Informed Consent for Study Participation
Key Information for the study named: Monitoring Adherence of people having chronic musculoskeletal pain to “frequency of use” instructions for home use of a muscle tension and control exercise over a two-week period.
This page is designed to give you key information to help you decide whether to participate. Detailed study information follows this page.
Please ask questions. If you have questions later, the contact information for the research investigator in charge of the study is below.
We are asking you to choose whether or not to volunteer for a research study about listening to a muscle tension awareness and control audio exercise for two weeks. You are being asked to participate because we are seeking volunteers who: (a) Have had muscle tension related low back pain for at least two years not treated with anything other than over the counter muscle relaxants/anti-inflammatories, (b) are at least 18 years of age, (c) Are available to listen to a 20 minute recorded relaxation exercise twice per day (once in the morning and once in the evening) for two weeks, (d) Have not have had a physician or other provider diagnose a mental problem as an adult of any kind including PTSD. (e) Have a computer or smartphone with internet service and your own email address, and (f) Not have any physical problems which could contribute to the pain other than muscle tension.
All of your contact with the investigators and participation is over the internet. If you decide to participate, you can stop at any time without having to give a reason.
WHAT IS THE STUDY ABOUT AND HOW LONG ARE YOU BEING ASKED TO PARTICIPATE? This study is finding out if people having muscle-related low back pain who are listening to a muscle tension awareness and control exercise use it as often as instructed. We hope to learn the use patterns of people asked to listen to a 20-minute audio twice per day for two weeks. Your participation in this study will total about 9 ½ hours if you listen the full amount. For a complete description of the study, refer to the Detailed Consent that follows. You can listen to a sample recording of the exercise by clicking http://www.behavmedfoundation.org/study-participation-audio-file/ before you decide whether or not to participate in the study.
WHAT ARE KEY REASONS YOU MIGHT CHOOSE TO VOLUNTEER FOR THIS STUDY? This exercise has been shown to be moderately effective in helping many people with muscle-related pain reduce the frequency and intensity of the pain when used as directed for this study. It’s possible that you may improve your ability to reduce your muscle tension related pain so experience fewer aches and pains. The benefits to others are that the information will show whether there are consistent usage patterns among people listening to these exercises. There are no known risks to participating in this study. For a complete description of benefits and/or rewards, refer to the Detailed Consent.
WHAT ARE KEY REASONS YOU MIGHT CHOOSE NOT TO VOLUNTEER FOR THIS STUDY? You may not wish to spend about 9 ½ hours listening to the exercise. There is no guarantee that the exercise will help you reduce your pain. There are no known risks to participating in this study. For a complete description of risks, refer to the Detailed Consent.
DO YOU HAVE TO TAKE PART IN THE STUDY? If you decide to take part in the study, it should be because you really want to volunteer. You will not lose any services, benefits, or rights you would normally have if you choose not to volunteer or if you choose to withdraw from the study for any reason.
WHAT IF YOU HAVE QUESTIONS, SUGGESTIONS, OR CONCERNS? The person in charge of this study is Dr. Richard Sherman (LTC US Army Ret), faculty in the Psychophysiology Department at Saybrook University. If you have questions, suggestions, or concerns regarding this study, please contact Dr. Sherman at https://ansr.me/VWv70 (This is a site that guarantees the anonymity of senders. You must check a box if you want a reply.) or Phone us at 1- 800 530 6658. You do not have to contact anybody if you decide to cease participation in the study. You simply stop. If you have any questions, suggestions, or concerns about your rights as a volunteer in this research, or if you are harmed in this research, contact the Saybrook Institutional Review Board (IRB) Office at 626-316-5380 or irb@saybrook.edu. For background information about the investigators, go to http://www.behavmedfoundation.org/study-participation-background/
DETAILED CONSENT For the Study Named:
Monitoring Adherence of people having chronic musculoskeletal pain
to “frequency of use” instructions for home use of a muscle tension and control exercise over a two-week period
ARE THERE REASONS WHY YOU WOULD NOT QUALIFY FOR THIS STUDY?
