The study will take place over 3 menstrual cycles. The first menstrual cycle is considered the “control” phase where you will only use Ibuprofen for pain relief. Menstrual cycles 2 and 3 are randomized. For instance, you could be randomized to use only the UNO + Butterfly pad on cycle 2 and only the DUO set-up on cycle 3 or only the DUO set-up on cycle 2 and only the UNO + Butterfly pad on cycle 3.
For scientific purposes, we have randomized the order of when you will use the UNO + Butterfly pad and when you will use the DUO set-up. For instance, you might be randomized to use only the UNO + Butterfly pad on cycle 2 and only the DUO set-up on cycle 3 or only the DUO set-up on cycle 2 and only the UNO + Butterfly pad on cycle 3. It’s important that you only use the UNO + Butterfly pad or DUO set-up during the specified months.
The Period Pain Relief Program in the PowerDot app already has preset parameters for the electrical stimulation session. All you have to do is control the intensity. Everybody is different. Increase the intensity to a number that is intense, but not painful.
This is not common, but does happen. The video of the “Duo Set-Up” above can can help with this. But, in order to feel the same sensation from each pod, scroll down on the screen where you control the intensity of the electrical stimulation and hit the toggle button that says “link devices”. This allows you to control the intensity of each pod individually. You can then “sync” the pods again so that the intensities are the same for your next session.
You will use the Period Pain Relief Program whenever you are experiencing pain during menstruation (when you experience your period).
You should use the Period Pain Relief Program any time that you are in pain. You can even leave it on and use it for multiple sessions throughout the day.
Yes! We have the program run for 30-90 minutes so you don’t forget about it. Just enter your pain score at the end of one session and start another session.
You have two options. One, if you can, start another session of the Period Pain Relief Program. Two, if you cannot start another session, you may take 400mg of Ibuprofen. If the Ibuprofen doesn’t seem to work after 30-45 minutes, start another session of the Period Pain Relief Program before taking more Ibuprofen.
No, you should not take Ibuprofen and then start a session of the Period Pain Relief Program. This makes it hard to determine what may be
causing pain relief. So, when in pain, start with a session of the Period Pain Relief Program. Then you have two options. One, if you can, start another session of the Period Pain Relief Program. Two, if you cannot start another session, you may take 400mg of Ibuprofen. If the Ibuprofen doesn’t seem to work, start another session of the Period Pain Relief Program before taking more Ibuprofen.
For consistency during the study, we are asking that all participants use Ibuprofen.
Yes. You may still have caffeine but try to restrict it to only 100mg if possible. Caffeine may block the therapeutic effects of TENS.
We recommend that you take PowerDot off while you sleep. If in pain before bed be sure to start a session of the Period Pain Relief Program. If you are still in pain and want to go to sleep, take 400mg of Ibuprofen.
If the pain wakes you up in the middle of the night, start a session of the Period Pain Relief Program. If you are still in pain and want to go to sleep, take 400mg of Ibuprofen.
For the purpose of this study, you will use the PowerDot on your lower abdomen only. After the study, you could then use the PowerDot on your lower back if you had pain, but you should alternate sessions. One session on your lower abdomen and then move the pad(s) to your back and perform another session. Do not place pads on your lower abdomen and back at the same time.
Please follow the link here that has instructions on the Whoop website on how to set-up your device and account.
Please follow the link here that has instructions on the Whoop website on how to accurately track your physical activity.
Yes. You can take your WHOOP off when you go to shower or to charge. Please be sure you always wear it during physical activity and while you sleep.
Yes. Your WHOOP is water resistant up to 10m (32 feet).
The PowerDot and WHOOP apps register when you connect your device to the app. Throughout the study the investigators will use this information to confirm you are completing all the different tasks that you are required to be compliant with. Non-compliance will result in a longer participation of the study and/or request for the product to be returned.
PowerDot FAQs
PowerDot is a FDA cleared electrical stimulation device. You should receive the following: Two PowerDot pods. 1 Butterfly pad and 2 sets of rectangle and circle pads. Lead cables (10cm & 25cm). Carry case. Micro USB charging cable.
**Powerdot requires iPhone 5 or later (with iOS
7.0+) or supported Android phones running Android 4.4+
The PowerDot app has many different programs. For the purposes of the
study and for compliance reasons, please only use the Period Pain Relief Program during your period in the second and third cycle conditions. Once you complete the study, you can use all of the features and programs in the PowerDot app.
For the purposes of the study and for compliance reasons, please only
use the Period Pain Relief Program during your period in the second and third cycle conditions. This reduces any confounding variables. Once you complete the study you can use all of the features and programs in the PowerDot app.
Please see the general warning and safety guidelines in the PowerDot
instructional manual. Our investigators have screened each participant in the study. However, if you have any concerns regarding your participation in the study, please consult with your physician and our research investigators. See below for contraindications:
People with electronic devices such as pacemakers and intra- cardiac defibrillators.
People suffering from epilepsy.
Use during pregnancy.
Place of electrodes to the front and sides of the neck.
Stimulation of the thoracic area of people with cardiac arrhythmia.
Stimulation of the lower legs in cases of venous thrombosis or
severe arterial obstruction (ischemia).
Stimulation of abdominal area in case of abdominal or inguinal
hernia.
In case of particular health problems, it is always recommended
that you seek the advice of a healthcare professional.
NEVER use PowerDot while driving, operating machinery, doing
heavy physical training or any other action where involuntary
muscle contraction can cause an accident or injury.
PowerDot is using a Li-Ion battery, which, when fully charged, is good
enough for at least 6 hours of continuous stimulation. In general, an
average active user should expect to re-charge PowerDot once a week or
even once in 10 days.
Charging the battery to full should not take more than 90 minutes. You
can charge Powerdot from any micro-USB connection or standard USB-
compatible AC charger. PowerDot comes with a micro-USB-2-USB
conversion cable.
To extend the lifetime of pads, we recommend you regularly clean the
sticky side with antiseptic alcohol tissues to remove hair and oil. Attach
the pads to the safety film prior to storing them.
The health and activity data collected on the PowerDot app stays there,
period. At Therabody, we understand your health and activity data is yours and yours alone. We do not collect, sell, or share any of your data, ever. In fact, feel free to test this by activating Airplane Mode on your phone. You’ll see that the app continues to work independently of any signal, as all of your data is stored locally on your device.
Contact Us
If your question was not answered in the list of FAQs, please submit a support request in the form below. We will contact you as soon as possible.
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