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

NCT ID: NCT06158529

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-06
• Study Completion Date: 2025-12-31

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.

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.

Conditions

Painful Diabetic Peripheral Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

spinal cord stimulation

Traditional spinal cord electrical stimulation

Group Type: ACTIVE_COMPARATOR

spinal cord stimulator

Intervention Type: DEVICE

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

high frequency spinal cord stimulation

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

Group Type: EXPERIMENTAL

high frequency spinal cord stimulation

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: collaborator

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: collaborator

Civil Aviation General Hospital

OTHER

Sponsor Role: collaborator

Shenzhen Sixth People's Hospital

OTHER

Sponsor Role: collaborator

Beijing Tiantan Hospital

OTHER

Sponsor Role: collaborator

Fan BiFa

OTHER

Sponsor Role: lead

Responsible Party

Fan BiFa

China-Japan Friendship Hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

BiFa Fan, master

Role: STUDY_CHAIR

China-Japan Friendship Hospital

Locations

China-Japan Friendship Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

BiFa Fan, master

Role: CONTACT

Lichen1616@outlook.com

18811358829 ext. 086

Facility Contacts

Peng Mao

Role: primary

Other Identifiers

SF-2022-1-4061

Identifier Type: -

Identifier Source: org_study_id