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

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.

Study Overview

• Status: Recruiting
• Conditions: Painful Diabetic Peripheral Neuropathy
• Intervention / Treatment: Device: spinal cord stimulator; Device: high frequency spinal cord stimulation

Detailed Description

The incidence rate of diabetes peripheral neuropathic pain (DPNP) is high, and there is no clear and effective treatment, which is a clinical problem to be solved urgently.

Traditional spinal cord electrical stimulation (SCS) has the potential to treat DPNP, and its efficacy depends on the tingling sensation generated by the electrical stimulation covering the painful area of the patient. The neurological dysfunction of DPNP patients and the defects of traditional SCS lead to unsatisfactory therapeutic effects.

The emerging high-frequency SCS (HF-SCS) technology can treat chronic pain without relying on tingling sensation. Multiple evidence shows that HF-SCS has better long-term efficacy in treating chronic neuropathic pain than traditional SCS.

Our research group has also preliminarily confirmed the effectiveness and safety of HF-SCS in treating DPNP.

Therefore, this study intends to use a multicenter prospective randomized controlled clinical research method to explore the superiority of HF-SCS in treating DPNP compared to traditional SCS, and establish a standardized diagnosis and treatment platform database for DPNP in Beijing.

This project will provide high-level evidence-based medicine for the treatment of DPNP with HF-SCS, and also provide clinical big data support for the standardized diagnosis and treatment of DPNP in the future.

On the basis of medical engineering integration, an innovative remote control system is applied to achieve real-time adjustment and precise regulation of SCS treatment parameters.

• Study Type: Interventional
• Enrollment (Estimated): 1
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: BiFa Fan, master; Phone Number: 086 18811358829; Email: Lichen1616@outlook.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • China-Japan Friendship Hospital
    • Contact: Peng Mao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: spinal cord stimulation; Traditional spinal cord electrical stimulation	Device: spinal cord stimulator; A spinal cord stimulator is an implanted device that sends low levels of electricity directly into the spinal cord to relieve pain.
Experimental: high frequency spinal cord stimulation; High frequency SCS (HF-SCS) technology can treat chronic pain without relying on the tingling sensation	Device: high 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Fan BiFa
• Collaborators: Beijing Tiantan Hospital; Peking University Third Hospital; Xuanwu Hospital, Beijing; Shenzhen Sixth People's Hospital; Civil Aviation General Hospital
• Investigators: Study Chair: BiFa Fan, master, China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2025
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 28, 2023
• First Submitted That Met QC Criteria: November 28, 2023
• First Posted (Actual): December 6, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 23, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: spinal cord stimulation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Neuromuscular Diseases; Neuralgia; Peripheral Nervous System Diseases
• Other Study ID Numbers: SF-2022-1-4061

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Sharing Time Frame: 2023/1/1-2025/12/31

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No