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Vagus Nerve Stimulation for Knee Osteoarthritis
Study Summary
This trial aims to test the effect of tVNS on knee OA pain and autonomic function, measuring pain severity, central pain sensitivity, and heart rate variability.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- My main health issue is knee pain.I have not had any treatments for knee pain in the last 3 months.I am under 45 years old.I have had knee pain for at least 3 months.I have had surgery to remove part of my vagus nerve.I experience numbness or loss of sensation in my wrist, knee, or forearm.I have had more than one fainting episode due to vagal syncope.I have a history of heart rhythm problems or electrical signal issues in my heart.I do not have any serious uncontrolled diseases besides my current condition.I am over 45 and have knee pain from osteoarthritis without needing an X-ray to prove it.My average pain level is 4 or higher on a scale of 0 to 10.I do not have skin issues on my left ear that would prevent electrode use.
- Group 1: tVNS group
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does this clinical study include elderly participants aged 70 and over?
"Patients aged between 45 and 90 are eligible to apply for this trial. Additionally, there are 37 medical studies available specifically for minors and a further 670 clinical trials accessible by individuals over the age of 65."
Are enrollees being accepted at this point in the clinical trial?
"Based on the information posted to clinicaltrials.gov, this trial is still recruiting patients at the time of writing. It was first listed on December 15th 2022 and its details were last modified on May 9th 2023."
Am I eligible to partake in this clinical experiment?
"For this clinical trial, 30 individuals aged 45 to 90 with osteoarthritis are being sought. All applicants must demonstrate chronic knee pain consistent with such a diagnosis (no imaging required), at least 3 months of discomfort that rates 4/10 or higher on the pain scale, and have no morning stiffness for over half an hour. Moreover, all participants need to understand English as it is the official language of communication."
Are there limits to the number of participants accepted into this medical experiment?
"Affirmative. Clinicaltrials.gov data demonstrate that this medical research study, which was initially posted on December 15th 2022 and most recently modified on May 9th 2023, is currently enrolling 30 patients from a single site."
What core aims is this medical trial hoping to achieve?
"The primary goal of this clinical trial, assessed over the course of one day via three data points (baseline, immediate post-intervention, and 15 minutes after tVNS intervention) is to measure Patient Satisfaction. Secondary objectives include quantifying Ethnic Identity using a 12 item survey with 1-4 point scale (1 meaning poor identity, 4 strong), Fear Avoidance Beliefs measured by 16 questions graded from 0 to 6 (where higher numbers equate to heightened fear responses), and Sleep Quality analyzed through a 19 question questionnaire producing an overall score ranging between 0 and 21 (0-4 indicating absence of sleep issues)."
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