You have expressed interest in participating in The VIGOR Trial, which is a randomized clinical trial to examine the effects of a novel treatment for low back pain. To determine if you are eligible for this research study we need to ask you some prescreening questions about your medical history, and some of these will be of a personal nature. These questions should take less than 15 minutes.
There is a risk of a loss of confidentiality or privacy, however, this risk is minimized by storing your data in secured databases at Virginia Commonwealth University, with access limited to study personnel and individuals authorized to access data for the purposes of monitoring research.
Participation in this survey is voluntary, and you do not have to answer any question you do not want to answer and you may choose to stop the survey at any time. Choosing not to participate or withdrawing from the survey will result in no penalty or loss of benefits to which you are otherwise entitled.
Based on your answers to these questions we will determine if we can schedule you for an initial screening assessment, which will include a more complete medical history and physical exam to ensure that you are eligible to participate in this study. However, if based on your answer to these questions we determine that you are not eligible for the study, we will only record data that cannot be linked to you personally, but we will keep record of your answers so that we can obtain a better understanding about how low back pain presents. In the future, identifiers might be removed from the information you provide in this survey, and after that removal, the information could be used for other research studies by this study team or another researcher without asking you for additional consent. You will not benefit directly from completing this screening survey, and we do not have plans to return individual results from this survey to you.
As part of this research, we will ask you to share identifiable health information with us and/or permit us to access existing information from your healthcare records. New health information may also be created from study-related tests, procedures, visits, and/or questionnaires. This type of information is considered "Protected Health Information" that is protected by federal law.
The following types of information may be used for the conduct of this research: medical history
VCU and VCU Health are required by law to protect your identifiable health information. By consenting to this study, you authorize VCU/VCU Health to use and/or share your health information for this research. The health information listed above may be used by and/or shared with the following people and groups to conduct, monitor, and oversee the research: Principal Investigator and Research Staff, Health Care Provders at VCU Health, Institutional Review Boards, Government/Health Agencies, others as required by law.
Once your health information has been disclosed to anyone outside of this study, the information may no longer be protected under this authorization. This authorization will expire when the research study is closed, or there is no need to review, analyze and consider the data generated by the research project, whichever is later.
You may change your mind and revoke (take back) the right to use your protected health information at any time. However, even if you revoke this authorization, the researchers may still use or disclose health information they have already collected about you for this study. If you revoke this Authorization, you may no longer be allowed to participate in the research study. To revoke this Authorization, you must write to the Principal Investigator at:
1200 E Broad St, RM B-104b, BOX 980224, Richmond, VA 23298.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Website will include a summary of the results. You can search this Web site at anytime.
The investigator and study staff named below are the best person(s) to contact if you have any questions, complaints, or concerns about your participation in this research:
James Thomas, DPT, Ph.D.
1200 E Broad St, RM B-104b
Box 980224
Richmond, VA 23298
Jthomas32@vcu.edu
If you have general questions about your rights as a participant in this or any other research, or if you wish to discuss problems, concerns or questions, to obtain information, or to offer input about research, you may contact:
Virginia Commonwealth University Office of Research
800 East Leigh Street, Suite 3000, Box 980568, Richmond, VA 23298
(804) 827-2157; https://research.vcu.edu/human_research/volunteers.htm
Do you consent to answer these questions?
* must provide value
Yes
No
First Name
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Last Name:
* must provide value
Today's date
* must provide value
Today Y-M-D Format: Year-Month-Day
You have answered "No" meaning you decline consent to answer the prescreening questions. You will need to consent to answer the prescreening questions if you wish to complete this screening questionnaire.
We are sorry you do not wish to answer the prescreening questions for The VIGOR Trial. Please recommend our study to others you feel would be interested. Researchers at Virginia Commonwealth University are exploring many different areas of low back pain. We would be happy to discuss The VIGOR Trial with you further. You may contact us at MCL@vcu.edu.
Are you 18 years of age or older?
* must provide value
Yes
No
You have indicated you are NOT at least 18 years of age. If you are NOT 18 you may not legally consent to answer the prescreen questions or participate in our study. We welcome you to inquire about The VIGOR Trial again when you are 18 years of age or older. Thank you.
Please provide your initials:
(Example: John Paul Smith = JPS)
* must provide value
Email address
* must provide value
Phone
* must provide value
Date of birth
* must provide value
Today Y-M-D Format: Year-Month-Day
Sex assigned at birth
* must provide value
Male
Female
Intersex or Indeterminate
What is your height?