You would not qualify to participate in this study if you: (a) Have not had muscle tension related low back pain for at least two years. (b) Have muscle tension related back pain for at least two years but it is treated by anything other than over the counter muscle relaxants and anti-inflammatories. (c) Are not at least 18 years of age. (d) Are not available to listen to a 20 minute recorded relaxation exercise twice per day (once in the morning and once in the evening) for two weeks. (e) Have had a physician or other provider diagnose a mental problem as an adult of any kind including PTSD. (We won’t be checking any records or ask your physician – this is just by your self-report.) (f) Do not have a computer or smartphone with internet service and your own email address. (g) Have any physical problems which could contribute to the pain other than muscle tension.
WHERE WILL THE STUDY TAKE PLACE AND WHAT IS THE TOTAL AMOUNT OF TIME INVOLVED? The research will be conducted at your own home through your computer or smartphone. You will not need to meet with us in-person at any time.
You are being asked to listen to a recorded muscle tension awareness and control exercise twice per day for two weeks. Each of those listening times will take about 20 minutes. The total amount of time you will be asked to volunteer for this study is 9 ½ hours over the next two weeks.
WHAT WILL YOU BE ASKED TO DO? The 20 minute muscle tension awareness and control exercise is similar to those which have been on the market for decades. The exercise is from a program developed by Dr. Richard Sherman and has been in use with people having muscle related pain for over 20 years. It is intended to help people recognize how tense their muscles are so they do not remain tenser than needed during the day. You will tense one muscle group in your body at a time very slightly. You will recognize the feelings coming from your muscles, relax them and then notice the difference in feelings. These exercises are intended to help people not get as achy as they might from keeping their muscles tenser than needed. This study is not a treatment. We have no real idea whether listening to the exercise will help you in any way. Our interest is only in tracking your listening to the recording.
The research activities include:
- Learning about the study:
- Reading about the study on a web site: You may find this study by reading a web-based flyer describing the study. This should take about five minutes. The flyer contained links to a sample of the exercise and to the consent form so you had a chance to review both before making any contact with the investigators. Reading the consent form and listening to the exercise could take an additional 30 minutes.
- The flyer contains a link to an anonymous email drop and a unique phone number you can use to get further information about the study and arrange a private chat with one of the investigators. You should talk with one of the investigators so any questions you have about the study and consent form are answered and so we can ask you several screening questions noted below before you sign the Informed Consent. The discussion is likely to take about 15 minutes.
- Before you sign the consent form, we will ask you a series of screening questions to determine whether you meet the study’s entrance criteria. This should take about 5 minutes. The screening questions are:
Have you had muscle-related low back pain for at least two years? (If yes, you can participate.)
Are you 18 years of age or older? (If yes, you can participate.)
Are you available to listen to a 20-minute recorded muscle tension awareness and control exercise twice per day (once in the morning and once in the evening) for two weeks starting within a month of entering the study? (If yes, you can participate.)
Have you had a physician or other provider diagnose a mental problem as an adult of any kind including PTSD. (We won’t be checking any records or ask your physician – this is just by your self-report.)? (If yes, you can NOT participate.)
Do you have any medical problems other than muscle tension related low back pain which would cause pain? (If yes, you can NOT participate.)
Do you have a computer or smart phone with internet service and your own email address? (If yes, you can participate.)
Are you being treated for your pain with anything other than over the counter muscle relaxants? (If yes, you can NOT participate.)
- You will also be asked to describe and rate the intensity of your pain as you recall it for the last two weeks before and after participation in the study. This step should require about four minutes.
- If you want to participate in the study you may sign the Informed Consent document on-line and email it back to the investigators. This step could take about 2 minutes.
- Next Steps for Procedure:
- After you sign the Informed Consent, you will receive a link to a web site containing an introduction to the exercise program and to the exercise itself. It will take about 10 minutes to read the instructions.
