Screening

Please complete the survey below.

Thank you!

Date

* must provide value

M-D-Y

Select the study site closes to you:

University of Florida

Penn State University

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Hello, my name is _________, you are receiving this telephone call because you requested information about the SRD pain study that is being conducted at the University of Florida.

Telephone Voicemail Message Script

Hello, my name is _________ and I am _________ calling from the University of Florida to speak to _________ about a research study. Please contact us at 352-273-6441. We appreciate your consideration of our research study and hope to hear from you soon.

If someone other than the potential participant answers the telephone, use the script below

Hello, my name is _________ and I am _________ calling from the University of Florida to speak to _________. Could you please pass along my contact information to _________? [If person on the telephone says yes to passing on the message]. The telephone number is 352-273-6441. Thank you for your time.

Phone Script for contacting potential subjects obtained from the Consent2Share

Hello, my name is _________ and I am _________ calling from the University of Florida. I am contacting you to see if you are interested in participating in a research study that assesses factors influencing pain perception in adults with pain. During a past clinic visit, you signed a consent form telling us you were interested in being contacted for future research that you might qualify for.

Hello, my name is _________, you are receiving this telephone call because you requested information about the SRD pain study that is being conducted at Penn State University.

Telephone Voicemail Message Script

Hello, my name is _________ and I am _________ calling from Penn State University to speak to _________ about a research study. Please contact us at (814) 865-0800. We appreciate your consideration of our research study and hope to hear from you soon.

If someone other than the potential participant answers the telephone, use the script below

Hello, my name is _________ and I am _________ calling from Penn State University to speak to_________. Could you please pass along my contact information to _________? [If person on the telephone says yes to passing on the message]. The telephone number is (814) 865-0800. Thank you for your time.

Phone Script for contacting potential subjects obtained from the Consent2Share Process, TrinetX, studyfinder, ACT

Hello, my name is _________ and I am _________ calling from Penn State University. I am contacting you to see if you are interested in participating in a research study that assesses factors influencing pain perception in adults with pain. During a past clinic visit, you signed a consent form telling us you were interested in being contacted for future research that you might qualify for.

Are you interested in hearing more about this research study on persons with pain?

If no, thank them for their time.

If yes, proceed with study description.

Not interested

Yes, interested

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Thank you for your time. Have a nice day!

(If yes, proceed with study description)

This study is trying to understand more about factors that cause pain in people who have had stressful experiences. In order to find out if you might be eligible to be in the study, we would like to ask you some questions about yourself. These questions include information about you, such as your date of birth, gender, and race, but we will also be asking questions about your medical health. Your answers to these questions will help us know whether you are eligible to be in the study. If there are any questions you don't want to answer, you can tell me, and we will skip to the next question.

Also, if you have neurological diseases, such as Parkinson's, Multiple Sclerosis, epilepsy, if you have been hospitalized for mental health reasons in the past year, or current substance use disorder or a history of hospitalization for treatment of substance use disorder you will not be able to be in the study. Based on this information would it be alright for me to ask you some questions or are you no longer interested in the study? If you do not participate in the study, we will remove all identifying information.

Are you still interested in the study?

Yes

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Thank you for your time. Have a nice day!

(If interested)

I'll start with telling you about the study:

In this study, we will ask you to make two visits to our research clinic at the University of Florida, both visits will last up to 3 hours. Before your visit, we will send a copy of the informed consent form at least 24 hours before your first appointment, for you to review. However, you can request additional time to review the form. Before each visit, we will ask you to complete some questionnaires, either on paper or online.

During the clinic visits we will do:

1. A review of the Informed Consent form with you to make sure that you understand everything that is involved in the study

2. A medical history, including a urine pregnancy test in women of childbearing potential

3. Some tests of your strength and function

4. We will ask you to complete several questionnaires about your health, your thoughts about pain, and how you think and feel about things. We will ask some personal questions, because this will help us know about all of the things that might be affecting your symptoms of pain.

5. A series of brain imaging tests

6. During one of the sessions we will take some blood samples to measure chemicals that might be related to your pain.

7. Some sensory tests to see how you feel painful and non-painful sensations.

8. During the sensory, functional, and MRI tests we may take videos or photos and vital signs using some wires attached to your fingers and chest.

