Vagus Nerve Stimulation for Knee Osteoarthritis
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Texas, El Paso
Disqualifiers: Cardiac rhythm disturbances, Vagal syncope, Pacemaker, Serious diseases, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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).
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Transcutaneous vagus nerve stimulation (tVNS) for knee osteoarthritis?
Research on similar conditions, like erosive hand osteoarthritis, shows that transcutaneous vagus nerve stimulation (tVNS) can reduce pain and inflammation. A pilot study found that tVNS significantly decreased hand pain and improved function, suggesting it might also help with knee osteoarthritis.
12345Is vagus nerve stimulation safe for humans?
Transcutaneous auricular vagus nerve stimulation (taVNS) is generally considered safe, with mild and temporary side effects like ear pain, headache, and tingling. Studies show no significant risk of severe adverse events compared to controls.
678910How does transcutaneous vagus nerve stimulation (tVNS) differ from other treatments for knee osteoarthritis?
Transcutaneous vagus nerve stimulation (tVNS) is unique because it involves non-invasive electronic stimulation of the ear's auricular concha to potentially reduce pain, unlike other treatments that may involve medication or surgery. This method is being tested for its effectiveness in knee osteoarthritis, offering a novel approach that could complement existing therapies.
1112131415Eligibility Criteria
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.Inclusion Criteria
My main health issue is knee pain.
Able to understand English
I have had knee pain for at least 3 months.
+2 more
Exclusion Criteria
Use of other medical devices electrically active (pacemaker, transcutaneous electrical nerve stimulation, etc.)
I have not had any treatments for knee pain in the last 3 months.
Pregnant or breastfeeding woman
+8 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Baseline Assessment
Participants complete self-reported questionnaires and baseline assessments of knee pain severity, central pain sensitivity, and heart rate variability.
1 day
1 visit (in-person)
tVNS Intervention
Participants receive a 60-minute transcutaneous vagus nerve stimulation (tVNS) session at the cymba concha of the left ear.
1 day
1 visit (in-person)
Post-Intervention Assessment
Investigators assess changes in knee pain, central pain sensitivity, and autonomic function immediately after and 15 minutes after tVNS intervention.
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including satisfaction level and safety assessment.
1-2 weeks
Participant Groups
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.
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Texas at El PasoEl Paso, TX
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Who Is Running the Clinical Trial?
University of Texas, El PasoLead Sponsor
References
Transcutaneous vagus nerve stimulation in erosive hand osteoarthritis: protocol for the randomised, double-blind, sham-controlled ESTIVAL trial. [2022]Patients with erosive hand osteoarthritis (EHOA) experience pain and inflammation, two features that can be targeted by vagus nerve stimulation using electrical auricular transcutaneous vagus nerve stimulation (tVNS). A pilot study demonstrated the feasibility of the procedure, so we designed a randomised sham-controlled trial to determine the safety and efficacy of tVNS in EHOA.
Effect of Transcutaneous Vagus Nerve Stimulation in Erosive Hand Osteoarthritis: Results from a Pilot Trial. [2022]Beyond its effect on vegetative functions, the activation of the vagus nerve inhibits inflammation and reduces pain signaling. The aim of this open-label pilot study was to determine the efficacy and tolerance of transcutaneous auricular VNS (taVNS) on erosive hand osteoarthritis (EHOA) symptoms. Symptomatic EHOA patients with hand pain VAS ≥ 40/100 mm and ≥1 interphalangeal swollen joint(s) were included. The taVNS was performed for 4 weeks using an auricular electrode applied one hour per day and connected to a TENS device with pre-established settings. Clinical efficacy was evaluated by changes between baseline and at 4 weeks with hand pain VAS and the functional index FIHOA score, using a Wilcoxon t-test. The treatment tolerance was also evaluated. Eighteen patients (median age 69 years old, 83% women) were analyzed. At baseline, hand pain VAS was 60 mm [IQR 50; 78.2] and FIHOA 15 [10.7; 20.2]. After 4 weeks, taVNS significantly reduced hand pain VAS, with a median decrease of 23.5 mm [7.7; 37.2] (p = 0.001), as well as FIHOA, with a median decrease of 2 points [0.75; 5.2] (p = 0.01). No serious adverse events were reported. One patient stopped taVNS because of auricular discomfort. This first proof-of-concept trial indicated that taVNS is feasible and may decrease joint inflammation and clinical symptoms in EHOA, arguing for a randomized controlled study versus sham stimulation.
