Screening Questionnaire for Pain Study (POP2)

INTRODUCTION

Welcome!  We're delighted that you are interested in participating an Omneuron clinical trial.  We appreciate your time.  Please read the information on this page, and fill out the information below, which should only take about 5-10 minutes.  Thank you.

If you would like more information about this study and what we do, please click here.

In order to determine whether you are eligible to participate in our current Chronic Pain treatment clinical trial,this website asks you questions about your pain condition, psychological factors, and medication usage.  There are no right or wrong answers.  We are selecting subjects to participate in our clinical trial based upon answers to these questions, for example, selecting subjects for a group with more severe or with less severe problems.  All of the data that is collected in this questionnaire will be destroyed if you are ineligible -- it is being collected to determine whether you are eligible to participate in the study. 

The following section contains  more detailed information about this study, time requirements, & potential risks and benefits. After this outline are the eligibility questions. All questions need a response to complete the screening. eligibility questions. It should take 5-10 minutes to finish. If you have any questions regarding the study or this eligibility screening from, please contact me directly.

All the best,

 Ella Laramee

Research Associate II

P (650) 585-5304

elaramee@omneuron.com

Study Information

Goal:

The goal of this neuroimaging study is to apply functional Magnetic Resonance Imaging (MRI) to study brain activation of people with chronic pain.  In this study, you will undergo several MRIs and perform mental tasks while you receive real-time fMRI feedback of your own brain activation.  You will see the activation in the form of a virtual reality interface.  This study allows us to learn if you can learn greater control of specific regions of the brain that are related to your pain experience.  We’ll then see if there are any corresponding changes in the pain you feel.

MRI

MRI uses a very strong magnet in order to take pictures of the structures and function inside your brain.  It will require you to go inside a narrow tube for about an hour at a time.  During this entire time, you’ll need to stay very still.  The MRI machine will make loud banging noises, so we’ll have you wear earplugs to cut down on the noise.     

We will need to confirm that you have a verifiable diagnosis for your pain condition.  Your diagnosis will need to be confirmed by your doctor in the form of either a medical record or letter dated within the last 12 months.  The medical records can either be faxed or mailed or brought in with you to our office only after you have been determined eligible to be a participant in the study and after you have signed the consent form. 

Time Commitment:

We will ask that you visit our office in Menlo Park, CA 12 times for this study.  10 of the sessions will be about 1 times per week and the final 2 are follow-up visits at 2 months and 6 months.  Each session will take about 2 hours to complete.  Each session will include filling out questionnaires and preparing you for study tasks. 6 sessions will involve getting an MRI. We want to allow enough time to answer any questions you have so that your whole time here is more interesting and comfortable.  Generally, the scan appointments will take place between 3:30pm to 9:30pm on weekdays, and/or on weekend day times.  We will try to work with you to schedule the best appointment times for you.  Your participation in this study is entirely voluntary.  If you decide to participate, you are free to withdraw your consent and to discontinue participation at any time.

Benefits:

We cannot promise any clinical benefit to you from undergoing this procedure.  Some patients have experienced decreases in their pain, but this is an investigational procedure so you should not presume that you would experience an improvement, and your pain could worsen. We do believe that the experience of undergoing an MRI and learning about these new techniques is interesting and enlightening.  Additionally, you will be contributing to the research process of potentially developing a future treatment for chronic pain.  For your time and inconvenience, you will be paid $25/hour for the MRI portions of the study and $10/hour for all other times related to the study.

Risks:

We are very concerned about your safety and for this reason, we will ask you questions designed to assess whether you can safely and comfortably participate in this study.  The MRI scanner uses a very powerful magnet that will forcefully attract certain metals.  We will ask you detailed questions about whether you have any non-removable metal in your body which might be attracted to the magnet and thus put you at risk.  If there is any uncertainty, we might ask you to obtain additional information from your physician as a precondition for participation in our study.  We cannot talk to your physician unless we have your permission.  If you have a fear of enclosed places or pain that might prevent you from laying flat for an hour, we may also ask you not to participate in this study. 

 (If Female) If you are pregnant or expecting to become pregnant we will ask that you not participate in this study because the effects of MRI on a fetus are unknown.  If you are of child-bearing age, we will ask you to take a pregnancy test at the beginning of the study and use approved birth control methods throughout the study.

 We will use the screening information obtained only to determine whether you are able to participate in our study and will otherwise keep all records confidential.  Please realize that if you choose to participate in the study, you may discontinue the scan at anytime. 

 We need to ask you questions about your health in general, and about any potential brain disorders such as learning disabilities, stroke or related risk factors, or severe mental illness.  As with the safety questions, this information will be used only to decide whether you are appropriate for our studies and will be kept confidential.

INSTRUCTIONS

This will take about 5-10 minutes to complete.  When you have finished answering ALL of the questions, please hit the submit button at the bottom of the page.  Please answer all of the following questions. If you leave any questions blank, you will not be eligible for the study.  You will not be able to save your results part-way through, only to submit the completed form.