Possible discomforts and risks to you:

1) The pain testing procedures may be uncomfortable or unpleasant. You will experience some temporary discomfort from the heat, pressure, cold, and mechanical pain testing. Your blood pressure may increase following pain testing. However, if you feel the pain is greater than you wish to tolerate, you can stop any of the procedures at any time;

2) the risks of drawing blood from a vein include discomfort at the site of puncture; possible bruising and swelling around the puncture site; rarely, an infection; and, uncommonly, faintness from the procedure. We reduce these risks by using sterile needles, alcohol scrub, applying pressure to your arm after we remove the needle, and using a trained technician or nurse experienced in collecting research blood draws;

3) the activity tests may produce discomfort, and you can stop these procedures at any time;

4) there is not much room inside the MRI scanner. You may be uncomfortable if you do not like to be in close spaces or if you are claustrophobic. During the procedure, you will be able to talk with the MRI staff through a speaker system, and in the event of an emergency, you can tell them to stop the scan. The MRI scanner produces a loud hammering noise, which has produced hearing loss in a very small number of patients not using hearing protection. You will be given earplugs to reduce this risk;

5) if you are a woman of childbearing potential, there may be unknown risks to the fetus. Therefore, before you can have the MRI, you must have a pregnancy test in order to rule out that you are pregnant;

6) other possible risks to you may include: You may feel uncomfortable about answering some of the questions on the questionnaires. You do not have to answer those questions; and

7) there is a risk of loss of confidentiality if your information or your identity is obtained by unauthorized person(s).

Potential Benefits to you:

There may or may not be direct benefit to you; however, a better understanding of how stressful experiences impact chronic pain-related outcomes has the potential for substantial societal benefit.

Compensation:

You will be paid for your participation in this study. The total amount you will be paid for completing all study procedures over the two-day period is $175, and you will receive partial payment if you do not complete the entire study. Participants will be paid $25 for transportation.

Screening success or failure:

1) If you qualify to participate in the study, we will keep the information you provide in addition to information you provide to these questions as part of this research study.

(If interested)

I'll start with telling you about the study:

In this study, we will ask you to make two visits to our research clinic at Penn State University, both visits will last up to 3 hours. Before your visit, we will send a copy of the informed consent form at least 24 hours before your first appointment, for you to review. However, you can request additional time to review the form. Before each visit, we will ask you to complete some questionnaires, either on paper or online.

During the clinic visits we will do:

1. A review of the Informed Consent form with you to make sure that you understand everything that is involved in the study

2. A medical history, including a urine pregnancy test in women of childbearing potential

3. Some tests of your strength and function

5. A series of brain imaging tests

6. During one of the sessions we will take some blood samples to measure chemicals that might be related to your pain.

7. Some sensory tests to see how you feel painful and non-painful sensations.

8. During the sensory, functional, and MRI tests we may take videos or photos and vital signs using some wires attached to your fingers and chest.

9. We may ask you to use a device like a smartwatch that measures your sleep, activity and some of your vital signs and report pain and other experiences outside of the clinic visit.

Possible discomforts and risks to you:

3) the activity tests may produce discomfort, and you can stop these procedures at any time;

6) other possible risks to you may include: You may feel uncomfortable about answering some of the questions on the questionnaires. You do not have to answer those questions; and

7) there is a risk of loss of confidentiality if your information or your identity is obtained by unauthorized person(s).

Potential Benefits to you:

There may or may not be direct benefit to you; however, a better understanding of how stressful experiences impact chronic pain-related outcomes has the potential for substantial societal benefit.

Compensation:

Screening success or failure:

1) If you qualify to participate in the study, we will keep the information you provide in addition to information you provide to these questions as part of this research study.

Are you still interested in the study?

Yes

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Thank you for your time. Have a nice day!

Thank you for your interest in the research study called SRD Study that is being conducted at the University of Florida. This study is trying to understand more about factors that cause pain in people who have had stressful experiences.

Study participation will include two 3-hour laboratory sessions in which responses during pain sensation testing and brain imaging are assessed.

Procedures for Visit 1
The following procedures will be done during the different clinic visits:

A. Review Informed Consent.

B. Physical measurements. (e.g., height, weight).

C. Medical and Pain History. Answer questions about your medical history including past and present health conditions and treatments.

