Transcutaneous Vagal Stimulation in Knee Osteoarthritis

NCT ID: NCT04381624

Last Updated: 2022-12-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-03-01

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.

Conditions

Osteoarthritis, Knee

Keywords

pain; pain management; transcutaneous vagal stimulation; exercise

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Transcutaneous Vagal Stimulation

TVS will be applied through a portable electrostimulation equipment during the whole session in each of the treatment sessions. The electrodes will be placed in the left ear, specifically in the auricular concha. The device will be programmed with a biphasic square current at an intensity that produces a clear tingling sensation that is neither uncomfortable nor painful, with pulses of 300 microseconds, at 25 Hertz, the stimulus will be present for 30 seconds and will be followed by a 30-second rest period repeating this for approximately one hour.

Group Type: EXPERIMENTAL

Exercise program

Intervention Type: OTHER

exercise program in 12 sessions, of approximately one hour, distributed in 3 sessions per week during a month

Sham Transcutaneous Vagal Stimulation

The device will be configured with the same parameters and intensity of the real TVS. However the device will be located in the left ear lobe.

Group Type: PLACEBO_COMPARATOR

Exercise program

Intervention Type: OTHER

exercise program in 12 sessions, of approximately one hour, distributed in 3 sessions per week during a month

Interventions

Exercise program

exercise program in 12 sessions, of approximately one hour, distributed in 3 sessions per week during a month

Intervention Type: OTHER

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.

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad de La Frontera

OTHER

Sponsor Role: lead

Responsible Party

Germán Gálvez García

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claudio Bascour, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad de La Frontera

Locations

Universidad de La Frontera

Temuco, La Araucania, Chile

Countries

Chile

Central Contacts

Claudio Bascour, PhD

Role: CONTACT

Phone: +56973871095

Email: claudio.bascour@ufrontera.cl

Claudio Muñoz, PhD

Role: CONTACT

Phone: +56452325795

Email: claudio.munoz@ufrontera.cl

Facility Contacts

Claudio Bascour, PhD

Role: primary

Claudio Muñoz, PhD

Role: backup

Other Identifiers

FONIS SA19/0003

Identifier Type: -

Identifier Source: org_study_id