active Comparator: Control Group
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
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.
- 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").
- 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 "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'.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769246
|Contact: Anna-Christina Bevelaqua, M.Dfirstname.lastname@example.org|
|Contact: Nancy Lee, M.Semail@example.com|
|United States, New York|
|Columbia University Irving Medical Center||Recruiting|
|New York, New York, United States, 10032|
|Contact: Nancy Lee, M.S 212-305-9416 firstname.lastname@example.org|
|Principal Investigator: Anna-Christina Bevelaqua, M.D|
|Principal Investigator:||Anna-Christina Bevelaqua, M.D||Columbia University|