Transcutaneous Vagus Nerve Stimulation As a Pain Modulator in Knee Osteoarthritis

May 18, 2022 updated by: Gehad Gamal Elsehrawy, Suez Canal University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The included study population is 68.

  • Group (1): (tVNS group): This group of study subjects will include 34 patients of knee osteoarthritis and will be subjected to tVNS.
  • Group (2): (sham group): This group of study subjects will include 34 patients of knee osteoarthritis and will be subjected to sham treatment.

DESCRIPTION OF THE TECHNIQUE

Active treatment:

Afferents of the Auricular branch of vagus nerve 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). The electrode was placed in the left cymba concha with direct contact on the skin after cleaning with an alcohol swab. 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 10 Hz.

Sham procedure:

For sham-t-VNS device was turned 180°, stimulating the outer earlobe which does not contain fibers of the ABVN. A similar protocol as for active stimulation was used.

All participants initially will be evaluated before and after intervention and 3 months after the end of the sessions by the following:

OUTCOME MEASURES AND ASSESSMENT QUESTIONNAIRES

  1. Visual analogue scale (VAS)
  2. PainDETECT questionnaire
  3. DN4 questionnaire
  4. Radiological Imaging
  5. Knee injury and Osteoarthritis Outcome Score
  6. Hospital Anxiety Depression Scale
  7. Physical Function Tests
  8. Quantitative sensory testing
  9. The Central Sensitization Inventory

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Ismailia, Egypt, 41522
        • Suez Canal University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Both genders.
  • Adult over 18 years.
  • People who were diagnosed.
  • Reported pain on visual analogue scale (VAS)>4/10.
  • Able to understand the informed consent.

Exclusion Criteria:

  • Peptic ulcer
  • Pace maker
  • Asthma or severe chronic obstructive pulmonary disease
  • Pregnancy.
  • Cellulites, skin ulceration at area of therapy application.
  • Inability to fulfill follow-up criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
SHAM_COMPARATOR: sham Transcutaneous Vagus Nerve Stimulation
For sham-t-VNS device was turned 180°, stimulating the outer earlobe which does not contain fibers of the ABVN. A similar protocol as for active stimulation was used.
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).
ACTIVE_COMPARATOR: 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). The electrode was placed in the left cymba concha with direct contact on the skin after cleaning with an alcohol swab. 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 10 Hz.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
visual analogue scale
Time Frame: 3 months
to describe pain on 0 to 10 scale
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: 3 months
for function and activity assessment
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suez Canal University

Investigators

  • Study Director: Mohammed A Hefny, MD, professor of physical medicine, rheumatology and rehabilitation
  • Study Director: Nashwa K Elshaarawy, MD, Assisstant professor of physical medicine, rheumatology and rehabilitation
  • Study Director: Nermeen H Abdelmoneam, Ph.D, lecturer of physical medicine, rheumatology and rehabilitation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 5, 2019

Primary Completion (ACTUAL)

July 5, 2021

Study Completion (ACTUAL)

May 5, 2022

Study Registration Dates

First Submitted

May 18, 2022

First Submitted That Met QC Criteria

May 18, 2022

First Posted (ACTUAL)

May 24, 2022

Study Record Updates

Last Update Posted (ACTUAL)

May 24, 2022

Last Update Submitted That Met QC Criteria

May 18, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3905

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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