Sponsor study identifier
interventional
30
1 country
1
Study Start
February 8, 2018
Actual (reported)Primary Completion
August 29, 2019
Actual (reported)Study Completion
August 29, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 29, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 8, 2018
Actual (reported)December 6, 2018
Actual (reported)December 7, 2018
Actual (reported)August 29, 2019
Actual (reported)August 29, 2019
Actual (reported)July 1, 2024
Actual (reported)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.
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.
4 weeks
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.
The control group will receive a 15-20 minute instruction on proper posture by the physician and will receive an ergonomic handout.
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.
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.
Columbia University Irving Medical Center
New York, New York, 10032, United States
Anna-Christina Bevelaqua, M.D
Columbia University
30 participants (actual enrollment reported by the registry).
First Submitted
December 6, 2018
First Posted
December 7, 2018
Study Start
February 8, 2018
Actual (reported)Aromatherapy Randomization of Pain Management in Adults
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
August 29, 2019
Actual (reported)Study Completion
August 29, 2019
Actual (reported)Last Updated
July 1, 2024
Results First Posted
July 1, 2024
Record last verified: 2024-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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