Contact Information

First Name

Last Name

Phone (xxx) xxx-xxxx

Email Address (we will use this only to contact you regarding research study entry)

Chronic Pain Eligibility Pre-Screen

1. How did you find out about this research study?
Craigslist.com spineuniverse.com KDFC Radio KLIV Radio KRTY Radio The San Francisco Examiner backpage.com CenterWatch Clinical Connection Clinicaltrials.gov Meetup.com Fogster.com drugs.com The Metro The SF Weekly Mercury News (San Jose) San Francisco Bay Guardian Palo Alto Weekly Mountain View Voice Brochure Omneuron.com Discovery Channel TED Talks
If Other - please write in:

2. Have you been diagnosed with a Chronic Pain condition for 6 months or longer?
1. Yes 2. No

3. Are you between 21-60 years of age?
1. Yes 2. No

4. Do you weigh less than 220 lbs?
1. Yes 2. No

5. Are you claustrophobic?
1. No 2. Yes

6. Do you have cochlear implants, ear tubes, hearing aids, a pace maker, or spinal stimulator?
1. No 2. Yes

7. Are you able to commit to 12 visits to our office in Menlo Park, CA, where 6 of those visits will involve time in an MRI Scanner?
1. Yes 2. No

8. Have you ever had an MRI?
1. Yes 2. No

9. Have you been diagnosed with a psychiatric illness, stroke or learning disability?
No diagnoses Yes - depression Yes - Other psychiatric diagnoses Yes - Stroke Yes - Learning Disability

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SOAPR-R

You are about 2/4 done...

In the past 30 days.....


1. How often do you have mood swings?
0. Never 1. Rarely 2. Sometimes 3. Often 4. Always

2. How often have you feel a need for higher doses of medication to treat your pain?
0. Never 1. Rarely 2. Sometimes 3. Often 4. Always

3. How often have you felt impatient with your doctors?
0. Never 1. Rarely 2. Sometimes 3. Often 4. Always

4. How often have you felt that things are just too overwhelming that you can't handle them?
0. Never 1. Rarely 2. Sometimes 3. Often 4. Always

5. How often is there tension in the home?
0. Never 1. Rarely 2. Sometimes 3. Often 4. Always

6. How often have you counted pain pills to see how many are remaining?
0. Never 1. Rarely 2. Sometimes 3. Often 4. Always

7. How often have you been concerned that people will judge you for taking pain medication?
0. Never 1. Rarely 2. Sometimes 3. Often 4. Always

8. How often do you feel bored?
0. Never 1. Rarely 2. Sometimes 3. Often 4. Always

9. How often have you taken more pain medication than you were supposed to?
0. Never 1. Rarely 2. Sometimes 3. Often 4. Always

10. How often are you worried about being left alone?
0. Never 1. Rarely 2. Sometimes 3. Often 4. Always

11. How often have you felt a craving for medication?
0. Never 1. Rarely 2. Sometimes 3. Often 4. Always

12.  How often have others expressed concern over your use of medication?
0. Never 1. Rarely 2. Sometimes 3. Often 4. Always

13.  How often have any of your close friends had a problem with alcohol or drugs?
0. Never 1. Rarely 2. Sometimes 3. Often 4. Always

14. How often have others told you that you had a bad temper?
0. Never 1. Rarely 2. Sometimes 3. Often 4. Always

15. How often have you felt consumed by the need to get pain medication?
0. Never 1. Rarely 2. Sometimes 3. Often 4. Always

16. How often have you run out of pain medication early?
0. Never 1. Rarely 2. Sometimes 3. Often 4. Always

17. How often have others kept you from what you deserve?
0. Never 1. Rarely 2. Sometimes 3. Often 4. Always

18. How often, in your lifetime, have you had legal problems or been arrested?
0. Never 1. Rarely 2. Sometimes 3. Often 4. Always

19. How often have you attended an AA or NA meeting?
0. Never 1. Rarely 2. Sometimes 3. Often 4. Always

20.  How often have you been in an argument that was so out of control that someone got hurt?
0. Never 1. Rarely 2. Sometimes 3. Often 4. Always

21.  How often have you been sexually abused?
0. Never 1. Rarely 2. Sometimes 3. Often 4. Always

22. How often have others suggested that you had a drug or alcohol problem?
0. Never 1. Rarely 2. Sometimes 3. Often 4. Always

23. How often have you had to borrow pain medications from your family or friends?
0. Never 1. Rarely 2. Sometimes 3. Often 4. Always

24. How often have you been treated for an alcohol or drug problem?
0. Never 1. Rarely 2. Sometimes 3. Often 4. Always

COMM

Your are about 3/4 done...

Please answer each question as honestly as possible.  Keep in mind that we are only asking about the past 30 days.  There are no right or wrong answers.  If you are unsure about how to answer the question, please give the best answer you can.

