A novel, noninvasive, over-the-counter electromagnetic neuromodulation device (ActiPatch, BioElectronics Corp.) appears to deliver long-lasting relief in chronic pain patients.
Results of a long-term prospective study that included 240 patients who had previously experienced chronic pain relief with the device showed that at 6 months, 97% of the 240 participants sustained a 60% reduction in pain. (A short-term study included 682 individuals, and 240 of those people agreed to participate in the longer-term, 6-month study and complete three further assessments.) Responders also reported functional improvements in sleep quality, physical activity, and overall quality of life, as well as lower consumption of pain medications.
ActiPatch is sold without a prescription. The unit remains continuously powered for 7 days or as a 30-day device with an on/off switch. It does not require contact with the skin and can be worn outside a bandage or clothing.
The electromagnetic field pulsed shortwave therapy (PSWT) device is one of the three main types of neuromodulation systems. Invasive, implanted devices are also on the market, as are semi-invasive systems such as transcutaneous electrical nerve stimulation (TENS) units that require surface electrodes.
“However, these invasive and semi-invasive ‘electroceuticals’ present risks such as skin damage, postsurgical complications, and cost, factors which have largely tempered recurring use…for chronic pain management,” according to lead investigator Richard Staelin, PhD, professor of business administration at The Fuqua School of Business at Duke University in Durham, North Carolina.
Previous research shows the ActiPatch device was highly effective for short-term relief, but there was no long-term data.
To examine long-term efficacy, the investigators assessed 240 individuals who had chronic pain for an average of 6.5 years.
Arthritis and fibromyalgia were the most common conditions, and the back was the most common location. Participants had an average age of 58 years and 70% were women.
Of the 209 participants who completed the 6-month study, 58% reported mild pain, 36% moderate pain, and the remaining 6% severe pain.
The average baseline VAS score was 8.0. The mean decrease after 7 days of treatment was 5.3 points or a 65% reduction as measured by the visual analog scale (VAS).
At 6 months, the reduction was 4.9 points vs baseline or a 60% decrease. The researchers note these findings reflect “the consistency of the treatment effectiveness.”
A total 91% of the people who reported severe levels of pain after 7 days of using the device said they were no longer in severe pain at the end of 6 months — 55% reported ‘moderate’ pain and 36% reported a ‘mild’ level of pain.
For example, someone who started the study with a VAS pain level of 10 might report a 7 score after the first week. “That’s clinically significant, but 7 is still a pretty severe pain. After using the device for 6 months, their pain was down more to a level of 4 or 3, which is really pretty tolerable,” Staelin said.
“No one device or no one approach is going to be the panacea for everybody,” Staelin cautioned. “I would just say your probability of success is pretty high when using this device.”
The researchers also found that patients who reported improvement in pain also reported increased quality of life, better sleep, and physical improvements. Furthermore, 28% of the participants said they stopped using any analgesic medications and 16% stopped using other pain management therapies.
The ActiPatch has few adverse events and is relatively inexpensive, Staelin said. “The device costs $10 or $20 for a 7-day trial. It’s not a huge expense. I would think it’s worth a try.”
From Medscape Medical News. The study was published online on September 30 in Pain Research and Management.