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Behavioural Intervention
Vagus Nerve Stimulation for Knee Osteoarthritis
N/A
Recruiting
Research Sponsored by University of Texas, El Paso
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately before tvns intervention
Awards & highlights
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.
Who is the study for?
This trial is for adults over 45 with chronic knee pain from osteoarthritis, experiencing an average pain intensity of 4 or higher on a scale of 0 to 10. Participants should have had this pain for at least three months and be able to communicate in English.
What is being tested?
The study tests if ear-based vagus nerve stimulation (tVNS) can reduce knee pain and affect the body's autonomic functions like heart rate variability in people with knee osteoarthritis. It checks tVNS's feasibility, its impact on central nervous system pain mechanisms, and overall satisfaction with the treatment.
What are the potential side effects?
While not explicitly mentioned, potential side effects may include discomfort at the stimulation site, headache, dizziness or changes in heart rate due to the influence of tVNS on autonomic function.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ same day assessment with 3 data points: baseline, immediately after- and 15 minutes after tvns intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~same day assessment with 3 data points: baseline, immediately after- and 15 minutes after tvns intervention
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Conditioned Pain Modulation
Change in Parasympathetic Function
Change in Pressure Pain Threshold
+5 moreSecondary study objectives
Ethnic Identity (Multigroup Ethnic Identity Measure (MEIM)
Fear avoidance belief questionnaire (FABQ)
Hospital anxiety and depression scale (HADS)
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: tVNS groupExperimental Treatment1 Intervention
This will be a single-arm study where all study participants will receive transcutaneous vagus nerve stimulation (tVNS) at the cymba concha of the left ear for 60 minutes. The tVNS parameters will be a below-discomfort-threshold intensity with 25 Hz and a pulse width of 250 uS.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcutaneous vagus nerve stimulation
2020
N/A
~270
Find a Location
Who is running the clinical trial?
University of Texas, El PasoLead Sponsor
15 Previous Clinical Trials
2,929 Total Patients Enrolled
1 Trials studying Osteoarthritis
60 Patients Enrolled for Osteoarthritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: tVNS group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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