1. In the past 30 days, how often have you had trouble with thinking clearly or had memory problems?
0. Never 1. Seldom 2. Sometimes 3. Often 4. Very often

2. In the past 30 days, how often do people complain that you are not completing necessary tasks? (i.e., doing things that need to be done, such as doing to class, work or appointments)?
0. Never 1. Seldom 2. Sometimes 3. Often 4. Very often

3. In the past 30 days, how often have you had to go to someone other than your prescribing physician to get sufficient pain relief from medications? (i.e. another Doctor, Emergency Room, friends, street sources)
0. Never 1. Seldom 2. Sometimes 3. Often 4. Very often

4. In the past 30 days, how often have you taken your medications differently from how they are prescribed?
0. Never 1. Seldom 2. Sometimes 3. Often 4. Very often

5. In the past 30 days, how often have you seriously thought about hurting yourself?
0. Never 1. Seldom 2. Sometimes 3. Often 4. Very often

6. In the past 30 days, how much of your time was spent thinking about opioid medications (having enough, taking them, dosing schedule, etc.)
0. Never 1. Seldom 2. Sometimes 3. Often 4. Very often

7. In the past 30 days, how often have you been in an argument?
0. Never 1. Seldom 2. Sometimes 3. Often 4. Very often

8. In the past 30 days, how often have you had trouble controlling your anger (e.g. road rage, screaming, etc.)?
0. Never 1. Seldom 2. Sometimes 3. Often 4. Very often

9. In the past 30 days, how often have you needed to take pain medications belonging to someone else?
0. Never 1. Seldom 2. Sometimes 3. Often 4. Very often

10. In the past 30 days, how often have you been worried about how you're handling your medications?
0. Never 1. Seldom 2. Sometimes 3. Often 4. Very often

11. In the past 30 days, how often have others been worried about how you're handling your medications?
0. Never 1. Seldom 2. Sometimes 3. Often 4. Very often

12. In the past 30 days, how often have you had to make an emergency phone call or show up at the clinic without an appointment?
0. Never 1. Seldom 2. Sometimes 3. Often 4. Very often

13. In the past 30 days, how often have you gotten angry with people?
0. Never 1. Seldom 2. Sometimes 3. Often 4. Very often

14. In the past 30 days, how often have you had to take more of your medication than prescribed?
0. Never 1. Seldom 2. Sometimes 3. Often 4. Very often

15. In the past 30 days, how often have you borrowed pain medication from someone else?
0. Never 1. Seldom 2. Sometimes 3. Often 4. Very often

16. In the past 30 days, how often have you used your pain medicine for symptoms other than for pain (e.g. to help you sleep, improve your mood, or relieve stress)
0. Never 1. Seldom 2. Sometimes 3. Often 4. Very often

17. In the past 30 days, how often have had to visit the Emergency Room?
0. Never 1. Seldom 2. Sometimes 3. Often 4. Very often

Medications

You are almost finished...

Last Question.
For inclusion in the study, it is very important that we know what medications you have been or are currently prescribed for pain.  Please look through the list below, and be sure to select any/all of the pain medications that  you have EVER been prescribed or have taken:

Hydocodone- brand names include: Vicodin, Symtan, Anexsia, Dicodid, Hycodan (or generically Hydromet), Hycomine, Lorcet, Lortab, Norco, Novahistex, Hydroco, Tussionex, Gentex, Vicoprofen, Xodol, Bekadid, Calmodid, Codinovo, Duodin, Kolikodol, Orthoxycol, Mercodinone, Synkonin, Norgan, and Hydrokon             Dihydrocodeine- brand names include: DHC, Drocode, Paracodeine & Parzone; brand names of Synalgos DC, Panlor DC, Panlor SS,   Contugesic, SS Bron, Drocode, Paracodin, Codidol, Didor Continus, Dicogesic, Codhydrine, Dekacodin, DH-Codeine, Didrate, Dihydrin, Hydrocodin, Nadeine, Novicodin, Rapacodin, Rikodeine,Fortuss, Remedeine, Dico, & DF-118  methadone                                           fentanyl: Actiq  propoxyphene: Darvon  heroin/diacetylmorphine                     codeine: Fiorinal                                   morphine: Avinza  tramadol: Ultram  meperidine/pethidine: Demerol  oxymorphone: Opana/Numorphan/Numorphone        oxycodone: OxyContin/Percodan/Percocet  buprenorphine: Subutex/Subuxone  hydromorphone/dihydromorphinone: Palladone/Dilaudid

Other medications -- please enter full name(s) for other pain medications you are taking that are not shown above.


Problems with this form -- please let us know if you had any problems with filling out this form.  We can improve it in the future based on people's comments.  Thanks again!

When you have selected an answer to EVERY question above, please hit the button below.  You will not be eligible for the study unless you have answered every question.

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