JAMA Subcumes: High frequency (10kHz) spinal cord stimulation on patients with painful diabetic neuropathy
According to the World Health Organization, a total of 422 million adults in the world have diabetes, and their prevalence (8.5%) has almost doubled over the past 40 years. Diabetes can cause systemic damage, have a profound impact on health -related quality of life, and may threaten life. Diabetes peripheral neuropathy is a common complication, manifested as pain and other sensory disorders, including numbness, burning or tingling. About 20%of patients with diabetes will develop into painful diabetic neuropathy (PDN), which is a kind of underlying, potentially weak chronic neurological pain.
The current PDN therapy includes neurological pain drugs, such as Gaba spray, 5 -hydroxylidine -norepinephrine re -absorbing inhibitors, three -ring antidepressants, opioids and topical solutions. High -quality random clinical trials (RCT) show that the efficacy of these drugs is limited and the incidence of adverse reactions is high. Gaba spray diced drugs may increase the risk of respiratory suppression. This is a serious concern for patients taking opioids or potential respiratory disorders.
In 1996, it was first reported for non -pharmaceutical PDN treatment with spinal cord stimulation (SCS) equipment. Observation data shows that high-frequency (10-kHz) SCS provides substantial pain relief for PDN patients without feeling abnormal feeling required for other types of SCS. Based on this, some researchers have studied the prognosis of patients with 10kHz spinal cord stimulation (SCS) to improve refractory and painful diabetic neuropathy (PDN). The research results were recently published in Jama Neurol.
This forward-looking, multi-center, open label Senza-PDN random clinical trial compared traditional medical management (CMM) and 10 KHz SCS+CMM. Integrated in PDN patients who take Gaba spray drugs for 1 year or one year and at least 1 other patients with analgesia. The pain strength of the lower limbs is 5cm or 10cm visual simulation score (VAS). Mi calculation) is 45 or below, and the glycated hemoglobin (HBA1C) is 10%or less, and it is suitable for this operation. Participants registered from multiple locations in the United States from August 2017 to August 2019, including academic centers and community pain clinics. They were followed up for 6 months, and they could be selected at 6 months. Filtering 430 patients, 214 patients were excluded or refused to participate, and 216 patients were randomly grouped. In the 6 -month follow -up, 187 patients were evaluated.
The main ending of the pre -set is the percentage of VAS pain to relieve 50%or more or more and the baseline neurological defect. In accordance with the pre -stipulation in the analysis plan, layered testing of the endpoint. Measurement includes pain VAS, nervous system examination, health -related life quality (EUROQOL five -dimensional questionnaire) and HBA1C with more than 6 months.
Of the 216 random patients, 136 cases (63.0%) were men, with an average age of 60.8 (10.7). In addition, the median duration of diabetes and peripheral neuropathy is 10.9 (6.3-16.4) and 5.6 (3.0-10.1). 5 of the 94 patients with CMM group reached the main end of the intention to treat the crowd, and 75 of 95 patients with 10 KHz SCS+CMM groups. Two patients in the 10kHz SCS+CMM group had infection, and the infection rate was 2%. For the CMM group, the Pain VAS score is 7.0cm at the baseline and 6.9cm at 6 months. For the 10kHz SCS+CMM group, the average pain VAS score during the baseline was 7.6cm, and the average pain VAS score was 1.7cm at 6 months. When the researchers observed 6 months, 3 of the 92 patients in the CMM group and 52 of 84 patients in the 10 KHz SCS+CMM group were improved.
Regardless of the cause, chronic pain will have a negative impact on sleep quality. This is especially true for patients with symptoms that have deteriorated significantly at night. This study shows that 10kHzSCS can significantly improve the sleep of PDN patients. In addition, patients have improved in various quality of life -related life, indicating that this treatment has a wide impact on the life of patients.
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In short, patients who use high -frequency (10kHz) SCS can safely and effectively treat PDN difficulties. The evidence -based treatment guide should consider the positioning of 10 KHz SCS in continuous care. In practice, PDN patients who have insufficient reactions in conventional treatment should consider using 10kHz SCS.