All > Knee Osteoarthritis

tVNS group for Osteoarthritis

University of Texas at El Paso, El Paso, TX
Osteoarthritis+1 More ConditionsTranscutaneous vagus nerve stimulation - Device
Eligibility
45 - 90
All Sexes

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.

Eligible Conditions
  • Osteoarthritis of the Knee
  • Central Pain Syndrome

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

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Study Objectives

8 Primary · 5 Secondary · Reporting Duration: Immediately before tVNS intervention

At the end of the study visit
Safety about tVNS intervention
Satisfaction Level
Immediately before tVNS intervention
Ethnic Identity (Multigroup Ethnic Identity Measure (MEIM)
Fear avoidance belief questionnaire (FABQ)
Hospital anxiety and depression scale (HADS)
Pain catastrophizing scale (PCS)
Pittsburgh sleep quality index (PSQI)
Same day assessment with 3 data points: baseline, immediately after- and 15 minutes after tVNS intervention
Change in Conditioned Pain Modulation
Change in Parasympathetic Function
Change in Pressure Pain Threshold
Change in Temporal Summation
Change in and The Western Ontario McMaster Universities Osteoarthritis Index
Change in knee pain

Trial Safety

Phase-Based Safety

1 of 3

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1
Geniculate Artery Embolization arm
2
QUC398
2
F508del Homozygous or Heterozygous CF Participants

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

tVNS group
1 of 1

Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: tVNS group · No Placebo Group · N/A

tVNS group
Device
Experimental Group · 1 Intervention: Transcutaneous vagus nerve stimulation · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: immediately before tvns intervention

Who is running the clinical trial?

University of Texas, El PasoLead Sponsor
11 Previous Clinical Trials
2,503 Total Patients Enrolled

Eligibility Criteria

Age 45 - 90 · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have long-term knee pain that is consistent with osteoarthritis, and you don't need an X-ray to confirm it. You must be at least 45 years old, have knee pain related to activity, and no morning stiffness in the knee that lasts for more than 30 minutes.
You feel pain that rates at least 4 out of 10 on a pain scale.
You are experiencing pain in your knee as the main issue.
You can speak and understand English.
You have been experiencing knee pain for at least three months.
References

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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](https://www.withpower.com/clinical-trials/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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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)." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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