Back Pain, Lower Back Pain, Postural Low Back Pain
Conditions
Keywords
Upright, Back, Posture, Back pain
Brief 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.
Detailed 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.
Interventions
DEVICEUpright 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.
OTHERErgonomic 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.
Sponsors
Upright Technologies
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Score on Numeric Pain Rating Scale (NPRS) | 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). 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. |
| Score on the PROMIS Pain Interference Short Form 6b | 4 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| 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. | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Upright Go Device Group | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 15 Participants | 30 Participants |
| Age, Continuous | 29.3 Years STANDARD_DEVIATION 6.6 | 30.2 Years STANDARD_DEVIATION 7.1 | 29.8 Years STANDARD_DEVIATION 6.8 |
| Postural Back Pain | 15 Participants | 15 Participants | 30 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 15 participants | 15 participants | 30 participants |
| Sex: Female, Male Female | 8 Participants | 12 Participants | 20 Participants |
| Sex: Female, Male Male | 7 Participants | 3 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
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). 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.
Time frame: 4 weeks
Population: Two subjects in the Upright Go Device Group were lost to follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Upright Go Device Group | Score on Numeric Pain Rating Scale (NPRS) | NPRS Pre | 2.54 score on a scale | Standard Deviation 1.81 |
| Upright Go Device Group | Score on Numeric Pain Rating Scale (NPRS) | NPRS Post | 1.75 score on a scale | Standard Deviation 1.45 |
| Control Group | Score on Numeric Pain Rating Scale (NPRS) | NPRS Pre | 2.44 score on a scale | Standard Deviation 1.99 |
| Control Group | Score on Numeric Pain Rating Scale (NPRS) | NPRS Post | 1.49 score on a scale | Standard Deviation 1.17 |
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 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.
Time frame: 4 weeks
Population: Two subjects in the Upright Go Device Group were lost to follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Upright Go Device Group | 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 0.9 |
| Upright Go Device Group | 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 |
| Upright Go Device Group | 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 |
| Upright Go Device Group | 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 |
| Upright Go Device Group | 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 |
| Upright Go Device Group | 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 |
| Upright Go Device Group | 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 |
| Upright Go Device Group | 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 |
| Upright Go Device Group | 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 |
| Upright Go Device Group | 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 |
| Upright Go Device Group | 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 |
| Upright Go Device Group | 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 |
| Control Group | Score on the PROMIS Pain Interference Short Form 6b | Responses to Question 6: How often did pain keep you from socializing with others? (Post) | 1.13 score on a scale | Standard Deviation 0.35 |
| Control Group | Score on the PROMIS Pain Interference Short Form 6b | Responses to Question 1: How much did pain interfere with your enjoyment of life? (Pre) | 2.53 score on a scale | Standard Deviation 1.19 |
| Control Group | Score on the PROMIS Pain Interference Short Form 6b | Responses to Question 1: How much did pain interfere with your enjoyment of life? (Post) | 1.60 score on a scale | Standard Deviation 0.51 |
| Control Group | Score on the PROMIS Pain Interference Short Form 6b | Responses to Question 2: How much did pain interfere with your ability to concentrate? (Pre) | 2.47 score on a scale | Standard Deviation 1.06 |
| Control Group | Score on the PROMIS Pain Interference Short Form 6b | Responses to Question 2: How much did pain interfere with your ability to concentrate? (Post) | 1.67 score on a scale | Standard Deviation 0.62 |
| Control Group | 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) | 2.53 score on a scale | Standard Deviation 1.19 |
| Control Group | 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) | 1.67 score on a scale | Standard Deviation 0.62 |
| Control Group | Score on the PROMIS Pain Interference Short Form 6b | Responses to Q4: How much did pain interfere with your enjoyment of recreational activities? (Pre) | 2.47 score on a scale | Standard Deviation 1.06 |
| Control Group | Score on the PROMIS Pain Interference Short Form 6b | Responses to Q4:How much did pain interfere with your enjoyment of recreational activities? (Post) | 1.40 score on a scale | Standard Deviation 0.51 |
| Control Group | 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) | 2.40 score on a scale | Standard Deviation 1.35 |
| Control Group | 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) | 1.33 score on a scale | Standard Deviation 0.62 |
| Control Group | Score on the PROMIS Pain Interference Short Form 6b | Responses to Question 6: How often did pain keep you from socializing with others? (Pre) | 1.47 score on a scale | Standard Deviation 0.83 |