MedTrace Logo

Transcutaneous Vagus Nerve Stimulation As a Pain Modulator in Knee Osteoarthritis

NCT05387135 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2022-05-24

No results posted yet for this study

Summary

a single-blinded, randomized clinical trial, 68 patients divided into 2 groups: active and sham treatment. Afferents of the Auricular branch of vagus nerve are stimulated using a transcutaneous Vagus Nerve Stimulation device (TENS 7000TM). The electrode was placed in the left cymba concha with direct contact on the skin. The stimulation for both groups will last for 30 minutes once a day for 3 days per week for 12 weeks. The amplitude of the output current was between 0.25-2.0 mA as tolerated and 250 µs width at 25 Hz. All participants initially will be evaluated before and after intervention and 3 months after the end of the sessions.

Conditions

Interventions

DEVICE

Transcutaneous Vagus Nerve Stimulation

Afferents of the Auricular branch of vagus nerve (ABVN) were stimulated using a t-VNS device (TENS 7000TM made by Roscoe Medical Inc., will be used. TENS 7000TM device was labeled as nerve stimulator and low-risk medical device (Instruction manual for TENS 7000).

Sponsors & Collaborators

  • Suez Canal University

    lead OTHER

Principal Investigators

  • Mohammed A Hefny, MD · professor of physical medicine, rheumatology and rehabilitation

  • Nashwa K Elshaarawy, MD · Assisstant professor of physical medicine, rheumatology and rehabilitation

  • Nermeen H Abdelmoneam, Ph.D · lecturer of physical medicine, rheumatology and rehabilitation

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-05
Primary Completion
2021-07-05
Completion
2022-05-05

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05387135 on ClinicalTrials.gov