Spinal Stenosis Pain Study
- I understand and am willing to sign and date the study -specific “Subject Informed Consent” at the time of my installation/meeting.
- I am 21 – 85 years of age.
- I have not been referred to this study by any particular physician currently responsible for my care.
- I have had a diagnosis of spinal stenosis back pain demonstrated by medical history, physical examination, or radiographic imaging. Radiographic diagnosis shows evidence of central or lateral recess stenosis or referential evidence of other low back condition. I am experiencing leg and/or back pain and the manifestation of one or more of the following phenomena:
- Radiculopathy (“pinched nerve” pain or radiating pain on one or both sides)
- Sensory deficit (numbness)
- Motor weakness
- Reflex changes
- Disc herniation
- Neurogenic claudication (pain or weakness due to compressed nerves- usually while walking)
- Osteophyte formation or hypertrophy of the facet joint (bone spurs or painful inflammation of the facet joint)
- I may be a potential candidate for decompression (different types of surgeries to relieve pressure on the nerves) and spinal fusion.
- I agree to participate in this 28-day study as explained on the Application/Subject Informed Consent Form.
- I have active spinal and/or systemic infection.
- I have a systemic disease or condition, which affects my ability to participate in the study requirements.
- I have systemic disease or condition, which affects my ability to participate in the study requirements or the ability to evaluate the efficacy of the investigational product (i.e., active malignancy, neuropathy).
- I have been treated for alcohol and/or drug abuse in an in-subject substance abuse program within 6 months prior to the proposed study enrollment.
- I own or have access, as necessary and required, to a smartphone capable of receiving Internet email and accommodating the playback of audio/sound files and the use of earbuds/headphone.
- I have the ability and knowledge to use each of features herein immediately above, in #1.
- I have not suffered from, and is not being treated for any mental, physical or psychological disorder or condition which, if known, would be of sufficient basis/reason to preclude subject from participating in the study.
- All of the information provided, regarding my participation in the study, is both factual and truthful in its totality and completeness.
The purpose of the study is to determine if: “Listening, on a daily-basis, to a specially designed audio composition can help to reduce pain and improve emotional or physical function in patients with spinal stenosis?”
First – What you’ll be doing and how we’d like you to do it;
Second – Tell you about the forms & questionnaires you’ll be filling out;
Third – Explain the equipment you’ll need and will be using for the 28 days of the study
Fourth – Tell you about the Daily Diary you’ll be keeping.
Now: THERE ARE SEVERAL VERY IMPORTANT THINGS YOU NEED TO UNDERSTAND…
FIRST: TAKING PART IN THIS STUDY IS VOLUNTARY. YOU ARE FREE NOT TO TAKE PART OR TO WITHDRAW AT ANY TIME, FOR WHATEVER REASON. NO MATTER WHAT DECISION YOU MAKE, THERE WILL BE NO PENALTY OR LOSS OF BENEFIT TO WHICH YOU ARE ENTITLED. IN THE EVENT THAT YOU DO WITHDRAW FROM THIS STUDY, THE INFORMATION YOU WILL HAVE PROVIDED WILL BE KEPT IN A CONFIDENTIAL MANNER. IF YOU DECIDE TO PARTICIPATE, AND THEN CHANGE YOUR MIND, AND WANT TO QUIT – ALL YOU HAVE TO DO IS TELL US. THAT DECISION IS COMPLETELY UP TO YOU. SO IF YOU DECIDE TO DO SO, JUST LET US KNOW BY CALLING: 561/372-6202 OR SEND US AN EMAIL AT: SUPPORT@SOUND-HEALTH.ORG.
SECOND: ONLY THE FIRST 20 PEOPLE, SIGNING-UP AND ATTENDING OUR “INSTALLATION MEETING” WILL BE ABLE TO PARTICIPATE IN THE STUDY (WE’LL SEND YOU A PERSONAL NOTICE AS TO WHEN AND WHERE THE INSTALLATION MEETING WILL BE HELD). OUR STAFF WILL BE THERE TO ANSWER ALL OF YOUR QUESTIONS AND EXPLAIN EVERYTHING YOU NEED OR HAVE TO KNOW ABOUT THE STUDY. ALL YOU HAVE TO DO IS: BE THERE!!
THIRD: THE RESEARCHERS HAVE NOT BEEN MADE AWARE OF NOR HAVE ANY POTENTIAL RISKS BEEN IDENTIFIED AS BEING ASSOCIATED WITH THE PROTOCOLS, APPLICATIONS AND/OR PROCEDURES ATTENDANT TO THOSE BEING EMPLOYED IN THE STUDY.
FOURTH: YOU MAY OR MAY NOT BENEFIT FROM PARTICIPATING IN THIS RESEARCH STUDY. NO PAYMENTS WILL BE MADE FOR PARTICIPATING IN THIS STUDY AND NO INCENTIVES ARE BEING OFFERED FOR PARTICIPATING. THERE IS NO SPONSOR SUPPORT FOR THIS STUDY AND ALL COSTS ARE BEING BORNE BY SOUND-HEALTH.
