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

NCT05831059 | Active Not Recruiting DMC

• 1 other identifier: XH-23-004
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Numeric Rating Scale

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

  up to 4 months

Study Arms (2)

A group

EXPERIMENTAL

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

Radiation: Pulsed radio frequency therapy; Other: sham operation

B group

ACTIVE COMPARATOR

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

Radiation: Pulsed radio frequency therapy; Other: sham operation

Interventions

Pulsed radio frequency therapy RADIATION

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

A group; B group

sham operation OTHER

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

A group; B group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai XINHUA Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: April 26, 2023
• Study Start: December 12, 2022
• Primary Completion: November 15, 2023
• Study Completion: December 15, 2024
• Last Updated: May 30, 2024

Record last verified: 2024-04

Locations

CN (1)