Lower Back PainNCT02474732
Usability Study for the Beactive Brace Instructions for Use
A study testing Beactive(r) Brace in people with Lower Back Pain, run by Benjamin L. England and Associates, LLC.
Trial summary
FDA requires that the user's guide be provided with any over-the-counter (OTC) medical device. It is beneficial to demonstrate that the user's guide for a new medical device is broadly comprehensible where the device will be provided without prescription and direct physician counseling. Read more about this study
- Who is it for?
- Ages 22 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Lower Back Pain
- What is being tested?
- Beactive(r) Brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must be male or female, between the ages of ages 22 to 79 years (inclusive);
- Subjects must understand and execute an Individual Consent Form (ICF) and complete a Medical History Form;
- Subjects must be in general good health, except for back pain;
- Subjects must have a history of lower back pain with radiating pain down the leg;
- Subjects must have completed the 10th grade and must be able to read and comprehend English;
- Subjects must be willing to report any medications taken during the trial and refrain from taking medication that might reduce back pain; and
- Subjects must be considered reliable and capable of following directions.
Who cannot join
- Subjects in ill health or taking medication, other than birth control, which could influence the purpose,integrity or outcome of the trial; or
- Subjects having any visible skin disease, which might be confused with a skin reaction from the test material.
About this study
Official title: Assessment of User Comprehension of the BeActive™Brace User Guide
FDA requires that the user's guide be provided with any over-the-counter (OTC) medical device. It is beneficial to demonstrate that the user's guide for a new medical device is broadly comprehensible where the device will be provided without prescription and direct physician counseling. Therefore, a population of subjects will be tested to determine whether they can properly use the BeActive Brace device after reading the user's guide.
Read the detailed description
The primary objective of this clinical trial is to evaluate the ability of approximately 40 literate adults to understand the label instructions for deploying the Beactive(r) Brace device as described in the user's guide, without physician direction. The primary endpoint of this clinical trial is the successful completion of all essential tasks required for Beactive(r) Brace deployment by a subject.
Subjects will be seated at a table facing a video camera, so Investigators and the Sponsor may observe the subject via closed circuit television. Subjects will be given the user's guide for the Beactive(r) Brace device. The subject will then be asked to deploy the Beactive(r) Brace device according to their understanding following the user's guide. For this clinical trial, deploying is defined as completing the following two tasks.
- Applying the Beactive(r) Brace device to the knee area according to the user's guide.
- Correctly positioning the pressure pad according to the user's guide.
If the tasks can be completed with no intervention, the subject would be judged to have a "comprehensive" level of success. If intervention was required and helpful, and the subject was able to complete all essential tasks, the level of success would be judged "sufficient." The steps where intervention took place will be recorded.
Intervention will be allowed and documented if subjects have difficulty with a specific task. The subject will raise their hand and a technician will be available for assistance. The frequency and type of intervention will be documented.
A Study Coordinator will complete an observer questionnaire for each subject based on their observation of each subject's ability to use the Beactive device correctly. Each subject will complete a user questionnaire, which will confirm their understanding of the user's guide and give them the opportunity to provide feedback and suggestions for improving the user's guide.
- Conditions
- Lower Back Pain
- Being tested
- Beactive(r) Brace
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beactive(r) BraceDevice
Determine if the subjects are able to understand and follow the directions to apply the Beactive Brace.
| Study group | Role | What they receive |
|---|---|---|
| Usability | Other | Determine if the subjects are able to understand and follow the directions to apply the Beactive Brace. Receives: Device: Beactive(r) Brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Correctly Following Instructions for Use
Subjects were observed as they read the instructions for use and applied the Beactive(r) Brace.
Measured: Five minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benjamin L. England and Associates, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Caswell, Study director, Consumer Product Testing Compahy, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02474732
- Sponsor's protocol ID
- C15-0419
- Status last verified
- Jan 2017
- First submitted
- 12 Jun 2015
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Redacted individual participant data is available through the Freedom of Information Act process through the FDA
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of User Comprehension of the BeActive™Brace User Guide
- ClinicalTrials.gov ID
- NCT02474732
- Acronym / sponsor ID
- C15-0419
- Conditions
- Lower Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Benjamin L. England and Associates, LLCUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Feb 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 18 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
FDA requires that the user's guide be provided with any over-the-counter (OTC) medical device. It is beneficial to demonstrate that the user's guide for a new medical device is broadly comprehensible where the device will be provided without prescription and direct physician counseling. Therefore, a population of subjects will be tested to determine whether they can properly use the BeActive Brace device after reading the user's guide.
Detailed description
The primary objective of this clinical trial is to evaluate the ability of approximately 40 literate adults to understand the label instructions for deploying the Beactive(r) Brace device as described in the user's guide, without physician direction. The primary endpoint of this clinical trial is the successful completion of all essential tasks required for Beactive(r) Brace deployment by a subject.
Subjects will be seated at a table facing a video camera, so Investigators and the Sponsor may observe the subject via closed circuit television. Subjects will be given the user's guide for the Beactive(r) Brace device. The subject will then be asked to deploy the Beactive(r) Brace device according to their understanding following the user's guide. For this clinical trial, deploying is defined as completing the following two tasks.
- Applying the Beactive(r) Brace device to the knee area according to the user's guide.
- Correctly positioning the pressure pad according to the user's guide.
If the tasks can be completed with no intervention, the subject would be judged to have a "comprehensive" level of success. If intervention was required and helpful, and the subject was able to complete all essential tasks, the level of success would be judged "sufficient." The steps where intervention took place will be recorded.
Intervention will be allowed and documented if subjects have difficulty with a specific task. The subject will raise their hand and a technician will be available for assistance. The frequency and type of intervention will be documented.
A Study Coordinator will complete an observer questionnaire for each subject based on their observation of each subject's ability to use the Beactive device correctly. Each subject will complete a user questionnaire, which will confirm their understanding of the user's guide and give them the opportunity to provide feedback and suggestions for improving the user's guide.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Usability | Other | Device: Beactive(r) BraceDetermine if the subjects are able to understand and follow the directions to apply the Beactive Brace. |
Who may qualify
- Ages
- 22 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects must be male or female, between the ages of ages 22 to 79 years (inclusive);
- Subjects must understand and execute an Individual Consent Form (ICF) and complete a Medical History Form;
- Subjects must be in general good health, except for back pain;
- Subjects must have a history of lower back pain with radiating pain down the leg;
- Subjects must have completed the 10th grade and must be able to read and comprehend English;
Key exclusion criteria (2 listed)
- Subjects in ill health or taking medication, other than birth control, which could influence the purpose,integrity or outcome of the trial; or
- Subjects having any visible skin disease, which might be confused with a skin reaction from the test material.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beactive(r) BraceDetermine if the subjects are able to understand and follow the directions to apply the Beactive Brace. | Device | Usability |
Primary outcome
Number of Subjects Correctly Following Instructions for Use
Time frame: Five minutes
Subjects were observed as they read the instructions for use and applied the Beactive(r) Brace.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
- Individual participant dataSharing planned: No. Redacted individual participant data is available through the Freedom of Information Act process through the FDA
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Caswell study director
Consumer Product Testing Compahy, Inc.
Questions about this trial
What is this clinical trial studying?
A study testing Beactive(r) Brace in people with Lower Back Pain, run by Benjamin L. England and Associates, LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects Correctly Following Instructions for Use (time frame: Five minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2017.