Noninvasive Vagus Nerve Stimulation in Postural Tachycardia Syndrome: A Randomized Clinical Trial. [2023]Low-level transcutaneous stimulation of the auricular branch of the vagus nerve at the tragus is antiarrhythmic and anti-inflammatory in animals and humans. Preliminary studies show that transcutaneous vagus nerve stimulation (tVNS) is beneficial in animal models of postural tachycardia syndrome (POTS).
Effect of transcutaneous auricular vagus nerve stimulation on delayed neurocognitive recovery in elderly patients. [2022]The aim of this study was to investigate whether transauricular vagus nerve stimulation (taVNS) could decrease the incidence of delayed neurocognitive recovery (dNCR) in elderly adults after total joint arthroplasty (TJA).
Transcutaneous Vagus Nerve Stimulation in Patients With Severe Traumatic Brain Injury: A Feasibility Trial. [2022]Preclinical studies have shown that surgically implanted vagus nerve stimulation (VNS) promotes recovery of consciousness and cognitive function following experimental traumatic brain injury (TBI). The aim of this study is to report the feasibility and safety of a noninvasive transcutaneous vagus nerve stimulation (tVNS) in patients with persistent impairment of consciousness following severe TBI.
Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis. [2023]Transcutaneous auricular vagus nerve stimulation (taVNS) has been investigated as a novel neuromodulation tool. Although taVNS is generally considered safe with only mild and transient adverse effects (AEs), those specifically caused by taVNS have not yet been investigated. This systematic review and meta-analysis on taVNS aimed to (1) systematically analyze study characteristics and AE assessment, (2) characterize and analyze possible AEs and their incidence, (3) search for predictable risk factors, (4) analyze the severity of AE, and (5) suggest an evidence-based taVNS adverse events questionnaire for safety monitoring. The articles searched were published through April 7, 2022, in Medline, Embase, Web of Science, Cochrane, and Lilacs databases. In general, we evaluated 177 studies that assessed 6322 subjects. From these, 55.37% of studies did not mention the presence or absence of any AEs; only 24.86% of the studies described that at least one adverse event occurred. In the 35 studies reporting the number of subjects with at least one adverse event, a meta-analytic approach to calculate the risk differences of developing an adverse event between active taVNS and controls was used. The meta-analytic overall adverse events incidence rate was calculated for the total number of adverse events reported on a 100,000 person-minutes-days scale. There were no differences in risk of developing an adverse event between active taVNS and controls. The incidence of AE, in general, was 12.84/100,000 person-minutes-days of stimulation, and the most frequently reported were ear pain, headache, and tingling. Almost half of the studies did not report the presence or absence of any AEs. We attribute this to the absence of AE in those studies. There was no causal relationship between taVNS and severe adverse events. This is the first systematic review and meta-analysis of transcutaneous auricular stimulation safety. Overall, taVNS is a safe and feasible option for clinical intervention.
Non-invasive vagus nerve stimulation acutely improves spontaneous cardiac baroreflex sensitivity in healthy young men: A randomized placebo-controlled trial. [2018]Despite positive outcomes of transcutaneous vagus nerve stimulation (tVNS) via the auricular branch of the vagus nerve (ABVN), the mechanisms underlying these outcomes remain unclear. Additionally, previous studies have not been controlled the possible placebo effects of tVNS.
Transcutaneous Auricular Vagus Nerve Stimulation Normalizes Induced Gastric Myoelectrical Dysrhythmias in Controls Assessed by Body-Surface Gastric Mapping. [2023]Transcutaneous auricular vagus nerve stimulation (TaVNS) is a supplementary treatment for gastric symptoms resulting from dysrhythmias. The main objective of this study was to quantify the effects of 10, 40, and 80 Hz TaVNS and sham in healthy individuals in response to a 5-minute water-load (WL5) test.
The efficacy and safety of transcutaneous auricular vagus nerve stimulation in the treatment of depressive disorder: A systematic review and meta-analysis of randomized controlled trials. [2023]Transcutaneous auricular vagus nerve stimulation (taVNS) is used for treating depression but the efficacy and safety have not been well assessed. This study was conducted to evaluate the efficacy and safety of taVNS in depression.
