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NCT05625178 · ClinicalTrials.gov registry record · NA

Effects of Vagus Nerve Stimulation on Central Pain Sensitivity & Parasympathetic Function in Knee Osteoarthritis

A NA study of Knee Osteoarthritis and Central Pain Syndrome, sponsored by University of Texas, El Paso.

Completed
Registry status
NA
Development phase
30
Enrollment target
1
Study location

NCT05625178: Completed NA study of Knee Osteoarthritis and Central Pain Syndrome, sponsored by University of Texas, El Paso.

NCT05625178 is a NA study of Knee Osteoarthritis and Central Pain Syndrome that has completed, run by University of Texas, El Paso. The registered enrollment target is 30 participants, below the 304-participant average among 101 other Knee Osteoarthritis trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05625178, a NA study of Knee Osteoarthritis and Central Pain Syndrome, has completed, sponsored by University of Texas, El Paso.

COMPLETED
Registry status
NA
Development phase
30 participants
Enrollment target
1
Study location

Study Summary

The goal of this clinical trial is to test the feasibility and effectiveness of transcutaneous vagus nerve stimulation (tVNS) to the ear on pain and autonomic function in people with knee osteoarthritis (OA). The main questions it aims to answer are: 1) whether tVNS is feasible to be used in people with knee OA; 2) whether tVNS demonstrates the trend in improving knee pain; and 3) whether tVNS has physiological effects on autonomic function (e.g., parasympathetic function) and pain perception in the central nervous system such as brain (i.e., central pain mechanisms). Participants will be asked to complete a battery of self-reported questionnaires about their demographic and behavioral information, ethnicity, pain, sleep, psychological/emotional symptoms. Subsequently, participants will complete baseline assessment where investigators will assess their knee pain severity, central pain sensitivity, and heart rate variability (a measurement for autonomic function). Then participants will receive a 60-minute tVNS. Investigators will redo the same assessment as baseline assessment after tVNS intervention to see the degree of knee pain, central pain sensitivity, and autonomic function changes. At the end of the study, investigators will assess their satisfaction level with the tVNS intervention and the feasibility of the intervention (e.g., completion rate, side effects).

Primary Outcome

Pressure pain thresholds (PPT) will be assessed at the wrist and patellae. PPT being assessed at a remote body site (e.g., wrist) is to measure central pain sensitivity while PPT being assessed at the location of pain (i.e., knee, patellae) is to assess peripheral pain sensitivity with or without central pain sensitivity. PPT will be assessed using a handheld pressure algometer with 1 cm2 rubber tip. PPT will be defined as the point at which the participant verbally indicated that the pressure f

Interventions

  • DEVICE Transcutaneous vagus nerve stimulation

Study Locations (1)

Texas

  • University of Texas at El Paso - El Paso

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2022-12-15
Est. Completion 2023-06-08
Phase NA
University of Texas, El Paso

17 total trials

What the finished NCT05625178 record still lists

NCT05625178 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 304-participant average among 101 other Knee Osteoarthritis trials with a reported enrollment target (90% lower).

The record links to 2 conditions, with Knee Osteoarthritis appearing as the primary indexed condition, and to 1 intervention - of which Transcutaneous vagus nerve stimulation is the first listed.

NCT05625178 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT05625178 about?

NCT05625178 is a clinical study titled "Effects of Vagus Nerve Stimulation on Central Pain Sensitivity & Parasympathetic Function in Knee Osteoarthritis". The goal of this clinical trial is to test the feasibility and effectiveness of transcutaneous vagus nerve stimulation (tVNS) to the ear on pain and autonomic function in people with knee osteoarthritis (OA). The main questions it aims to answer are: 1) whether tVNS is feasible to be used in people ...

What is the current status of trial NCT05625178?

This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2022-12-15. Estimated completion is 2023-06-08.

What conditions does trial NCT05625178 study?

This clinical trial studies the following conditions: Knee Osteoarthritis, Central Pain Syndrome.

What interventions are being tested in trial NCT05625178?

The interventions under investigation include: Transcutaneous vagus nerve stimulation (DEVICE).

Who is sponsoring clinical trial NCT05625178?

This trial is sponsored by University of Texas, El Paso, which has 17 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05625178 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Knee Osteoarthritis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05625178's enrollment target sits among peer trials

30 80th of 101 higher than 15 of 101 other Knee Osteoarthritis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Knee Osteoarthritis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05625178, the US trial registry maintained by the National Library of Medicine. NCT05625178 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.