- You can begin accessing the Self-Relaxation Audio through your computer or smartphone starting any morning within a month of receiving the instructions. You will be instructed to start by listening to the Introduction Audio contained in the email attachment. The Introduction Audio will take about 10 minutes to complete. The muscle tension awareness and control exercise can be accessed from your smart phone or computer by signing into the study’s web site using a unique identification number we will provide you with. Assuming that you play the approximate 20-minute exercise twice per day for two weeks, participation should take about 9 ½ hours. The website keeps track of each time you access the exercise.
NOTE: You must not listen to the exercise while driving as the exercise is too relaxing and distracting to permit safe driving!
- After you have used the exercise (to whatever amount) for 14 days in a row, the investigators will wait two weeks then send you an email (a) asking you to rate your pain intensity over the past two weeks and (b) letting you know that you have completed your participation. It will take about 5 minutes to read the email and respond with your rating. This is the information we will ask you for:
Two-Week Low-Back Pain Rating
You are being asked to rate your low back pain for the last two weeks as part of your participation in the study entitled: “Monitoring Adherence of people having chronic musculoskeletal pain to “frequency of use” instructions for home use of a muscle tension and control exercise over a two-week period.”
Individual identifying information will not be kept with this rating.
Over the past two weeks:
- For the past two weeks, about how many episodes of low back pain did you have? ___ (#)
- For the past two weeks, for about how many days did you have any low back pain? ____ (#)
- For the past two weeks, about how many episodes of debilitating low back pain did you have? ___ (#)
(By debilitating, we mean sufficient pain/spasms that you couldn’t do something you wanted to do.)
4.For the past two weeks, about how many days were you free of low back pain? ____ (#)
For the next three questions, please rate your pain on a scale of 0 to 10 where zero is no pain and ten is so much that you would faint if you had to stand it for one more second.
- Using the above scale, what number would you give to the worst episode of low-back pain you had over the last two weeks? ________ (#)
- About how many hours did the episode last for? _______ (hours)
- Using the above scale, what number would you give for the average low-back pain you have experienced over the last two weeks? ____ (#)
- After completing participation: if you want a copy of the full exercise series, the investigators will provide you with a link to it which you can download.
WHAT ARE THE POSSIBLE RISKS AND DISCOMFORTS? Participating in this study involves no expected risks or discomforts. You will be listening to the exercise on your own computer or smartphone. The exercise has never been reported to cause people any problems in over forty years of use. Even though there are no expected risks, it is always possible that you may experience a previously unknown effect. If you decide you don’t want to listen to the exercise for any reason, you can just stop. You never have to tell us why you stopped.
WILL YOU BENEFIT FROM TAKING PART IN THIS STUDY? We do not know if you will get any benefit from taking part in this study. However, many people doing similar exercises have experienced a reduction of muscle tension and therefore less minor aches and pains. If you take part in this study, information learned may help others. The potential benefit to others is that it will help determine whether there are consistent patterns a group of people show when and how often they listen to the exercise. This will permit other people to figure out how much use of this type of exercise results in helping people so people don’t have to listen to the exercise longer or more often than necessary to get an effect.
IF YOU DON’T WANT TO TAKE PART IN THE STUDY, ARE THERE OTHER CHOICES? If you do not want to take part in the study, your health care provider may suggest the use of other exercises and treatments.
WHAT WILL IT COST YOU TO PARTICIPATE? There are no costs associated with participating in this study other than your time.
WHO WILL SEE THE INFORMATION THAT YOU PROVIDE? When we write about or share the results from the study, we will write about information combined from all participants so there will be no way for anybody to know the details of your participation. We will keep your name and other identifying information private. The people who will have access to your individual information are: the principal and co-principal investigators (Richard Sherman, Emily Thomas, and Shelley Spencer-Hellmich) and a research assistant who signed a non-disclosure agreement. We will make every effort to prevent anyone who is not on the research team from knowing that you gave us information, or about the information you provide.