D. Blood collection.

E. Questionnaires. Complete questionnaires.

F. Physical Performance Tests. (e.g. standing still, walking test).

G. Pain sensation testing:

• Heat pain tests: Heat will be applied to different parts of your body. The amount of heat will be controlled by a computer with safety limits of time and temperature. You can stop the testing at any time, so that you do not experience pain you find unacceptable.

• Pressure Pain Tests. We will use a small rubber tip to apply pressure to different parts of your body. The pressure will be slowly increased. You will tell the examiner when you begin to feel pain. As soon as you tell us you feel pain, the pressure will be removed.

• Mechanical Pain Tests. We will use a small nylon tip to tap on different parts of your body. We will ask you to tell us how painful this feels.

• Combined Pressure and Cold Tests. You will immerse your hand in a cold-water bath and we will apply pressure before and after you put your hand in cold water. We will ask you to report when you feel pain.

Procedures for Visit 2

A. Brain Magnetic Resonance Imaging (MRI). We will take pictures of your brain using MRI. The MRI portion will take up to 60 minutes to complete.

B. Questionnaires. Complete questionnaires.

Compensation: You will be paid for your participation in this study. The total amount you will be paid for completing all study procedures over the two-day period is $175, and you will receive partial payment if you do not complete the entire study. [When this option is available: you will be paid an additional $50 if you agree to wear the device like a smartwatch between visits].

Thank you for your interest in the research study called SRD Study that is being conducted at Penn State Milton S. Hershey Medical Center. This study is trying to understand more about factors that cause pain in people who have had stressful experiences.

Study participation will include two 3-hour laboratory sessions in which responses during pain sensation testing and brain imaging are assessed.

Procedures for Visit 1
The following procedures will be done during the different clinic visits:

A. Review Informed Consent.

B. Physical measurements. (e.g., height, weight).

C. Medical and Pain History. Answer questions about your medical history including past and present health conditions and treatments.

D. Blood collection.

E. Questionnaires. Complete questionnaires.

F. Physical Performance Tests. (e.g. standing still, walking test).

G. Pain sensation testing:

• Pressure Pain Tests: We will use a small rubber tip to apply pressure to different parts of your body. The pressure will be slowly increased. You will tell the examiner when you begin to feel pain. As soon as you tell us you feel pain, the pressure will be removed.

• Mechanical Pain Tests: We will use a small nylon tip to tap on different parts of your body. We will ask you to tell us how painful this feels.

Procedures for Visit 2

A. Brain Magnetic Resonance Imaging (MRI). We will take pictures of your brain using MRI. The MRI portion will take up to 60 minutes to complete.

B. Questionnaires. Complete questionnaires.

Compensation: You will be paid for your participation in this study. The total amount you will be paid for completing all study procedures over the two-day period is $175, and you will receive partial payment if you do not complete the entire study. [When this option is available: you will be paid an additional $50 if you agree to wear the device like a smartwatch between visits].

Would you be willing to be part of this study?

Yes

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Thank you for your time. Have a nice day!

Thank you for taking the time to complete this screening. In order to determine if you qualify to be in the study, you will be asked personal questions such as your date of birth, gender, and race, but you will also be asked questions about your medical health. Your participation is completely voluntary and you do not have to answer any questions if you do not want to.

1) If you qualify to participate in the study, we will keep the information you provide in addition to information you provide to these questions as part of this research study.

2) If you do not participate in the study, we will keep the information you provide, but we will remove all identifying information, so that our study team will not be able to link the health information back to you.
Also, if you have neurological diseases, such as Parkinson's, Multiple Sclerosis, epilepsy, if you have been hospitalized for mental health reasons in the past year, or current substance use disorder or a history of hospitalization for treatment of substance use disorder, you will not be able to be in the study.

Are you willing to proceed with the screening?

Yes

I would prefer to answer the questions over the phone

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Thank you for your time. Have a nice day!

Please exit this form and call us at (352)-273-6441 to answer the screening questions over the telephone.

Please exit this form and call us at (814) 865-0800 to answer the screening questions over the telephone.

First Name:

* must provide value

Last Name:

* must provide value

Phone Number:

* must provide value

What is your age?

Thank you very much for taking the time to answer these questions. Unfortunately, according to our protocol, we cannot include you in our study. We appreciate your helpful participation in this screening. Do you have any questions?

