Transcutaneous Vagus Nerve Stimulation As a Pain Modulator in Knee Osteoarthritis

NCT ID: NCT05387135

Last Updated: 2022-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-05
• Study Completion Date: 2022-05-05

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.

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

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: SHAM_COMPARATOR

Transcutaneous Vagus Nerve Stimulation

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Transcutaneous Vagus Nerve Stimulation

Intervention Type: 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).

Interventions

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).

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suez Canal University

OTHER

Sponsor Role: lead

Responsible Party

Gehad Gamal Elsehrawy

Assistant Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohammed A Hefny, MD

Role: STUDY_DIRECTOR

professor of physical medicine, rheumatology and rehabilitation

Nashwa K Elshaarawy, MD

Role: STUDY_DIRECTOR

Assisstant professor of physical medicine, rheumatology and rehabilitation

Nermeen H Abdelmoneam, Ph.D

Role: STUDY_DIRECTOR

lecturer of physical medicine, rheumatology and rehabilitation

Locations

Suez Canal University

Ismailia, , Egypt

Countries

Egypt

References

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.

Reference Type: DERIVED

PMID: 39828740 (View on PubMed)

Other Identifiers

3905

Identifier Type: -

Identifier Source: org_study_id