Transcutaneous Vagus Nerve Stimulation As a Pain Modulator in Knee Osteoarthritis

NCT05387135 | Completed

• 1 other identifier: 3905
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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

Knee Osteoarthritis

Keywords

Vagus nerve stimulation, knee osteoarthritis

Outcome Measures

Primary Outcomes (1)

• visual analogue scale

  to describe pain on 0 to 10 scale

  3 months

Secondary Outcomes (1)

• Knee injury and Osteoarthritis Outcome Score (KOOS)

  3 months

Study Arms (2)

sham Transcutaneous Vagus Nerve Stimulation

SHAM COMPARATOR

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

Transcutaneous Vagus Nerve Stimulation

ACTIVE COMPARATOR

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

Interventions

Transcutaneous Vagus Nerve Stimulation DEVICE

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).

Transcutaneous Vagus Nerve Stimulation; sham Transcutaneous Vagus Nerve Stimulation

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Suez Canal University

Ismailia, 41522, Egypt

Location

Related Publications (1)

• Elsehrawy GG, Ibrahim ME, A Moneim NH, Hefny MA, El Shaarawy NK. Transcutaneous vagus nerve stimulation as a pain modulator in knee osteoarthritis: a randomized controlled clinical trial. BMC Musculoskelet Disord. 2025 Jan 20;26(1):68. doi: 10.1186/s12891-025-08288-6.

  PMID: 39828740 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• 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 DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: May 24, 2022
• Study Start: August 5, 2019
• Primary Completion: July 5, 2021
• Study Completion: May 5, 2022
• Last Updated: May 24, 2022

Record last verified: 2022-05

Locations

EG (1)