The chronic pain therapy ActiPatch, developed by BioElectronics Corp., has reached positive results in a seven-day trial evaluating its efficacy in chronic pain management. Results from the trial of the pulsed shortwave device have been released in a report entitled “A UK registry study of the effectiveness of a new over-the-counter chronic pain therapy,” published in Pain Management.
Management of chronic musculoskeletal pain often requires pharmacologic and nonpharmacologic therapies that have been shown to be ineffective, poorly tolerated, or inadequate in many individuals. Common causes for chronic pain include rheumatoid arthritis, osteoarthritis, injuries, and fibromyalgia.
ActiPatch is an alternative, easy-to-use, low power, and noninvasive therapy device for musculoskeletal pain. It requires, the researchers noted, two basic requirements for use: activating the device through an on/off switch and affixing it via flexible circular wraps or medical tape to the body area causing pain. This therapy is already available over-the-counter in the U.K. and has been previously shown to reduce postoperative pain and need for pain medication in breast augmentation patients, as well as positive relief effects on plantar fasciitis and osteoarthritis of the knee.
To evaluate its efficacy at a large scale, researchers conducted a seven-day trial equal to the number of days the device can maintain its battery power in continuous use, as recommended. The trial included responses from 5,002 patients of the 44,000 who received the ActiPatch device. Most participants suffered from chronic pain due to osteoarthritis (31%), rheumatoid arthritis (15%), and fibromyalgia (15%). Efficacy and overall benefit was measured through the visual analogue scale (VAS) pain reduction, a qualitative measurement included in the questionnaire that requires a minimum of 2 or greater visual analogue scale (VAS) point reduction (0–10 scale).
Results showed that VAS at baseline was of 8.02, with participants reporting use of analgesic tablets (84%), transcutaneous electrical nerve stimulation (20%), topical (32%), heat wraps (27%), and physical therapy (19%). The use of ActiPatch generated a 2-point improvement on the VAS in 65% of participants, with an average 57% of pain reduction. The effectiveness of pain relief decreased with pain duration: participants suffering from pain for more than 20 years reported an average pain decrease of 50%, while participants suffering from pain for less than two years reported an average of 60% in pain reduction. Gender differences were also observed, with females reporting a higher baseline VAS pain and higher pain relief than men, 8.11 vs. 7.79 and 67% vs. 59%, respectively.
The majority of participants (81%) required a maximum of three days to experience pain relief. Furthermore, a second three-month follow-up assessment was sent to the 71% who reported an intention to purchase ActiPatch, with long-term pain relief reported by 93% of users. Ongoing assessment reveals that 84% of participants report a moderate to great improvement of quality of life (data from 658 responses). However, researchers believe that more assessment trials and further investigation needs to be preformed to understand ActiPatch’s mechanism of action in order to validate it, exclude placebo effects, and confirm its potential in pain relief therapy.
“Further research and refinement of the technology may well enhance its clinical effect and offer a safe alternative chronic musculoskeletal pain therapy for many individuals in the years ahead,” the researchers concluded.