* must provide value
4-feet 4-feet 1-inch 4-feet 2-inch 4-feet 3-inch 4-feet 4-inch 4-feet 5-inch 4-feet 6-inch 4-feet 7-inch 4-feet 8-inch 4-feet 9-inch 4-feet 10-inch 4-feet 11-inch 5-feet 5-feet 1-inch 5-feet 2-inch 5-feet 3-inch 5-feet 4-inch 5-feet 5-inch 5-feet 6-inch 5-feet 7-inch 5-feet 8-inch 5-feet 9-inch 5-feet 10-inch 5-feet 11-inch 6-feet 6-feet 1-inch 6-feet 2-inch 6-feet 3-inch 6-feet 4-inch 6-feet 5-inch 6-feet 6-inch 6-feet 7-inch 6-feet 8-inch 6-feet 9-inch 6-feet 10-inch 6-feet 11-inch 7-feet 7-feet 1-inch 7-feet 2-inch 7-feet 3-inch 7-feet 4-inch 7-feet 5-inch 7-feet 6-inch 7-feet 7-inch 7-feet 8-inch 7-feet 9-inch 7-feet 10-inch 7-feet 11-inch
What is your weight? (pounds)
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What is the race with which you most closely identify? (Select all that apply)
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What is the ethnicity with which you most closely identify?
* must provide value
Hispanic or Latino
Not Hispanic or Latino
How did you hear about The VIGOR Trial?
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If other, please describe:
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Have you had low back pain that has been ongoing at least half of the days in the last 6 months?
* must provide value
Yes
No
Directions: Please read each of the following statements and select the answer that best represents your feelings.
Are you involved in pending litigation related to an episode of low back pain
Yes
No
Have you had any of the following medical conditions?
Congestive heart failure
Heart attack
Multiple Sclerosis
Stroke Osteonecrosis
Severe osteoarthritis
Alzheimer's Disease
Amyotrophic Lateral Sclerosis
Parkinson's Disease
Rheumatoid Arthritis
Avascular necrosis
Broken spine
Spine surgery
Hip arthroplasty
Seizure
* must provide value
Yes
No
Are you currently...?
Blind
Have a significant visual impairment that would prevent virtual reality headset use
Pregnant (or anticipate becoming pregnant in the next 2-months)
Lactating
Diagnosed with active cancer
Yes
No
Over the past 10-years have you been nauseated or vomited due to the following activities?
Never
Rarely
Sometimes
Frequently
Always
Buses/Coaches
* must provide value
Never
Rarely
Sometimes
Frequently
Always
Boats
* must provide value
Never
Rarely
Sometimes
Frequently
Always
Roller Coasters
* must provide value
Never
Rarely
Sometimes
Frequently
Always
Select the number that best describes your average back pain over the past 7 days.
* must provide value
0 No Pain
1
2
3
4
5
6
7
8
9
10 Pain as bad as you can imagine
Select the number that best describes your average back pain over the past 24-hours.
* must provide value
0 No Pain
1
2
3
4
5
6
7
8
9
10 Pain as bad as you can imagine
Directions: When your back hurts, you may find it difficult to do some of the things you normally do. Listed below are some sentences that others have used to describe themselves when they have back pain. When you read them, you may find that some stand out because they describe you today. As you read the list, think of yourself today. When you read a sentence that describes you today, select YES. If the sentence does not describe you today, select NO. Remember, only answer YES if you are sure the sentence describes you today.
I stay at home most of the time because of my back
* must provide value
Yes No
I change positions frequently to try to get my back comfortable
* must provide value
Yes No
I walk more slowly than usual because of my back
* must provide value
Yes No
Because of my back, I am not doing any of the jobs I usually do around the house
* must provide value
Yes No
Because of my back, I use a handrail to get upstairs
* must provide value
Yes No
Because of my back, I lie down to rest more often
* must provide value
Yes No
Because of my back, I have to hold on to something to get out of an easy chair
* must provide value
Yes No
Because of my back, I try to get other people to do things for me
* must provide value
Yes No
I get dressed more slowly than usual because of my back
* must provide value
Yes No
I can only stand up for short periods of time because of my back
* must provide value
Yes No
Because of my back, I try not to bend or kneel down
* must provide value
Yes No
I find it difficult to get out of a chair because of my back
* must provide value
Yes No
My back is painful almost all of the time
* must provide value
Yes No
I find it difficult to turn over in bed because of my back
* must provide value
Yes No
My appetite is not very good because of my back pain
* must provide value
Yes No
I have trouble putting on my socks (or stockings) because of the pain in my back
* must provide value
Yes No
I only walk short distances because of my back pain
* must provide value
Yes No
I sleep less well because of my back
* must provide value
Yes No
Because of my back pain, I get dressed with help from someone else
* must provide value
Yes No
I sit down for most of the day because of my back
* must provide value
Yes No
I avoid heavy jobs around the house because of my back
* must provide value
Yes No
Because of my back pain, I am more irritable and bad tempered with people than usual
* must provide value
Yes No
Because of my back, I go upstairs more slowly than usual
* must provide value
Yes No
I stay in bed most of the time because of my back
* must provide value
Yes No