Trial Outcomes & Findings for Upright Back Posture Device Study (NCT NCT03769246)
NCT ID: NCT03769246
Last Updated: 2024-07-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
4 weeks
Results posted on
2024-07-01
Participant Flow
Participant milestones
| Measure |
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.
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.
|
Control Group
The control group will receive a 15-20 minute instruction on proper posture by the physician and will receive an ergonomic handout.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
13
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Upright Go Device Group
n=15 Participants
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.
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.
|
Control Group
n=15 Participants
The control group will receive a 15-20 minute instruction on proper posture by the physician and will receive an ergonomic handout.
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.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=15 Participants
|
15 Participants
n=15 Participants
|
30 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=30 Participants
|
|
Age, Continuous
|
29.3 Years
STANDARD_DEVIATION 6.6 • n=15 Participants
|
30.2 Years
STANDARD_DEVIATION 7.1 • n=15 Participants
|
29.8 Years
STANDARD_DEVIATION 6.8 • n=30 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=15 Participants
|
12 Participants
n=15 Participants
|
20 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=15 Participants
|
3 Participants
n=15 Participants
|
10 Participants
n=30 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
15 participants
n=15 Participants
|
15 participants
n=15 Participants
|
30 participants
n=30 Participants
|
|
Postural Back Pain
|
15 Participants
n=15 Participants
|
15 Participants
n=15 Participants
|
30 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: Two subjects in the Upright Go Device Group were lost to follow-up.
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.
Outcome measures
| Measure |
Upright Go Device Group
n=15 Participants
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.
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.
|
Control Group
n=15 Participants
The control group will receive a 15-20 minute instruction on proper posture by the physician and will receive an ergonomic handout.
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)
NPRS Pre
|
2.54 score on a scale
Standard Deviation 1.81
|
2.44 score on a scale
Standard Deviation 1.99
|
|
Score on Numeric Pain Rating Scale (NPRS)
NPRS Post
|
1.75 score on a scale
Standard Deviation 1.45
|
1.49 score on a scale
Standard Deviation 1.17
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: Two subjects in the Upright Go Device Group were lost to follow-up
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.
Outcome measures
| Measure |
Upright Go Device Group
n=15 Participants
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.
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.
|
Control Group
n=15 Participants
The control group will receive a 15-20 minute instruction on proper posture by the physician and will receive an ergonomic handout.
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 the PROMIS Pain Interference Short Form 6b
Responses to Question 1: "How much did pain interfere with your enjoyment of life?" (Pre)
|
2.40 score on a scale
Standard Deviation 1.06
|
2.53 score on a scale
Standard Deviation 1.19
|
|
Score on the PROMIS Pain Interference Short Form 6b
Responses to Question 1: "How much did pain interfere with your enjoyment of life?" (Post)
|
1.85 score on a scale
Standard Deviation 0.90
|
1.60 score on a scale
Standard Deviation 0.51
|
|
Score on the PROMIS Pain Interference Short Form 6b
Responses to Question 2: "How much did pain interfere with your ability to concentrate?" (Pre)
|
2.27 score on a scale
Standard Deviation 1.03
|
2.47 score on a scale
Standard Deviation 1.06
|
|
Score on the PROMIS Pain Interference Short Form 6b
Responses to Question 2: "How much did pain interfere with your ability to concentrate?" (Post)
|
1.69 score on a scale
Standard Deviation 0.63
|
1.67 score on a scale
Standard Deviation 0.62
|
|
Score on the PROMIS Pain Interference Short Form 6b
Responses to Question 3: "How much did pain interfere with your day to day activities?" (Pre)
|
2.40 score on a scale
Standard Deviation 1.24
|
2.53 score on a scale
Standard Deviation 1.19
|
|
Score on the PROMIS Pain Interference Short Form 6b
Responses to Question 3: "How much did pain interfere with your day to day activities?" (Post)
|
1.62 score on a scale
Standard Deviation 0.96
|
1.67 score on a scale
Standard Deviation 0.62
|
|
Score on the PROMIS Pain Interference Short Form 6b
Responses to Q4: "How much did pain interfere with your enjoyment of recreational activities?" (Pre)
|
2.33 score on a scale
Standard Deviation 1.11
|
2.47 score on a scale
Standard Deviation 1.06
|
|
Score on the PROMIS Pain Interference Short Form 6b
Responses to Q4:"How much did pain interfere with your enjoyment of recreational activities?" (Post)
|
1.54 score on a scale
Standard Deviation 0.78
|
1.40 score on a scale
Standard Deviation 0.51
|
|
Score on the PROMIS Pain Interference Short Form 6b
Responses to Question 5: "How much did pain interfere with doing your tasks away from home?" (Pre)
|
2.20 score on a scale
Standard Deviation 0.86
|
2.40 score on a scale
Standard Deviation 1.35
|
|
Score on the PROMIS Pain Interference Short Form 6b
Responses to Question 5:"How much did pain interfere with doing your tasks away from home?" (Post)
|
1.69 score on a scale
Standard Deviation 0.63
|
1.33 score on a scale
Standard Deviation 0.62
|
|
Score on the PROMIS Pain Interference Short Form 6b
Responses to Question 6: "How often did pain keep you from socializing with others?" (Pre)
|
1.73 score on a scale
Standard Deviation 0.88
|
1.47 score on a scale
Standard Deviation 0.83
|
|
Score on the PROMIS Pain Interference Short Form 6b
Responses to Question 6: "How often did pain keep you from socializing with others?" (Post)
|
1.15 score on a scale
Standard Deviation 0.38
|
1.13 score on a scale
Standard Deviation 0.35
|
Adverse Events
Upright Go Device Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Anna-Christina Bevelaqua
Columbia University Medical Center
Phone: (212) 342-0085
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place