Actively Recruiting
High-frequency SCS Versus SCS in the Treatment of Diabetic Peripheral Neuropathic Pain
Led by Fan BiFa · Updated on 2025-02-25
1
Participants Needed
1
Research Sites
51 weeks
Total Duration
On this page
Sponsors
F
Fan BiFa
Lead Sponsor
P
Peking University Third Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
High-frequency SCS Versus SCS in the Treatment of Diabetic Peripheral Neuropathic Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Concurrent severe cardiovascular and cerebrovascular diseases
- History of lumbar spine surgery, trauma, or spinal canal stenosis within the past 6 months, or a history affecting SCS surgery and pain assessment
- Presence of radicular symptoms
- Other spinal abnormalities such as tumors, congenital abnormalities, or spinal instability
- Coexisting disorders of coagulation, malignant tumors, infections, or psychiatric/psychological disorders
- Pregnancy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
China-Japan Friendship Hospital
Beijing, China
Actively Recruiting
Research Team
B
BiFa Fan, master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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