What sex were you assigned at birth, on your original birth certificate?

* must provide value

Female

Male

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What is your current gender? (Mark only one)

* must provide value

Female

Male

Transgender

I use a different term [specify below]

Don't Know

Prefer not to answer

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Different gender term

* must provide value

Race

Asian or Asian American

Black or African American

White, Caucasian, or European

American Indian or Alaska Native

Native Hawaiian or Other Pacific Islander

Some Other Race or Origin (Specify below)

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Specify Other race here:

Ethnicity

Hispanic or Latino

Not Hispanic or Latino

Unknown/Unanswered

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How did you hear about our study?

Flyer/advertisement

Referred by friend or family member

From another researcher

Referred by health care provider

Recruited from clinic

At a community event (e.g. health fair)

Consent2Share

BuildClinical

Social media ad

Other (specify below)

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How did you hear about our study?

Flyer/advertisement

Referred by friend or family member

From another researcher

Referred by health care provider

Recruited from clinic

At a community event (e.g. health fair)

Consent2Share

TrinetX

Studyfinder

Accrual to Clinical Trials (ACT)

BuildClinical

Social media ad

Other (specify below)

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Specify Other way they heard about study:

1. During the past 3 months, have you had pain on most days in your muscle or joint?

Yes

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1a. If yes, which site is the most painful?

Knee

Lower back

Other

Multiple sites

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Specify Other

1a(i). Is your knee one of your most painful sites?

Yes

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1a(ii). Is your lower back one of your most painful sites?

Yes

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1b. If yes, what is the average severity of your pain, in the site that is the most painful? (0-10)

0 (no pain)

10 (most intense pain imaginable)

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2. Do you have a chronic pain diagnosis, in the site that is the most painful?

Yes

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2a. If yes, who provided you with the diagnosis?

General Practitioner

Rheumatologist

Orthopedic Doctor

Other

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Other

2b. If yes, what is your chronic pain diagnosis in the site that is the most painful?

3. Do you have a history of clinically significant surgery to the body site that is the most painful (e.g. open reconstruction, joint replacement)?

Yes

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3a. If yes, which knee?

Left knee

Right knee

Both knees

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3a. If yes, which part of your lower back?

Left lower back

Right lower back

Backbone (L1-L5)

Whole lower back

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3b. Please describe the surgery

3c. On the knee that is the most painful, do you have a large surgical scar?

* must provide value

Yes

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3d. Do you have pain in your other knee?

* must provide value

Yes

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3c. Was the back surgery within the past 6 months?

* must provide value

Yes

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3d. In general, what date was the most recent surgery?

M-D-Y

3d. In general, what date was the most recent surgery?

Not applicable

3e. In general, what date was the most recent surgery?

M-D-Y

3e. In general, what date was the most recent surgery?

Not applicable

3f. Have you had an injection?

Yes

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3f.(a) If yes, what type of injection?

Cortisone

Epidural injection

Steroid injection

Other

3f.(a) What other type(s) of injection(s)?

3f.(b) If yes, which body site(s) was injected?

3f.(c) If yes, what date was the most recent injection?

M-D-Y

Date 6 weeks after surgery when 1st appointment can be scheduled

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Date 6 weeks after surgery when 1st appointment can be scheduled

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Date 6 weeks after injection when 1st appointment can be scheduled

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4. Have you ever been diagnosed with rheumatoid arthritis?

Yes

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5. Do you have uncontrolled high blood pressure?

Yes

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5a. If yes, is it usually higher than 150/95?

Yes

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6. Do you have a history of heart disease or heart procedure?

Yes

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6a. Have you had any new chest pain, chest pressure, or shortness of breath over the past 30 days?

Yes

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6b. Have you had a heart attack or any type of heart procedure (surgery, stent) within the past 2 months?

Yes

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7. If female, are you currently pregnant or nursing/breastfeeding?

Yes

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8. Do you use pain medications every day?

Yes

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8a. If yes, what medications do you take daily for pain?

8b. Daily opioid use:

Yes

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9. Do you have problems with your circulation, such as very cold hands or feet, or numbness and tingling in your hands and feet? (e.g., diagnosis of peripheral neuropathy)

Yes

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A neuropathy diagnosis is always exclusionary.

