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RecruitingNot ApplicableNCT06158529

High-frequency SCS Versus SCS in the Treatment of Diabetic Peripheral Neuropathic 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

Sponsor

Fan BiFa

Enrollment

1 participants

Start Date

Jan 6, 2025

Study Type

INTERVENTIONAL

Conditions

Painful Diabetic Peripheral Neuropathy

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 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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria8

  • 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 Criteria6

  • 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.

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Interventions

DEVICEspinal cord stimulator

A spinal cord stimulator is an implanted device that sends low levels of electricity directly into the spinal cord to relieve pain.

DEVICEhigh frequency spinal cord stimulation

A spinal cord stimulator is an implanted device that sends low levels and high frequency of electricity directly into the spinal cord to relieve pain.

Locations(1)

China-Japan Friendship Hospital

Beijing, China

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NCT06158529