High-frequency SCS Versus SCS in the Treatment of Diabetic Peripheral Neuropathic Pain
Recruiting now · Not applicable
Conditions studied: Painful Diabetic Peripheral Neuropathy
In brief
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.
Key facts
- Study ID
- NCT06158529
- Run by
- Fan BiFa
- People needed
- 1
- Starts
- 2025-01-06
- Expected to finish
- 2025-12-31
- Last updated by the study team
- 2025-02-25
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosed with diabetes, aged between 18 and 80 years old;
- Symmetrical pain in the distal lower extremities with or without dysesthesia;
- Duration of symptoms exceeding 6 months;
- Pain described as stabbing and/or electric shock-like and/or burning sensation;
- Abnormal Quantitative Sensory Testing (QST);
- Presence of hyperalgesia and allodynia;
- Absence of lower limb reflexes and muscle strength abnormalities;
- Normal MRI or CT scans without spinal canal stenosis or other spinal abnormalities.
You may not qualify if…
- Concurrent severe cardiovascular and cerebrovascular diseases;
- 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;
- Presence of radicular symptoms;
- Other spinal abnormalities, such as benign or malignant tumors, congenital abnormalities of the spine, spinal instability, etc.;
- Coexisting disorders of the coagulation system, malignant tumors, infections, and psychiatric or psychological disorders;
- Pregnancy.
Where it is running
- China-Japan Friendship Hospital — Beijing, China (enrolling)
Full record on ClinicalTrials.gov
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