Clinical trial NCT05625178: Effects of Vagus Nerve Stimulation on Central Pain Sensitivity & Parasympathetic Function in Knee Osteoarthritis
Official title: Investigating Effects of Auricular Vagus Nerve Stimulation on Central Pain Mechanisms, Autonomic Function, and Pain Severity in People With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Central Pain Syndrome
Lead sponsor: University of Texas, El Paso
Sponsor class: OTHER
First posted: 2022-11-22
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* chronic knee pain consistent with a clinical osteoarthritis diagnosis, which does not require radiographic evidence (age ≥ 45 years, activity-related knee pain, and no knee morning stiffness lasting \>30 minutes)
* knee pain ≥ 3 months
* average pain intensity ≥ 4 on a scale from 0 to 10
* knee pain as the chief complaint
* able to understand English

Exclusion Criteria:

* current skin disease of the left ear interfering with the application of the auricular electrode for stimulation(eczema, urticarial lesion, skin infection, external otitis, etc.)
* auditory canal not adapted to the application of the ear electrode
* known history of cardiac rhythm disturbances or atrioventricular block \> 1st degree, conduction disturbances
* recurrent vagal syncope
* history of vagotomy
* use of other medical devices electrically active (pacemaker, transcutaneous electrical nerve stimulation, etc)
* serious and uncontrolled concomitant disease, including cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine, gastrointestinal, epileptic disease or malignant diseases
* pregnant or breastfeeding woman
* numbness or sensation loss on the body sites for pain measurements (i.e., the wrist, knee, the forearm)
* any intervention procedures for knee pain in the past 3 months
* age less than 45 years old

Primary outcomes:
measure: Change in Pressure Pain Threshold
timeFrame: Same day assessment with 3 data points: baseline, immediately after- and 15 minutes after tVNS intervention
measure: Change in Conditioned Pain Modulation
timeFrame: Same day assessment with 3 data points: baseline, immediately after- and 15 minutes after tVNS intervention
measure: Change in Temporal Summation
timeFrame: Same day assessment with 3 data points: baseline, immediately after- and 15 minutes after tVNS intervention
measure: Change in Parasympathetic Function
timeFrame: Same day assessment with 3 data points: baseline, immediately after- and 15 minutes after tVNS intervention
measure: Change in knee pain
timeFrame: Same day assessment with 3 data points: baseline, immediately after- and 15 minutes after tVNS intervention
measure: Change in and The Western Ontario McMaster Universities Osteoarthritis Index
timeFrame: Same day assessment with 3 data points: baseline, immediately after- and 15 minutes after tVNS intervention
measure: Safety about tVNS intervention
timeFrame: At the end of the study visit
measure: Satisfaction Level
timeFrame: At the end of the study visit
Secondary outcomes:
measure: Pain catastrophizing scale (PCS)
timeFrame: Immediately before tVNS intervention
measure: Fear avoidance belief questionnaire (FABQ)
timeFrame: Immediately before tVNS intervention
measure: Pittsburgh sleep quality index (PSQI)
timeFrame: Immediately before tVNS intervention
measure: Hospital anxiety and depression scale (HADS)
timeFrame: Immediately before tVNS intervention
measure: Ethnic Identity (Multigroup Ethnic Identity Measure (MEIM)
timeFrame: Immediately before tVNS intervention
Other outcomes:
Locations:
city: El Paso
country: United States
facility: University of Texas at El Paso
state: Texas
Study officials:
References: