A preprogrammed, nomad, easy-to-use, transcutaneous electrical nerve stimulation (TENS) device was well tolerated and provided rapid and lasting pain decrease in women with primary dysmenorrhea (PD), according to a study published in the journal Progrés en Urologie.
The randomized, double-blind study found a 53% decrease in menstrual pain during the first two applications of the TENS (Laboratoires Urgo Healthcare, France) compared to a 5% reduction with the dummy device (SHAM).
“The study’s TENS device is capable of replacing or being combined with analgesics in the management of PD,” said principal investigator Martine Guy, MD, medical director at Urgo Research Innovation and Development in Chenôve, France.
Analgesics and/or nonsteroidal anti-inflammatory drugs (NSAIDs) are generally recommended as first-line treatments for PD, “but these products cause side effects that limit their use,” Guy told Contemporary OB/GYN. “Women are looking for non-pharmacological solutions.”
The efficacy of TENS in significantly reducing menstrual pain has been widely demonstrated, according to Guy, by stimulating large diameter Aß proprioceptive nerve fibers in the skin without activating the nociceptive fibers.
The study was conducted in Dijon, the capital city of the Burgundy region in eastern France, between February and September 2020. A total of 40 women were recruited, aged 28 to 43, who had suffered from PD for an average of 13.5 years, and requiring analgesics and/or NSAIDs consumption.
Following a cross-over design, women were equally randomized to the TENS for up to six daily applications at home, lasting 30 minutes each for an average of 3 days during the menstrual cycle, followed by SHAM with the same protocol; or conversely SHAM then TENS, again with the same protocol.
Participants self-applied the device to the abdominal or lumbar region, depending on the pain location.
Besides demonstrating a significant decrease in menstrual pain compared to SHAM, the TENS device achieved rapid relief – in less than 20 minutes in 74% of all applications -- and the effect lasted on average more than 7 hours.
Analgesic consumption also decreased by 93% with the TENS device.
Overall, seven of the 40 women reported a total of 10 non-serious adverse events, two of which could be related to TENS.
“The large reduction in pain with TENS and the rapidity of the analgesic effect is comparable to that described in the literature and was thus expected,” Guy said. “But while several studies conducted in subjects with chronic pain have shown a peak effect of TENS when the device is in use or immediately after stopping stimulation, the persistence of the effect in our study came as a surprise.”
The duration of pain relief likely influenced the decrease in consumption of analgesics, according to Guy.
The investigators were also surprised to learn that 87% of the women spontaneously used the TENS device during domestic tasks, 71% at work and 39% while shopping.
The French government recently launched a national strategy to treat endometriosis, “so we have added a TENS program for abdominal and pelvic chronic pain, including endometriosis,” Guy said.
The technology has very few contraindications, according to Guy, but can induce local reactions, including skin irritation at the site of application, or allergic reactions to the components of the gel which form the interface between the device and the skin and allows for the transmission of the electric power.
“New non-pharmacological analgesic solutions bring hope for a better quality of life for millions of girls and women,” Guy said.
Guy is an employee of Laboratoires Urgo Healthcare.