The Therapeutic Effect of Low-intensity Focused Ultrasound on Painful Diabetic Peripheral Neuropathy

NCT05624762 | Unknown

• 1 other identifier: DPN-China2022
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetic painful peripheral neuropathy (DPN) constitutes a serious threat to the outcomes of patients with diabetes. Yet, the treatments for targeting the underlying nerve damage and relieving pain are limited. The low-intensity focused ultrasound (LIFU) has been demonstrated to regulate neuronal activity without any concomitant tissue damage. Studies in animal models have shown that LIFU could protect nerve cells against inflammation and oxidative stress, as well as stimulate neurotrophic factor production. In humans, LIFU has been reported to be effective in relieving peripheral neurogenic pain caused by carpal tunnel syndrome and chemotherapy drugs. Thus, we aim to design a randomized controlled double-blind study by using LIFU. The primary endpoint is the patient's pain score (NRS), and the secondary endpoints include Neuropathy Symptom Score (NSS) and Neuropathy Deficit Score (NDS). Through this study, we anticipate establishing a new method for managing painful DPN.

Conditions

Painful Diabetic Neuropathy

Keywords

Painful Diabetic Neuropathy; low-intensity focused ultrasound

Outcome Measures

Primary Outcomes (1)

• pain score

  the pain score is evaluated using a numeric pain rating (0-10) scale (NRS)

  7 days

Secondary Outcomes (2)

• Neuropathy Symptom Score (NSS)

  7 days

• Neuropathy Deficit Score (NDS)

  7 days

Other Outcomes (2)

• The motor nerve conduction velocity (MNCS)

  7 days

• The sensory nerve conduction velocity (SNCS)

  7 days

Study Arms (2)

LIFU group

ACTIVE COMPARATOR

receive LIFU therapy

Device: Low-Intensity Focused Ultrasound (LIFU)

Control group

SHAM COMPARATOR

receive sham LIFU therapy

Device: Sham Low-Intensity Focused Ultrasound

Interventions

Low-Intensity Focused Ultrasound (LIFU) DEVICE

LIFU device (LCA200; Chongqing Haifu Medical Technology Co., Ltd., Chongqing, China).

LIFU group

Sham Low-Intensity Focused Ultrasound DEVICE

Sham Low-Intensity Focused Ultrasound

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 20 and 80 years
• having diabetes based on the criteria of the World Health Organization (WHO 1999)
• Having diabetic painful neuropathy for more than 1 month but less than 5 years
• no alcohol addiction (consumption\<140g/week in men and \<70g/week in women)
• no history of cerebral infarction/hemorrhage or other known nervous system disease
• no active infections in the skin

You may not qualify if:

• having abnormalities in levels of Vitamin B12, Hemoglobin, and TSH.
• HbA1C\>10%
• having moderate or severe hepatic and renal dysfunctions.

Sponsors & Collaborators

• Chongqing Medical University: lead

Study Sites (1)

the First Affiliated Hospital of Chongqing Medical University

Chongqing, 400016, China

RECRUITING

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Qian Ge, Professor

  Department of Endocrinology, the First Affiliated Hospital of Chongqing Medical University

  STUDY DIRECTOR

Central Study Contacts

Qian Ge, Professor

CONTACT

+8619946802662; geqian@hospital.cqmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: November 22, 2022
• Study Start: July 7, 2022
• Primary Completion: December 31, 2023
• Study Completion: January 31, 2024
• Last Updated: November 22, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)