Clinical trial NCT04381624: Transcutaneous Vagal Stimulation in Knee Osteoarthritis
Official title: Transcutaneous Vagal Stimulation in Knee Osteoarthritis (TRAVKO): Protocol of a Superiority, Outcome Assessor- and Participant-blind, Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: pain
pain management
transcutaneous vagal stimulation
exercise
Lead sponsor: Universidad de La Frontera
Sponsor class: OTHER
First posted: 2020-05-11
Enrollment: 70
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomised controlled, two-arm, double-blind
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Women and men aged 55 and over;
2. Medical diagnosis of osteoarthritis of the knee according to the criteria of the American College of Rheumatologists;
3. Chronic pain (i.e., 3 months or more)
4. Average pain of the last seven days among 30 mm and 80 mm on the Visual Analogue Scale;
5. Walking without technical aids or knee brace;
6. Availability to attend an exercise program three times a week for four weeks;
7. Access to communication via telephone;
8. Agree to participate in the study by signing an informed consent form.

Exclusion Criteria:

1. Presence of the following symptoms and signs: Fever or chills, large effusions, paresthesias or paresis of the lower limb;
2. Presence of medically diagnosed psychiatric or neurological diseases (cognitive impairment, Alzheimer's, Parkinson's, epilepsy, moderate or severe depression, bipolar disorders, obsessive-compulsive disorder, etc.)
3. Neuromuscular or cardiac disorders (i.e., arrhythmia, conduction cardiac block), stroke, generalised rheumatology, dia-betes mellitus II, morbid obesity (i.e., equal to or greater than III);
4. Medical contraindication of physical exercise;
5. Joint infiltration or lower limb surgery in the previous 6 months;
6. Surgery is planned for the next 6 months;
7. Take strong regular two or more kinds of medication;
8. Conditions that affect the lower limb and/or limit its functional capacity, such as previous fractures in the area, deformity, joint replacement, tibial osteotomy;
9. Participation in exercise programs in the last nine months;
10. Inability to follow instructions.

Primary outcomes:
measure: average of the last seven days (VAS-7D)
timeFrame: at the end of treatment (1 month), 1 month, and 3 months of follow-up
Secondary outcomes:
measure: intensity of the pain at rest (VAS-R) and walking on flat ground (VAS-W)
timeFrame: Baseline, at the end of treatment (1 month), 1 month, and 3 months of follow-up
measure: Functional capacity
timeFrame: Baseline, at the end of treatment (1 month), 1 month, and 3 months of follow-up
measure: Pain-related interference
timeFrame: Baseline, at the end of treatment (1 month), 1 month, and 3 months of follow-up
measure: Pain-related distress
timeFrame: Baseline, at the end of treatment (1 month), 1 month, and 3 months of follow-up
measure: Quality of life in older adults
timeFrame: Baseline, at the end of treatment (1 month), 1 month, and 3 months of follow-up
measure: Global change
timeFrame: at the end of treatment (1 month), 1 month, and 3 months of follow-up
measure: Session attendance
timeFrame: at the end of treatment (1 month)
measure: Adverse Events
timeFrame: at the end of treatment (1 month)
measure: Gait speed test
timeFrame: Baseline, at the end of treatment (1 month)
measure: Standing and sitting in 30 seconds
timeFrame: Baseline, at the end of treatment (1 month)
measure: Time up and go
timeFrame: Baseline, at the end of treatment (1 month)
measure: Unipodal stance task
timeFrame: Baseline, at the end of treatment (1 month)
Other outcomes:
measure: Kinesiophobia
timeFrame: Baseline, at the end of treatment (1 month)
measure: Sleep Quality
timeFrame: Baseline, at the end of treatment (1 month)
measure: Pain Catastrophism
timeFrame: Baseline, at the end of treatment (1 month)
measure: Negative Affectivity
timeFrame: Baseline, at the end of treatment (1 month)
measure: Pain Self-Efficacy
timeFrame: Baseline, at the end of treatment (1 month)
Locations:
city: Temuco
country: Chile
facility: Universidad de La Frontera
state: La Araucania
Study officials:
affiliation: Universidad de La Frontera
name: Claudio Bascour, PhD
role: PRINCIPAL_INVESTIGATOR
References: