Molly Ayala
Percutaneous electrical nerve stimulation (PENS) is a therapeutic treatment for patients with overactive bladder symptoms, chronic pelvic pain, and chronic musculoskeletal or neuropathic pain conditions. PENS is a combination of electroacupuncture and transcutaneous electrical nerve stimulation, involving the insertion of needle electrodes into the skin to stimulate peripheral sensory nerves. While PENS has been approved by regulatory agencies outside the United States for treating fecal incontinence, its usage for this purpose has not been approved in the US. However, the US Food and Drug Administration (FDA) has cleared certain PENS devices for marketing through the 510(k) process, and they can be used for reducing symptoms of opioid withdrawal and aiding in pain reduction when combined with other treatments for IBS.
| Characteristics | Values |
|---|---|
| Purpose | To provide an alternative or improved treatment option for individuals with chronic musculoskeletal or neuropathic pain conditions. |
| Mechanism | Uses small needles that penetrate the skin to deliver electrical stimulation closer to the nerves or muscles. |
| Target Area | Peripheral sensory nerves in the soft tissue. |
| Conditions Treated | Overactive bladder symptoms, chronic pelvic pain, diabetic neuropathy, opioid withdrawal, restless leg syndrome, and irritable bowel syndrome. |
| FDA Status | Some devices have received FDA clearance or approval, including the IB-Stim device, PENFS device, Sparrow Ascent®, and NTX100 Tonic Motor Activation System. |
| CPT Code | 64999 |
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What You'll Learn
- The IB-Stim device for IBS received FDA approval in 2018 for patients aged 11-18
- PENS is recommended for patients who don't respond to transcutaneous electrical nerve stimulation
- PENS is used to treat chronic pain conditions, including back pain, neck pain, and headaches
- PTNS is used to treat overactive bladder symptoms, but it hasn't been approved for treating fecal incontinence in the US
- Peripheral nerve stimulation may be considered medically necessary for treating chronic pain that is refractory to other therapies
The IB-Stim device for IBS received FDA approval in 2018 for patients aged 11-18
The IB-Stim device, a percutaneous electrical nerve stimulator, received FDA approval in 2018 for the treatment of irritable bowel syndrome (IBS) in patients aged 11-18. Innovative Health Solutions, the creators of the device, received approval to market IB-Stim as a prescription-only treatment. It is designed to be used as an adjunct to other IBS therapies to reduce functional abdominal pain.
IB-Stim is a small, single-use, battery-powered electrical nerve stimulator that is placed behind the patient's ear. It emits low-frequency electrical pulses to stimulate branches of certain cranial nerves continuously for up to five days, after which it needs to be replaced. The device can be used for up to 120 hours per week for up to three consecutive weeks. The electrical stimulation is delivered to branches of the cranial nerves (V, VII, IX, and X) and the occipital nerves.
The FDA reviewed data from a clinical study that included 50 patients aged 11-18 with IBS. Of these, 27 patients were treated with the device, while 23 received a placebo. The study showed that IB-Stim treatment resulted in at least a 30% decrease in usual pain at the end of three weeks in 52% of treated patients, compared to 30% in the placebo group. It also demonstrated greater improvement in composite Pain Frequency Severity Duration (PFSD) scores compared to the placebo group.
The FDA's decision to approve the device reflected its commitment to advancing the development of pediatric medical devices and providing safe and effective treatment options for adolescents with IBS. IB-Stim offers a safe and innovative approach to managing IBS symptoms by targeting nerve stimulation to provide pain relief.
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PENS is recommended for patients who don't respond to transcutaneous electrical nerve stimulation
Percutaneous Electrical Nerve Stimulation (PENS) is a therapeutic treatment for patients experiencing overactive bladder symptoms (urinary urgency, urinary frequency, and/or urge incontinence). It is also used to treat chronic pelvic pain.
PENS is a type of neuromodulation that involves stimulating peripheral sensory nerves at the dermatome levels corresponding to the local pathology. The most well-known form of PENS is Percutaneous Tibial Nerve Stimulation (PTNS), which directs electrical stimulation to the nerves responsible for bladder and pelvic floor function. PTNS has been approved by regulatory agencies outside the United States to treat fecal incontinence, but it has not been approved for this usage in the US.
Transcutaneous Electrical Nerve Stimulation (TENS) is a similar procedure that is administered to the surface of the skin. TENS can be beneficial for patients with skin problems or infections, or for those with a phobia of needles. However, the skin can act as a barrier during TENS, and some electrical stimulation may be lost through the skin's natural defences.
PENS, on the other hand, is administered in the actual vicinity of nerve endings, allowing it to directly target the nerves causing pain. This is why PENS is generally regarded as a more effective procedure than TENS. A study of 60 patients with chronic low back pain found that PENS therapy produced greater improvements in physical and mental health components, pain, physical activity, and quality of sleep compared to TENS therapy.
Therefore, PENS is recommended for patients who do not respond to TENS as it can more effectively reduce pain levels, improve sleep, and increase mobility.
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PENS is used to treat chronic pain conditions, including back pain, neck pain, and headaches
Percutaneous Electrical Nerve Stimulation (PENS) is a minimally invasive electrical stimulation treatment for chronic pain. It is a novel analgesic therapy that works by changing the way pain nerves relay their pain messages. PENS is a drug-free treatment, with no medication being injected.