As for the paperwork we mentioned – don’t worry – we will help you with all of that, at the “installation meeting,” before you actually start the study.
Now, here’s the really exciting part – what you’re going to be listening to. We’re going to be sending to you and audio file over the Internet right to your smartphone via your email address. We will give you earbuds or headphones to listen with. So when you download it, the audio file is on your phone, so you always have it.
Then, all you have to do (each day) is: find a quiet place where you can be comfortable and relax for about an hour… hopefully, without too many interruptions. Make sure your Pain Diary (with a pen) is handy. This is a very important part of the study – here’s why: Your Daily Pain Diary has relevant information about you, each day of the 28 days in the study that you’re be filling in, that we need.
So every day BEFORE YOU LISTEN, you will fill in the following information:
- The date
- Day of the week
- The approximate time of day (am or pm)
- And, your pain and mood rating – ALL BEFORE you listen…
>> THEN YOU LISTEN <<
After you settle-in & settle-down… put on your headphones (or the earbuds) find and click on the file on your phone. Adjust the volume to a comfortable level (JUST LOUD ENOUGH FOR YOU TO HEAR THE SOUNDSCAPE). In fact, you might want to set it so you can BARELY HEAR IT! The important thing is that: it’s NOT too loud.
So, AFTER YOU LISTEN… you’ll fill in the following information:
- Rate your pain and mood, again – (AFTER section)
- Mark what “effect” the listening had on you…
- And, if you choose… write down anything else you’d like to tell us, or would like us know. [Again, doing this is up to you… if you’ve done the above, you’ve given us what we need.]
ONE LAST THING…
IF YOU MISS A DAY – PLEASE WRITE THAT DOWN, AT THE BOTTOM OF THE BLOCK OF THE DAY YOU MISSED.
Well, that’s it! Pretty simple and easy, right?
Now, because the “SoundScape” isn’t a song – it won’t be boring… you’ll actually start hearing something new in it, every time you listen. Also, by NOT having the volume turned up loud… THE SOUNDSCAPE WON’T GET IN THE WAY OF WHAT YOU’RE DOING… THINGS LIKE: READING, KNITTING, COMPUTING, WRITING, RELAXING, ETC. – ALL WHILE YOU’RE LISTENING.
Well, that’s all there is too it.
If you have any questions or, need assistance, you can email us at: firstname.lastname@example.org; or call SoundHealth at: 561-372-6202 and leave a message… someone will get back to you directly.
If you have problems with the equipment we can generally take care of them within a day, after we hear from you. Remember, when you call: be sure to leave detailed message – especially your telephone number – so, we can have the proper person get back to you.
From both basic science research and everyday experience we know that music has powerful psychological effects. Music is capable of inducing and modifying moods and emotions. After all, marches are not played at bedtime, funeral dirges are not played at weddings, lullabies are not heard at parades, and Gregorian chants are not played in supermarkets.
So what does this have to do with our study? For decades it has been recognized that the sensation of “pain” is a complex interaction of physiological and psychological phenomena. Indeed, the International Association for the Study of Pain (IASP) clearly states in its definition of pain that pain is “a sensory and emotional experience”. The sensory, or physiological component, addresses the “intensity of the pain”, while the emotional, or psychological component, addresses the “suffering” aspect. And it is now well-established that not only do these two components of the “pain experience” influence each other, but that the suffering component can be more damaging to a patient’s life than the “pain” itself.
Which now brings us to the purpose and rationale behind our study.
The brain has an innate capacity to “change” under certain conditions. This ability to change is known as “plasticity”. Our goal is to enlist this plastic capability and effect a change in the way your brain has been functioning under the conditions of your “chronic pain”. The soundscapes to which you will listen for one hour each day, are designed to produce, through this auditory input, the emotional states of relaxation and a sense of well-being (two emotions you probably have not been feeling for some time now). We propose that the one-hour daily respite from your usual “discomfort”, over the 28 days of your listening, will induce beneficial changes, such as up-regulation and down-regulation of certain neurotransmitters in brain regions known to be involved in “suffering”. These regions include, but are not limited to, the hypothalamus, hippocampus, and amygdala, collectively known as the limbic system. And these regions in turn, influence, and are influenced by, other regions involved in the release (or no release) of so-called stress hormones, which not only raise our blood pressure but cause other potentially-harmful responses.
If the calming aspects of our soundscapes can indeed re-program your limbic system and thereby reduce the suffering component of your pain, then there should be a concomitant improvement in your functioning and your quality of life.
The questionnaires that you will be answering before and after the 28 day listening period, as well as the daily pain diary that you are asked to fill out, will help us determine if we have achieved our goal.