A new study found that spinal cord stimulation (SCS) that generates higher frequencies compared to traditional low-frequency systems may provide better effects and lesser paresthesias to patients. At present, treatments for chronic pain do not provide sufficient effectiveness and may even result in unwanted side effects. With this, the researchers of the new study aim to compare the long-term safety and efficacy of available SCS therapies to patients suffering from leg and back pain.
The experts of the parallel-arm, randomized and noninferiority research collated data from 198 study participants, who are experiencing both back and leg pains. The subjects were then randomized in a 1:1 ratio to a treatment group in 10 medical facilities that specialize in intensive pain therapies. The researchers conducted an initial temporary trial and determined a final group composed of 171 subjects, from the original 198 subjects, to be implanted by an SCS device. Being a responder to the experiments means experiencing back pain reduction by 50 percent or more, provided that there are no other neurological impairments present associated with stimulation.
The findings of the study, published in the Journal of the American Society of Anesthesiologists, show that 84.5 percent and 83.1 percent of participants, who were implanted with a 10-kHz high-frequency therapy (HF10 therapy) were considered responders for back pain and leg pain respectively. Meanwhile, traditional SCS yielded a responder rate of 43.8 percent for back pain and 55.5 percent for leg pain. These results were assessed after three months of SCS system implantation. After 12 months, the HF10 therapy continued to waver past the traditional SCS in terms of providing back and leg pain relief. None of the HF10 patients complained of paresthesias. Overall, the satisfaction rate of HF10 was 55 percent, which is higher than the 32 percent of patients who reported satisfaction over the traditional SCS.
"This is the first long-term study to compare the safety and effectiveness of high frequency and traditional SCS therapy for back and leg pain," says Dr. Leonardo Kapural, a professor of anesthesiology at Wake Forest University School of Medicine. As chronic pain has long been debilitating patients and medicines provide minimal relief and side effects, the emergence of high frequency SCS is innovative and exciting news for patients, he adds.
SCS is the most common implantable device that acts as a neurostimulator to alleviate pain syndromes. According to the American Association of Neurological Surgeons, about 50,000 devices are implanted all around the world every year. The US Food and Drug Administration (FDA) has widely accepted this therapy as treatment for chronic trunk and limbs pain.
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