If they don't have a neuropathy diagnosis, please collect information about the numbness/tingling and add to the comments:

Do they experience numbness or tingling or both?
Do they experience it in their hands or feet or both?
How often are they experiencing it?
When it happens, how long does it last?
Are there any activities they do that appear to trigger it?

For lower back participants:

Numbness/tingling in feet would not contraindicate pain testing

For knee participants:

Numbness/tingling in feet could contraindicate pain testing if it travels up their leg to their knee. Please ask about this and add to comments.

For all participants:

Numbness/tingling in hands needs to be assessed for suitability for CPM.

10. Do you currently have lupus?

Yes

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10a. Are you currently being treated for lupus?

Yes

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10b. If yes, what treatment are you receiving?

10c. Have you had a flare up in the last 2 months?

Yes

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10d. If yes, what date did your last lupus flare up end?

M-D-Y

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Date 2 months after gout flare up when 1st appointment can be scheduled

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11. Have you ever been diagnosed with gout?

Yes

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11a. Are you currently being treated for gout?

Yes

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11b. If yes, what treatment are you receiving?

11c. Have you had a flare up in the last 2 months?

Yes

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11d. If yes, what date did your last gout flare up end?

M-D-Y

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Date 2 months after gout flare up when 1st appointment can be scheduled

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12. Have you ever participated in a research study?

Yes

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12a. If so, are you currently enrolled in a research study?

Yes

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12b. If so, when does your current study end?

* must provide value

M-D-Y

13. Have you been diagnosed with a previous brain injury, including a stroke that resulted in noticeable changes or severe traumatic brain injury?

Yes

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13a. Do you have any physical disabilities that may affect your ability to participate in study procedures (for example, blindness or low vision, deafness or significant hearing loss, or use of a wheelchair or other mobility device)?

Yes

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14. Do you have any metal implants in your body (ex. surgical implants, permanent retainers, piercings, tattoos with metal, permanent make-up with metal, metal in hair or scalp that cannot be removed)?

Yes

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14a. If yes, describe:

14b. Is the metal implant MRI compatible material (e.g., Titanium, cobalt-chromium, stainless steel)?

Yes

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For safety reasons, you would not be able to complete the MRI for our study. We can continue the screening since you may still be able to complete all other study procedures. Do you have any questions?

15. Do closed spaces bother you?

Yes

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16. Have you experienced any problems related to a previous MRI examination or MRI procedure?

Yes

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17. Have you had an injury to the eye involving a metallic object or fragment (e.g., metallic slivers, shavings, foreign body, etc.)?

Yes

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18. Have you ever been injured by a metallic object or foreign body (e.g., BB, bullet, shrapnel, etc.)?

Yes

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19. Do you have an electronic implant or device (not including dentures)?

Yes

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20. Are you willing to give blood?

Yes

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20a. Do you have a history of experiencing problems during blood draw (e.g., fainting)?

Yes

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21. Were you born in the United States?

Yes

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21a. If no, did you arrive to the United States by the age of 14 years old?

Yes

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22. Weight

23. Height

23a. BMI

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Participant's BMI is over 50. They cannot complete MRI.

Thank you very much for taking the time to answer these questions. Based on your responses you meet initial eligibility criteria. Are you still interested in participating in this study?

Yes
No
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Thank you for your time. Have a nice day!

First Name

Last Name

Date of Birth

M-D-Y

Primary Phone Number

Additional Phone Number

Physical Address Line 1

Physical Address Line 2

City

State

Zip Code

Separate Mailing Address?

Check box to enter a separate mailing address

Mailing Address Line 1

Mailing Address Line 2

City

State

Zip Code

Email Address

Would you like to receive text message appointment reminders?

* must provide value

Yes

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If yes, which company provides service for your mobile device?

* must provide value

Specify other service provider:

* must provide value

Do you have time available to schedule a 3-hour visit to our testing center at the University of Florida?

Yes

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Do you have time available to schedule a 3-hour visit to our testing center at the Penn State Milton S. Hershey Medical Center?

Yes

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What is a good date and time to contact you to schedule your first clinic visit?

M-D-Y H:M

Thank you for completing the screening, a member of our team will be in contact with you to schedule the appointment at our testing center at the University of Florida.

Thank you for completing the screening, a member of our team will be in contact with you to schedule the appointment at our testing center at the Penn State Milton S. Hershey Medical Center.

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