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โ† Trials
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High-frequency SCS Versus SCS in the Treatment of Diabetic Peripheral Neuropathic Pain

RecruitingNAAges 18 Years - 80 YearsAllFan BiFa
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In plain words

What the trial is, and whether it could suit you

Application of High-Frequency Spinal Cord Stimulation (HF-SCS) in the Treatment of Painful Diabetic Peripheral Neuropathy (PDPN): A multicenter, randomized controlled study comparing its clinical efficacy with traditional spinal cord stimulation for PDPN. The study aims to observe the impact of HF-SCS on the neurological function and microcirculation of PDPN patients, elucidating the correlation between the underlying diabetes and the efficacy of HF-SCS therapy on PDPN. The goal is to enhance the treatment standards for PDPN, improve the quality of life for this population, and overall treatment outcomes. Simultaneously, the study aims to contribute evidence-based medicine for the mechanistic exploration of PDPN.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Diagnosed with diabetes, aged between 18 and 80 years old; 2. Symmetrical pain in the distal lower extremities with or without dysesthesia; 3. Duration of symptoms exceeding 6 months; 4. Pain described as stabbing and/or electric shock-like and/or burning sensation; 5. Abnormal Quantitative Sensory Testing (QST); 6. Presence of hyperalgesia and allodynia; 7. Absence of lower limb reflexes and muscle strength abnormalities; 8. Normal MRI or CT scans without spinal canal stenosis or other spinal abnormalities. Exclusion Criteria: 1. Concurrent severe cardiovascular and cerebrovascular diseases; 2. History of lumbar spine surgery, trauma, or spinal canal stenosis within the past 6 months, or a history of lumbar spine surgery, trauma, or spinal canal stenosis that would impact the SCS surgery and pain assessment in this study; 3. Presence of radicular symptoms; 4. Other spinal abnormalities, such as benign or malignant tumors, congenital abnormalities of the spine, spinal instability, etc.; 5. Coexisting disorders of the coagulation system, malignant tumors, infections, and psychiatric or psychological disorders; 6. Pregnancy.
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What it tests

  • spinal cord stimulator
  • high frequency spinal cord stimulation
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Where

1 site
China-Japan Friendship Hospital
Beijing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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