High-frequency Electrical Spinal Cord Stimulation Versus Electrical Spinal Cord Stimulation in the Treatment of Diabetic Peripheral Neuropathic Pain

Painful Diabetic Peripheral Neuropathy Clinical Trial

Official title:

A Multicentre Clinical Study of High-frequency Electrical Spinal Cord Stimulation Versus Electrical Spinal Cord Stimulation in the Treatment of Diabetic Peripheral Neuropathic Pain

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06158529
• Other study ID #: SF-2022-1-4061
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 27, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: China-Japan Friendship Hospital
• Contact: BiFa Fan, master
• Phone: 18811358829
• Email: Lichen1616[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1
• Est. completion date: December 31, 2025
• Est. primary completion date: November 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neuralgia
• Painful Diabetic Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Fan BiFa	Beijing Tian Tan Hospital, Civil Aviation General Hospital, Peking University Third Hospital, Shenzhen Nanshan Hospital, Xuanwu Hospital, Beijing

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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