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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
Knee pain as the chief complaint
Average pain intensity ≥ 4 on a scale from 0 to 10
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately before tvns intervention
Awards & highlights

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.

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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My main health issue is knee pain.
Select...
My average pain level is 4 or higher on a scale of 0 to 10.
Select...
I have had knee pain for at least 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately before tvns intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately before tvns intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Conditioned Pain Modulation
Change in Parasympathetic Function
Change in Pressure Pain Threshold
+5 more
Secondary outcome measures
Ethnic Identity (Multigroup Ethnic Identity Measure (MEIM)
Fear avoidance belief questionnaire (FABQ)
Hospital anxiety and depression scale (HADS)
+2 more

Trial 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
13 Previous Clinical Trials
2,663 Total Patients Enrolled
1 Trials studying Osteoarthritis
60 Patients Enrolled for Osteoarthritis

Media Library

Transcutaneous vagus nerve stimulation (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05625178 — N/A
Osteoarthritis Research Study Groups: tVNS group
Osteoarthritis Clinical Trial 2023: Transcutaneous vagus nerve stimulation Highlights & Side Effects. Trial Name: NCT05625178 — N/A
Transcutaneous vagus nerve stimulation (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05625178 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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)."

Answered by AI
~10 spots leftby Dec 2024