spinal cord stimulatorhigh frequency spinal cord stimulation
spinal cord stimulator: A spinal cord stimulator is an implanted device that sends low levels of electricity directly into the spinal cord to relieve pain.
high frequency spinal cord stimulation: A spinal cord stimulator is an implanted device that sends low levels and high frequency of electricity directly into the spinal cord to relieve pain.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
treatment effectiveness — 3months The treatment effectiveness is assessed based on the reduction of Numeric Rating Scale (NRS) scores for pain three months after treatment compared to before treatment. Specifically, a decrease of ≥50% in the pain NRS score \[(NRS score at 3 months post-treatment - NRS score before treatment) / NRS score before treatment\] ≥ 50% is considered the criterion for treatment effectiveness
Trial sites (1)
Facility
City
Region
Status
China-Japan Friendship Hospital
Beijing
China
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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