ActiPatch: Can It be a Tool to Empower Chronic Pain Patients?

Sir,

Chronic pain syndrome is a difficult entity to manage for clinicians.[1] The management is multimodal that comprises pharmacological approach in the form of opioids, nonsteroidal anti-inflammatory drugs, gabapentinoids, antidepressants, antiepileptic agents, and a lot of other nonopioid medications. The patients are also advised nonpharmacological therapies such as physiotherapy sessions, acupressure, acupuncture, aromatherapy, and TENS.

ActiPatch (ActiPatch^®– BioElectronics Corporation) is a low-power, pulsed shortwave therapy (PSWT) device that is available and marketed as an over-the-counter (OTC), class II (a) medical device in the European Union right now [Figure 1]. ActiPatch was approved by the US-FDA as an OTC product for managing persistent pain in 2017.[2] The device is approved and used for managing certain specific categories of chronic pain. The device operates at a frequency of 27.12 MHz and pulses of 1000 times per second; each pulse sustains for a duration of 100 μs. The peak incident power on tissue, as measured into a 50 Ω load, is 73 μW/cm².[3] With its use, there is no heat production and neither the patient experiences any abnormal or unpleasant sensation when the PSWT is delivered. The product has no medication which is supposed to get released with its use. Patients can continue the ongoing medication as it does not pose any issues of interaction with ongoing therapy.

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Figure 1

Image showing ActiPatch^® (BioElectronics Corporation, MD, USA) which is a commercially available, over-the-counter medical device used for treating chronic pain (reprinted with permission from BioElectronics Corporation) (https://www.actipatch.com/)

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The mechanism of action of ActiPatch is by stochastic neuromodulation due to which there is regulation of activity of peripheral afferents at the site of application. The plausible explanation of mechanism of action of ActiPatch is that by delivering PSWT, there is a possibility of reversal of central sensitization which has earlier developed due to persistent peripheral nerve endings triggering. There is a similarity with TENS, but TENS cannot be used for a longer duration due to discomfort such as skin irritation and tingling during stimulation. The product can be used for a total duration of 720 h and also has an on/off option. ActiPatch is available in three forms: back wrap, knee wrap, and as an adhesive which can be applied as per specifications at the site of chronic, persistent pain. The product has been used in several situations such as back pain, knee/shoulder/ankle arthritis, postoperatively after knee/spine surgeries, tendonitis, ligament injury, elbow/wrist persistent pain, plantar fasciitis, and fibromyalgia. The product appears to be a boon for managing musculoskeletal pain, which is difficult to treat and is quite distressing.

Staelin et al. collected responses from 1394 participants who took the 7-day trial of ActiPatch.[4] The authors found that 52% of subjects had a clinically significant pain reduction (40% or more), with an average reduction of 66% at the end of 3 months. 49% of patients suffering from chronic back pain were either able to reduce or stop the regularly used analgesic medications. Even though these data are from a survey, the results appear encouraging. Rawe and Kotak suggested that ActiPatch appears to be an opioid-free, medication-free, addiction-free, or dependence-free treatment modality that can be used effectively in patients suffering from chronic musculoskeletal pain of varied locations.[5] The results were from a registry involving 40,000 patients who used the product out of which 5000 assessments were done.

PSWT with ActiPatch appears to be a safe and reasonably effective modality for treating certain types of chronic pain. There are no absolute contraindications to its use and can be safely used with any ongoing pain medication. The device does not lead to adverse effects, which is encountered with pharmacotherapy. Further studies might explore its role in managing chronic pain syndromes of varying etiology and would enlighten clinicians with its safety and efficacy.