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A Sympathetic Ganglion, High-voltage Pulsed Radiofrequency Ablation of Peripheral Neuralgia

Primary Purpose

Diabetic Foot

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Pulsed radio frequency therapy
sham operation
Sponsored by
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subjects voluntarily participate in the study and sign the informed consent form; The age is between 18 (inclusive) and 85 (inclusive), regardless of gender; Body mass index (BMI) ≤ 45; Clinically diagnosed diabetes foot with moderate and severe pain in peripheral nerve of affected limb (defined as NRS score ≥ 4), the course of disease lasts for more than 12 months, and has been treated with clinical routine standard drugs (mecobalamin α- Lipoic acid, sodium valproate, carbamazepine, gabapentin/pregabalin, etc.) symptoms still exist at least 6 months later; Glycated hemoglobin<8%; Not participating in the drug/medical device test within 3 months before the test; Exclusion Criteria: Patients who are in poor condition and cannot objectively describe symptoms or cooperate to complete the questionnaire score Ulcer is red and swollen, or active inflammatory infection; The affected limb has lesions such as blackening and gangrene of the toe skin; Those suffering from severe respiratory and cardiovascular diseases, liver and kidney insufficiency, and malignant tumors; Breast-feeding and pregnant women, or subjects with pregnancy plan within 1 month after the trial (also including male subjects); The daily dose of opioids is more than 120mg (different drug doses are converted into 120mg morphine sustained-release tablets); People with allergic diseases and allergic constitution; Have a history of drug abuse or drug addiction; There are contraindications to pulsed radio frequency therapy;

Sites / Locations

  • Shanghai XINHUA Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A group

B group

Arm Description

First receive pulse radio frequency treatment and then receive sham operation treatment

First receive sham operation treatment and then receive pulse radio frequency treatment

Outcomes

Primary Outcome Measures

Numeric Rating Scale
Numeric Rating Scale is the most widely used one-dimensional assessment scale,The higher the number, the more severe the pain

Secondary Outcome Measures

Full Information

First Posted
March 15, 2023
Last Updated
April 14, 2023
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05831059
Brief Title
A Sympathetic Ganglion, High-voltage Pulsed Radiofrequency Ablation of Peripheral Neuralgia
Official Title
A Randomized, Controlled, Double-blind, Multicenter, Sympathetic Ganglion, High-voltage Pulsed Radiofrequency Ablation of Peripheral Neuralgia in Patients With Diabetic Foot
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 12, 2022 (Actual)
Primary Completion Date
November 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The Sham Operation Group was used as control, the patients were assessed with the Digital Rating Scale (NRS) , the quality of life-related scale (Euro Qol) , clinical outcome measures: physician's overall impression of changes in pain (CGIC) and patient's overall impression change scale (PGIC) , skin temperature measurement, toe Oxygenation measurement, and anxiety and depression scores (Gad-7, Phq-9) , objective: to evaluate the efficacy and safety of high voltage pulsed radiofrequency in the treatment of peripheral neuralgia in patients with diabetic foot.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A group
Arm Type
Experimental
Arm Description
First receive pulse radio frequency treatment and then receive sham operation treatment
Arm Title
B group
Arm Type
Active Comparator
Arm Description
First receive sham operation treatment and then receive pulse radio frequency treatment
Intervention Type
Radiation
Intervention Name(s)
Pulsed radio frequency therapy
Intervention Description
Pulse Radio Frequency mode is a high voltage and low temperature Radio Frequency mode formed by discontinuous and pulsed current around nerve tissue
Intervention Type
Other
Intervention Name(s)
sham operation
Intervention Description
The means to achieve double-blind treatment had no practical effect on the subjects
Primary Outcome Measure Information:
Title
Numeric Rating Scale
Description
Numeric Rating Scale is the most widely used one-dimensional assessment scale,The higher the number, the more severe the pain
Time Frame
up to 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects voluntarily participate in the study and sign the informed consent form; The age is between 18 (inclusive) and 85 (inclusive), regardless of gender; Body mass index (BMI) ≤ 45; Clinically diagnosed diabetes foot with moderate and severe pain in peripheral nerve of affected limb (defined as NRS score ≥ 4), the course of disease lasts for more than 12 months, and has been treated with clinical routine standard drugs (mecobalamin α- Lipoic acid, sodium valproate, carbamazepine, gabapentin/pregabalin, etc.) symptoms still exist at least 6 months later; Glycated hemoglobin<8%; Not participating in the drug/medical device test within 3 months before the test; Exclusion Criteria: Patients who are in poor condition and cannot objectively describe symptoms or cooperate to complete the questionnaire score Ulcer is red and swollen, or active inflammatory infection; The affected limb has lesions such as blackening and gangrene of the toe skin; Those suffering from severe respiratory and cardiovascular diseases, liver and kidney insufficiency, and malignant tumors; Breast-feeding and pregnant women, or subjects with pregnancy plan within 1 month after the trial (also including male subjects); The daily dose of opioids is more than 120mg (different drug doses are converted into 120mg morphine sustained-release tablets); People with allergic diseases and allergic constitution; Have a history of drug abuse or drug addiction; There are contraindications to pulsed radio frequency therapy;
Facility Information:
Facility Name
Shanghai XINHUA Hospital
City
Shanghai
Country
China

12. IPD Sharing Statement

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A Sympathetic Ganglion, High-voltage Pulsed Radiofrequency Ablation of Peripheral Neuralgia

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