The treatment involves the use of extremely thin needles, similar to acupuncture needles. Up to 10 needles (5 electrical channels) are used, delivering non-painful electrical stimulation near the nerves and in the tissues under the skin. Most patients feel a tolerable tapping or tingling sensation and do not find the treatment uncomfortable. The treatment sessions typically last 20-30 minutes, and further treatments are provided up to 10 times over several weeks. Many patients feel immediate improvement after the first or second treatment due to the relaxation of muscle spasms.
PENS is a useful complementary therapy to analgesics and antimigraine drugs for the short-term management of headaches. It is important to note that PENS should not be used on patients with epilepsy, heart disease, or those who are pregnant or may be pregnant. Patients on anticoagulants should also refrain from PENS treatment.
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PTNS is used to treat overactive bladder symptoms, but it hasn't been approved for treating fecal incontinence in the US
Percutaneous tibial nerve stimulation (PTNS) is a non-surgical procedure that involves placing a slim, needle electrode near the tibial nerve at the ankle. The needle is then connected to a device that delivers mild electrical pulses to the nerve, which travels to the sacral nerve plexus—a group of nerves responsible for bladder function. PTNS works by indirectly providing electrical stimulation to the nerves responsible for bladder and pelvic floor function.
PTNS is used to treat overactive bladder (OAB) symptoms, which include a sudden and severe urge to urinate, leaking urine, urinating frequently during the day, and nocturia. PTNS has been shown to be effective in reducing these symptoms, with some patients reporting complete improvement after 12 weeks of treatment. It is a relatively inexpensive, low-risk, and painless procedure with minimal side effects. PTNS is generally used after other conservative treatments, such as behaviour modifications, Kegel exercises, and medications, have been unsuccessful.
While PTNS has been approved by regulatory agencies outside the United States for treating fecal incontinence, it has not yet received approval for this usage in the US. However, given its positive effects on the pelvic floor, it is possible that it may receive FDA approval for this indication in the future.
The National Institute for Clinical Excellence (NICE) in the UK supports the use of PTNS as a routine treatment for overactive bladder syndrome. NICE highlights the effectiveness and safety of PTNS, provided that patients understand the procedure and provide informed consent.
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Peripheral nerve stimulation may be considered medically necessary for treating chronic pain that is refractory to other therapies
Peripheral nerve stimulation (PNS) is a treatment for patients with peripheral neuropathy and other neuropathic pain conditions. It is considered ideal for patients who have not experienced pain relief from conservative, alternative, and interventional therapies. The procedure involves surgically implanting a small electrical wire (electrode) along the damaged peripheral nerves to deliver rapid electrical pulses. These pulses feel like mild tingles in the body, called paresthesias, which help minimise pain symptoms.
PNS requires a trial period before a permanent device can be surgically implanted. The dorsal root ganglion (DRG) or peripheral nerve solution is selected for the individual patient according to their unique presentation and context. This may cover lower abdominal pain or some component of chronic or refractory post-surgical pain, such as hip, shoulder, knee, or ankle pain that has failed conservative therapies.
The mechanism of action of PNS is not yet fully understood but is felt to be related to large-fibre activation, as described by Wall and Melzack’s gate control theory. There is also evidence that conduction blockade may be involved.
A systematic review of the available literature on PNS revealed significant improvement in pain for the treatment of neuropathic pain conditions. There is level II evidence supporting the use of PNS to treat refractory peripheral nerve injury.
Additionally, percutaneous electrical nerve stimulation (PENS), a form of neuromodulation, has been shown to be effective in treating patients with overactive bladder symptoms and chronic pelvic pain. PTNS, a type of PENS, has been approved by regulatory agencies outside the United States to treat faecal incontinence but has not been approved for this usage in the US.
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Frequently asked questions
PENS is a therapeutic treatment for patients with overactive bladder symptoms, chronic pain, or diabetic neuropathy. It involves applying electrical stimulation through small needles that penetrate the skin.
PENS uses needle electrodes to stimulate peripheral sensory nerves in the soft tissue. It creates an electrical field that hyperpolarizes c-fibers, preventing action potential propagation along the pain pathway of small-diameter pain fibers at the spinal cord level to inhibit pain transmission.
PENS is not a single device but a therapy involving many devices. Some devices used in PENS therapy have been cleared for marketing by the FDA through the 510(k) process. However, it is important to note that the FDA approval of a device does not guarantee its effectiveness for a particular use case.
The IB-Stim device by Innovative Health Solutions received de novo FDA approval in 2018 for treating patients aged 11-18 with functional abdominal pain associated with irritable bowel syndrome (IBS). The PENFS device by DyAnsys, Inc. has also received FDA 510(k) clearance for reducing pain when combined with other IBS treatments. In 2023, the Sparrow Ascent® by Spark Biomedical was cleared by the FDA under the 510(k) process for use in patients experiencing opioid withdrawal.
Transcutaneous electrical nerve stimulation (TENS) is often recommended before PENS. Electrical muscle stimulation (EMS) is another alternative that directs current at weakened muscles to prompt muscle contraction and gradual strengthening.
