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

NCT06158529 | Recruiting DMC

• 1 other identifier: SF-2022-1-4061
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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 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

Painful Diabetic Peripheral Neuropathy

Keywords

spinal cord stimulation

Outcome Measures

Primary Outcomes (1)

• treatment effectiveness

  The treatment effectiveness is assessed based on the reduction of Numeric Rating Scale (NRS) scores for pain three months after treatment compared to before treatment. Specifically, a decrease of ≥50% in the pain NRS score \[(NRS score at 3 months post-treatment - NRS score before treatment) / NRS score before treatment\] ≥ 50% is considered the criterion for treatment effectiveness

  3months

Study Arms (2)

spinal cord stimulation

ACTIVE COMPARATOR

Traditional spinal cord electrical stimulation

Device: spinal cord stimulator

high frequency spinal cord stimulation

EXPERIMENTAL

High frequency SCS (HF-SCS) technology can treat chronic pain without relying on the tingling sensation

Device: high frequency spinal cord stimulation

Interventions

spinal cord stimulator DEVICE

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

spinal cord stimulation

high frequency spinal cord stimulation DEVICE

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.

high frequency spinal cord stimulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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.

Sponsors & Collaborators

• Fan BiFa: lead
• Peking University Third Hospital: collaborator
• Xuanwu Hospital, Beijing: collaborator
• Civil Aviation General Hospital: collaborator
• Shenzhen Sixth People's Hospital: collaborator
• Beijing Tiantan Hospital: collaborator

Study Sites (1)

China-Japan Friendship Hospital

Beijing, China

RECRUITING

Study Officials

• BiFa Fan, master

  China-Japan Friendship Hospital

  STUDY CHAIR

Central Study Contacts

BiFa Fan, master

CONTACT

18811358829; Lichen1616@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: China-Japan Friendship Hospital

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 6, 2023
• Study Start: January 6, 2025
• Primary Completion: October 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)