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| Name | Class |
|---|---|
| Upright Technologies | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Upright Go Device Group | Experimental | 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. |
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| Control Group | Active Comparator | The control group will receive a 15-20 minute instruction on proper posture by the physician and will receive an ergonomic handout. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Upright Go Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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.
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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna-Christina Bevelaqua, M.D | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Irving Medical Center | New York | New York | 10032 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Two subjects in the Upright Go Device Group were lost to follow-up. | Posted | Mean | Standard Deviation | score on a scale | 4 weeks |
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Participants participated in the study for a total of 4 weeks, or 1 month.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anna-Christina Bevelaqua | Columbia University Medical Center | (212) 342-0085 | ab3302@cumc.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 7, 2018 | Jun 27, 2024 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D001416 | Back Pain |
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Ergonomic Handout | Other | 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. |
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| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Postural Back Pain | Count of Participants | Participants |
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| OG001 | 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. |
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| 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.
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. | Two subjects in the Upright Go Device Group were lost to follow-up | Posted | Mean | Standard Deviation | score on a scale | 4 weeks |
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| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | 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. | 0 | 15 | 0 | 15 | 0 | 15 |
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| Responses to Question 1: "How much did pain interfere with your enjoyment of life?" (Post) |
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| Responses to Question 2: "How much did pain interfere with your ability to concentrate?" (Pre) |
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| Responses to Question 2: "How much did pain interfere with your ability to concentrate?" (Post) |
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| Responses to Question 3: "How much did pain interfere with your day to day activities?" (Pre) |
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| Responses to Question 3: "How much did pain interfere with your day to day activities?" (Post) |
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| Responses to Q4: "How much did pain interfere with your enjoyment of recreational activities?" (Pre) |
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| Responses to Q4:"How much did pain interfere with your enjoyment of recreational activities?" (Post) |
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| Responses to Question 5: "How much did pain interfere with doing your tasks away from home?" (Pre) |
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| Responses to Question 5:"How much did pain interfere with doing your tasks away from home?" (Post) |
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| Responses to Question 6: "How often did pain keep you from socializing with others?" (Pre) |
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| Responses to Question 6: "How often did pain keep you from socializing with others?" (Post) |
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