Comparing high-frequency spinal cord stimulation to traditional methods for diabetic nerve pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• China-Japan Friendship Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: BiFa Fan, master
• Email: Lichen1616@outlook.com
• Phone: 18811358829

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.