Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-28 @ 4:47 AM
Study NCT ID:
NCT05387135
Status:
COMPLETED
Last Update Posted:
2022-05-24
First Post:
2022-05-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transcutaneous Vagus Nerve Stimulation As a Pain Modulator in Knee Osteoarthritis
Sponsor:
Suez Canal University
Organization:
Study Overview
Official Title:
Transcutaneous Vagus Nerve Stimulation As a Pain Modulator in Knee Osteoarthritis
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: