Transcutaneous Vagus Nerve Stimulation As a Pain Modulator in Knee

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05387135
Study type	Interventional
Source	Suez Canal University
Contact
Status	Completed
Phase	N/A
Start date	August 5, 2019
Completion date	May 5, 2022

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Transcutaneous Vagus Nerve Stimulation As a Pain Modulator in Knee Osteoarthritis

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms