Chronic pain is a complex condition that affects people differently. As a result, you may not experience pain relief and other benefits from using Quell. You may return Quell within 60-days for any reason.
Should I consider using Quell if my pain extends beyond the lower extremity?
Quell is placed on the upper calf and is intended to provide pain relief in that leg, foot and knee. However, some people experience chronic pain in several body locations. In this case, Quell addresses the lower extremity portion of your chronic pain. The device may help you become more active, sleep better and improve your mood, all of which can improve your overall health and chronic pain. Moreover, Quell will free you up to look into specific pharmacological and non-pharmacological approaches for other pain locations such as topical analgesics, physical therapy, yoga and cognitive behavioral therapy. Ultimately, each individual must determine if Quell is useful in managing their chronic pain. It is for this reason that you have 60-days to explore Quell’s impact on your specific pain pattern and can return it for any reason.
How should I use Quell if I have pain in both legs?
Quell is placed on the upper calf and is intended to provide pain relief in that leg. However, it is not uncommon for people to suffer from pain in both legs. In this case, we recommend wearing Quell on the leg with the most pain. If you are experiencing a similar level of pain on both sides, then we suggest alternating every 3-5 hours or after using Quell overnight.
Has Quell been evaluated by the Food and Drug Administration (FDA)?
Quell received FDA 510(k) Clearance in 2015 (K152954). FDA Clearance means that the FDA has deemed the device to be as safe and effective as a medical device previously cleared by the FDA; this is called “substantially equivalent.” This process is different from FDA approval of drugs and typically does not involve a review and analysis of clinical data. All transcutaneous electrical nerve stimulators (TENS) must be FDA cleared before they are marketed. The FDA 510(k) clearance for Quell specifically states that it may be used during sleep.
Has Quell been reviewed by any professional medical associations?
Quell has received the American Podiatric Medical Association (APMA) seal of approval. The APMA Seal of Approval recognizes products that have been found beneficial to foot health and of significant value when used in a consistently applied program of daily foot care and regular professional treatment. The Seal is not an endorsement, but a recognition granted to products. The seal is granted to a product after the Podiatric Seals Committee, a standing committee of the APMA, evaluates and determines whether the product allows normal foot function and promotes quality foot health. Additionally, evidence of usefulness and safety must be established.
Is Quell eligible for FSA and HSA reimbursement?
Yes. Quell is an over-the-counter transcutaneous electrical nerve stimulation (TENS) device and therefore the Quell device and Quell electrodes are eligible over-the-counter products for flexible spending accounts (FSA), health savings accounts (HSA) and health reimbursement arrangements (HRA).
Has the effectiveness of Quell for lower extremity chronic pain been evaluated in clinical studies?
Although Quell has been evaluated in several clinical studies, both prospective clinical trials as well as observational studies, the efficacy of Quell for lower extremity chronic pain has not been specifically evaluated in a placebo-controlled randomized controlled trial (RCT), which is the gold-standard for assessment of medical interventions. Quell has been evaluated in several published observational studies that included individuals with chronic lower extremity pain. An observational study differs from an RCT in that the study investigators passively “observe” the results of a treatment rather than creating and comparing specific treatment groups. Observational studies may better reflect real-world outcomes than RCTs, however they are susceptible to bias that can lead to overestimation of the benefits of a treatment. The Quell studies suggest that, on average, individuals who consistently used Quell experienced modest pain relief. However, some people did not experience pain relief. Moreover, as these were observational studies, Quell was not compared to a placebo device. As a result, it is not possible to know if the observed pain relief was due to Quell specifically, to a placebo effect, to the normal course of chronic pain or to a combination of the three. There are several ongoing clinical studies of Quell and other TENS devices, as researchers work on how best to incorporate “placebo” controls into RCTs of TENS given the difficulty of creating placebos for wearable, pulsing devices. Placebo controls, if feasible, will allow TENS researchers to quantify how much of the observed pain relief with Quell is due to the product specifically, as opposed to the “placebo” effect or the normal course of chronic pain.
Transcutaneous electrical nerve stimulation (TENS) is safe and has been prescribed by physicians for decades. Each individual needs to determine whether TENS, in general, and Quell specifically, is useful in managing their chronic pain. It is for this reason that you may return Quell within 60-days for any reason.