Laboratory Administration of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS): Technique, Targeting, and Considerations. [2020]Non-invasive vagus nerve stimulation (VNS) may be administered via a novel, emerging neuromodulatory technique known as transcutaneous auricular vagus nerve stimulation (taVNS). Unlike cervically-implanted VNS, taVNS is an inexpensive and non-surgical method used to modulate the vagus system. taVNS is appealing as it allows for rapid translation of basic VNS research and serves as a safe, inexpensive, and portable neurostimulation system for the future treatment of central and peripheral disease. The background and rationale for taVNS is described, along with electrical and parametric considerations, proper ear targeting and attachment of stimulation electrodes, individual dosing via determination of perception threshold (PT), and safe administration of taVNS.
Transcutaneous Vagal Stimulation in Knee Osteoarthritis (TRAVKO): Protocol of a Superiority, Outcome Assessor- and Participant-Blind, Randomised Controlled Trial. [2023]Current treatments for knee osteoarthritis (KOA) are partially effective. It is, therefore, necessary to find new strategies that can complement the existing ones. In this scenario, transcutaneous vagal stimulation (TVS) neurophysiological effects could be a helpful solution. However, there is no evidence of the efficacy of TVS in KOA. This trial aims to assess the efficacy of TVS in decreasing pain in participants aged 55 years or older with KOA. A randomised controlled, two-arm, double-blind (participants and outcome assessors) and clinical superiority trial will be conducted for 70 patients with KOA. All the participants will carry out an exercise program. It consists of 12 sessions over four weeks. In addition, they will be randomly assigned to (1) active TVS plus physical exercise or (2) sham TVS plus physical exercise. The application of active TVS consists of electronic stimulation of the auricular concha using a portable device. Sham TVS condition consists of the stimulation of the earlobe that does not cause neurophysiological effects. The primary outcome is the reduction in pain intensity. Additionally, functional capacity, physical performance, pain-related interference, pain-related distress, quality of life in older adults and global change will be measured. Assessments will be conducted at the beginning of the study (baseline), at the end of the intervention and after 1 and 3 months of follow-up. This trial will generate evidence regarding the efficacy of TVS in pain perception in individuals with KOA. This information will serve as an input in the clinical decision-making on the use or non-use of TVS in individuals with KOA. Thus, if the efficacy of TVS is confirmed, a new therapeutic tool may be included in the rehabilitation of individuals with KOA.
Optimal stimulation frequency of transcutaneous electrical nerve stimulation on people with knee osteoarthritis. [2022]This is a double blind study that examined the optimal stimulation frequency of transcutaneous electrical nerve stimulation in reducing pain due to knee osteoarthritis.
Transcutaneous Electrical Nerve Stimulation in Patients With Knee Osteoarthritis: Evidence From Randomized-controlled Trials. [2019]Transcutaneous electrical nerve stimulation (TENS) has been reported to relieve pain and improve function in patients with knee osteoarthritis. The purpose of this systematic review and meta-analysis was to evaluate the efficacy of TENS for the management of knee osteoarthritis.
Knee Osteoarthritis: Does Transcutaneous Electrical Nerve Stimulation Work? [2018]Transcutaneous electrical nerve stimulation has been proposed as a nonoperative treatment for osteoarthritis. The purpose of this study was to evaluate the outcomes of a novel transcutaneous electrical nerve stimulation device compared with those of other standard nonoperative modalities for the treatment of osteoarthritis of the knee.
A Case Report of Three Patients Who Underwent Temporary Peripheral Nerve Stimulation for Treatment of Knee Pain Secondary to Osteoarthritis. [2023]Knee osteoarthritis affects millions of people worldwide. There remains a role for novel therapies to manage pain for patients who are unable or unwilling to undergo knee arthroplasty. A peripheral nerve stimulator (PNS) may be beneficial in this population. We present a case report of three patients who received temporary femoral or saphenous PNS and were either unwilling or unable to undergo knee arthroplasty. Two of the three patients reported significantly reduced pain and improved functioning. Our case report demonstrates that temporary PNS may offer a safe and effective treatment for chronic knee pain secondary to knee osteoarthritis.