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

NCT ID: NCT05831059

Last Updated: 2024-05-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-12
• Study Completion Date: 2024-12-15

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.

Conditions

Diabetic Foot

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

A group

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

Group Type: EXPERIMENTAL

Pulsed radio frequency therapy

Intervention Type: RADIATION

Pulse Radio Frequency mode is a high voltage and low temperature Radio Frequency mode formed by discontinuous and pulsed current around nerve tissue

sham operation

Intervention Type: OTHER

The means to achieve double-blind treatment had no practical effect on the subjects

B group

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

Group Type: ACTIVE_COMPARATOR

Pulsed radio frequency therapy

Intervention Type: RADIATION

Pulse Radio Frequency mode is a high voltage and low temperature Radio Frequency mode formed by discontinuous and pulsed current around nerve tissue

sham operation

Intervention Type: OTHER

The means to achieve double-blind treatment had no practical effect on the subjects

Interventions

Pulsed radio frequency therapy

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: RADIATION

sham operation

The means to achieve double-blind treatment had no practical effect on the subjects

Intervention Type: OTHER

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Ke Ma

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai XINHUA Hospital

Shanghai, , China

Countries

China

Other Identifiers

XH-23-004

Identifier Type: -

Identifier Source: org_study_id