Status:
RECRUITING
High-frequency SCS Versus SCS in the Treatment of Diabetic Peripheral Neuropathic Pain
Lead Sponsor:
Fan BiFa
Collaborating Sponsors:
Peking University Third Hospital
Xuanwu Hospital, Beijing
Conditions:
Painful Diabetic Peripheral Neuropathy
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 effi...
Detailed Description
The incidence rate of diabetes peripheral neuropathic pain (DPNP) is high, and there is no clear and effective treatment, which is a clinical problem to be solved urgently. Traditional spinal cord el...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT06158529
Start Date
January 6 2025
End Date
December 31 2025
Last Update
February 25 2025
Active Locations (1)
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1
China-Japan Friendship Hospital
Beijing, China