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

Not Applicable

Active, not recruiting

• Conditions: Diabetic Foot
• Interventions: Radiation: Pulsed radio frequency therapy; Other: sham operation

• Registration Number: NCT05831059
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-12
• Study First Submitted: 2023-03-15
• Study First Submitted QC: 2023-04-14
• Study First Posted: 2023-04-26
• Primary Completion: 2023-11-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-05-28
• Last Update Posted: 2024-05-30
• Study Completion: 2024-12-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A group	sham operation	First receive pulse radio frequency treatment and then receive sham operation treatment
B group	Pulsed radio frequency therapy	First receive sham operation treatment and then receive pulse radio frequency treatment
B group	sham operation	First receive sham operation treatment and then receive pulse radio frequency treatment
A group	Pulsed radio frequency therapy	First receive pulse radio frequency treatment and then receive sham operation treatment

Primary Outcome Measures

Name	Time	Method
Numeric Rating Scale	up to 4 months	Numeric Rating Scale is the most widely used one-dimensional assessment scale，The higher the number, the more severe the pain

Trial Locations

Locations (1)

Shanghai XINHUA Hospital; 🇨🇳 Shanghai, China