Frequently Asked Questions
About PainPause
What is PainPause made up of?
PainPause features a medical adhesive backing, similar to a bandage, with arrays of tiny metal micro-points and springs. The springs generate force on the micro-points that enable them to penetrate the skin which shuts down pain. The springs also reduce skin irritation that can occur with other patches.
Is PainPause easy to use? Is it painful?
PainPause is easy to apply, just like a bandage. While some discomfort occasionally occurs when applying the device, it is typically mild and temporary.
What is in the package that contains the devices?
The package includes a total of four devices - two sterile pouches each of which contains two devices. The insert provides detailed instructions for use, including how to apply and remove the device, locations of application for different painful disorders, care guidelines, and information on potential complications and risks.
Does Painpause contain any chemicals or drugs or electrical components?
No. PainPause is free from drugs, chemicals, and electrical current, making it a safe alternative to other pain relief products.
Kinds of Pain Treated
Can PainPause be used to treat chronic pain? How long does pain relief last?
Yes, PainPause is ideal for treating chronic pain. A single device can provide pain relief for up to a week. If the pain persists, another patch can be applied, provided the skin in the area is not irritated.
Can PainPause be used to treat severe pain?
Yes, PainPause has been effective in treating severe pain in clinical studies. However, if the pain is new or occurs in an unexpected location, consult a healthcare provider before using PainPause.
How fast does it take for pain relief to occur?
Pain relief usually begins within minutes to a few hours after application.
What kinds of conditions causing pain can be treated with PainPause?
PainPause can be used to treat a broad spectrum of pain conditions. It is effective for treating severe pain as well as mild to moderate pain.
It provides pain relief for up to a week. This makes it useful for conditions where pain lasts for more than a few days whether it be for several days to a few weeks due to an acute injury, several weeks to a few months for subacute conditions (e.g., carpal tunnel syndrome and plantar fasciitis) to several months to years for chronic pain.
It has been demonstrated to provide pain relief for a broad range of painful musculoskeletal disorders such as those in joints and the spine. These disorders include back pain and sciatica; knee, neck, hip, and shoulder pain; pain due to soft tissue and muscular injuries; and muscle spasms, tendinitis, plantar fasciitis, carpal tunnel syndrome, tennis elbow, and golfers elbow
Does PainPause treat the underlying condition that causes the pain?
PainPause is not intended to treat the underlying cause of the pain. In most cases of chronic pain, the cause is actually unknown. But in cases where the cause has been identified, it is not intended to correct the problem. Rather, it is intended to treat the pain caused by the problem.
Where can PainPause be applied on the body?
PainPause can be applied just about anywhere on the body. However, it should not be applied to areas that may be moist or with hair, such as the armpits or groin.
Do not apply PainPause over fingers and toes or on the hand or wrist since the devices may be at risk of falling off or become painful with movement and/or wearing shoes.
Can PainPause be used to treat the elderly or people with underlying medical conditions?
It has been tested in the elderly with excellent outcomes in providing pain relief. In addition, since it does not contain drugs or chemicals, it is a less risky treatment and thus has the potential to be used safely in patients with other medical conditions, such as cancer, diabetes, heart disease, kidney disease and other disorders. Check with your provider if you have questions.
Can PainPause be used on sensitive or fragile skin?
Yes, PainPause has demonstrated excellent results when used on people with sensitive or fragile skin such as the elderly.
What clinical evidence do you have to support the use of the device?
A pilot clinical study was conducted in 18 patients with severe chronic low back pain. Clinically significant pain relief was demonstrated in 17 of the 18 patients (94%). Moreover, pain relief continued for one week after a single application of the device in a majority of those treated. This level of pain relief is much higher than what has been reported with other treatments including those provided by healthcare providers and prescription drugs (e.g., surgery, steroid injections, physical therapy, narcotics, acupuncture) which have been reported to provide significant pain relief in only 5-30% of patients.
Using PainPause
What are the most important things you need to know about using PainPause?
• Ensure the application site is completely dry before applying.
• Avoid touching the adhesive or micro-points during application.
• Keep PainPause covered while on with the Cover provided in the package.
If PainPause comes loose, another device should be applied. PainPause may also be covered with an adhesive bandage or gauze attached to the skin with a bandage.
o The device should remain in place for 7 days to achieve maximum benefit.
• To reduce the risk of the PainPause coming loose:
o Keep the device covered at all times while on the skin with the Covers provided in the package (a bandage or gauze may be applied in place of the cover).
o Avoid rubbing on the area when:
- Putting on or taking off clothing
- Drying area with a towel after a shower (pat area dry)
- Do not wear tight clothing or a tight belt (if device is placed along waistline)
o Avoid swimming or vigorous exercise that creates excessive sweat
Can more than one PainPause be applied?
Yes, if the painful area is larger than can be covered with one device, additional devices can be used. Devices should be applied adjacent to one another. They should not touch or overlap each other. For more than one painful area, devices can be applied over each area.
If devices are applied adjacent to one another, remove the device gently if you plan to keep the other on for a longer period of time. Otherwise, you will disturb the other device and it may come off or cause skin irritation.
Can a PainPause device be reapplied if its placement is not in the right place or not securely attached to the skin?
No, the device should be removed and discarded in a safe receptacle. A new device should be applied. Each device can only be used once.
How long should PainPause remain on the skin?
PainPause should ideally remain on the skin for one week. If discomfort or irritation occurs earlier, remove the device immediately.
What happens if PainPause falls off before the recommended time of treatment?
It can be replaced with another PainPause device if available, but only if the skin does not show irritation (e.g. redness) or skin-related pain. In addition, the total combined duration that the previous and new device can remain on the skin is 7 days.
If PainPause has been attached to my skin for up to several days of treatment, how long should I wait before I can apply another device to treat my pain?
Please wait at least two days. However, if skin pain or irritation persists, it is recommended to wait until skin pain and redness have disappeared.
Who should apply and remove PainPause?
PainPause can be applied by and on just about any adult.
Safety & Risks
What complications can occur with PainPause?
Skin irritation, mild bleeding, or allergic reactions may occur but are typically mild and temporary. If severe irritation or infection develops, remove the device and consult a healthcare provider.
Is the material contained in PainPause safe and is it hypoallergenic and latex-free?
Yes, PainPause is made from medical-grade materials, including stainless steel micro-points (same metal as in surgical staples and surgical implants) and hypoallergenic adhesive. It is also latex-free. The micro-point technology of PainPause is identical to that of the wound closure product, microMend, which has been marketed in the US for five years. There have been serious complications or adverse events reported with over 250,000 units sold.