Some steps we will take to keep your identity confidential are: The information about patterns of use will be stored in encrypted form on the cloud. The combined information will be stored by codes and your name will be kept separate.
The research assistant for the study will sign a Non-Disclosure Agreement, agreeing to maintain all research subject’s confidentiality related to their participation in the study.
The methods we will use to secure your information include: All records of email exchanges between us will be deleted from our computers at the end of your participation, and to the extent feasible, from the server. Electronic data will be stored in a password protected encrypted folder.
Your information will be kept confidential to the extent allowable by law.
We will make every effort to safeguard your data, but as with anything online, we cannot guarantee the security of data obtained via the Internet.
CAN YOU CHOOSE TO WITHDRAW FROM THE STUDY EARLY? You can choose to leave the study at any time. You will not be treated differently if you decide to stop taking part in the study. If you choose to leave the study early, data collected until that point will remain in the study database and may not be removed.
It’s possible that the investigator conducting the study may need to remove you from the study. This may occur for a number of reasons. You may be removed from the study if:
- Your participation in the study is more risk than benefit to you, or
- The study is stopped early for a number of scientific reasons.
WILL YOU RECEIVE ANY REWARDS FOR TAKING PART IN THIS STUDY? None other than the possible benefits from listening to the exercise. You can also have access to the full exercise program if you want it.
WILL YOU BE GIVEN INDIVIDUAL RESULTS FROM THE RESEARCH STUDY? You will know how much you participated by the number of times you listened to the self-relaxation exercise over the two week period. You will have an option to receive a summary report of the study results.
WHAT ELSE DO YOU NEED TO KNOW? If you volunteer to take part in this study, you will be one of about 75 people to do so.
WILL YOUR INFORMATION BE USED FOR FUTURE RESEARCH? Grouped information about use of the exercise by the people who participate in this study may be shared with other investigators so they can use it for research related to this study. We may use your individual information about use of the exercise for future research but not with any individual identification attached as all information identifying you is separated from the exercise use information and discarded as noted below. We will save the information about your use of the exercise indefinitely.
This study is part of a series in which we are learning about relationships between low back muscle tension and low back pain in people’s normal environments (as opposed to recordings made in clinics or laboratories). We do this by having people with muscle tension related low back pain wear harmless, portable recording devices during all waking hours for several weeks at a time. The devices can’t be seen while being worn. The information recorded by the devices is transmitted to your smart phone or a smart-phone size storage device so it can be stored for future analysis. People participating in these studies record their pain levels when the levels change any time throughout all waking hours. We may ask you if you would like to participate in one of these studies. Agreeing to participate in this study does not obligate you to participate in any other studies.
WHERE WILL INFORMATION BE STORED AND FOR HOW LONG? We will store your emails on the study computer until you complete your participation. We will send your information to a “cloud” computer system and it will be stored by a code and combined with the patterns of other people. We will keep your study data indefinitely but destroy all other documents related to you at the longest after three years.
You need to agree to be contacted at your email and voicemail to participate in this research study.
As a study participant, is it ok to send you emails?
Yes_____ No_____
Email address:__________________________________________
As a study participant, is it ok to leave a voicemail on your phone?
Yes_____ No_____
Phone number:___________________________________________
Summary Report: At the end of this study, a summary of the general findings will be available. If you would like a copy of the report sent to you by email, please check the box.
_____I would like to receive a copy of the Summary Report sent by email.
INFORMED CONSENT SIGNATURES
This consent includes the following:
- Key Information Page
- Detailed Consent
DO NOT Sign this study explanation / consent to participate if you have questions.
We are available to go over the form with you and answer questions privately. Contact Dr. Sherman at https://ansr.me/VWv70 (This is a site that guarantees the anonymity of senders. You must enter your email if you want a reply.) or Phone us at 1- 800 530 6658.
You are the research subject. You will receive a copy of this consent form after it has been signed.