Comparing high-frequency spinal cord stimulation to traditional methods for diabetic nerve pain
A Multicentre Clinical Study of High-frequency Electrical Spinal Cord Stimulation Versus Electrical Spinal Cord Stimulation in the Treatment of Diabetic Peripheral Neuropathic Pain
This study tests if high-frequency spinal cord stimulation can help people with painful diabetic nerve pain more effectively than traditional methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | China-Japan Friendship Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06158529 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of high-frequency spinal cord stimulation (HF-SCS) compared to traditional spinal cord stimulation (SCS) in treating painful diabetic peripheral neuropathy (PDPN). It is a multicenter, randomized controlled trial that aims to assess the impact of HF-SCS on neurological function and microcirculation in patients suffering from PDPN. The research seeks to establish a standardized treatment platform and provide evidence-based insights into the efficacy of HF-SCS, potentially improving treatment standards and patient quality of life.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 80 diagnosed with diabetes and experiencing specific types of neuropathic pain in their lower extremities for over six months.
Not a fit: Patients with severe cardiovascular or cerebrovascular diseases, recent lumbar spine surgery, or other spinal abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a more effective treatment option for patients suffering from painful diabetic peripheral neuropathy.
How similar studies have performed: Previous studies have shown promising results for high-frequency spinal cord stimulation in treating chronic neuropathic pain, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing
- China-Japan Friendship Hospital — Beijing, China (Recruiting)
Study contacts
- Study coordinator: BiFa Fan, master
- Email: Lichen1616@outlook.com
- Phone: 18811358829
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.