NCT04381624

Transcutaneous Vagal Stimulation in Knee Osteoarthritis

Transcutaneous Vagal Stimulation in Knee Osteoarthritis (TRAVKO): Protocol of a Superiority, Outcome Assessor- and Participant-blind, Randomised Controlled Trial.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Universidad de La Frontera · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy of Transcutaneous Vagal Stimulation in people whit knee osteoarthritis.

Detailed description

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.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
OTHER	Exercise program	exercise program in 12 sessions, of approximately one hour, distributed in 3 sessions per week during a month

Timeline

• Start date: 2023-03-01
• Primary completion: 2023-12-25
• Completion: 2024-03-01
• First posted: 2020-05-11
• Last updated: 2022-12-13

Locations

1 site across 1 country: Chile