Transcutaneous Vagal Stimulation in Knee Osteoarthritis

NCT04381624 | Unknown

• 1 other identifier: FONIS SA19/0003
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteoarthritis, Knee

Keywords

pain; pain management; transcutaneous vagal stimulation; exercise

Outcome Measures

Primary Outcomes (1)

• average of the last seven days (VAS-7D)

  It will be evaluated through the Visual Analog Scale (VAS). This consists of a 100 mm horizontal line. On the left extreme it says "no pain" and on the right extreme decree it says "worst pain imaginable". The individual must indicate the intensity of pain by means of a mark. The result will be expressed by millimetres.

  at the end of treatment (1 month), 1 month, and 3 months of follow-up

Secondary Outcomes (12)

• intensity of the pain at rest (VAS-R) and walking on flat ground (VAS-W)

  Baseline, at the end of treatment (1 month), 1 month, and 3 months of follow-up

• Functional capacity

  Baseline, at the end of treatment (1 month), 1 month, and 3 months of follow-up

• Pain-related interference

  Baseline, at the end of treatment (1 month), 1 month, and 3 months of follow-up

• Pain-related distress

  Baseline, at the end of treatment (1 month), 1 month, and 3 months of follow-up

• Quality of life in older adults

  Baseline, at the end of treatment (1 month), 1 month, and 3 months of follow-up

Other Outcomes (5)

• Kinesiophobia

  Baseline, at the end of treatment (1 month)

• Sleep Quality

  Baseline, at the end of treatment (1 month)

• Pain Catastrophism

  Baseline, at the end of treatment (1 month)

Study Arms (2)

Transcutaneous Vagal Stimulation

EXPERIMENTAL

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.

Other: Exercise program

Sham Transcutaneous Vagal Stimulation

PLACEBO COMPARATOR

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.

Other: Exercise program

Interventions

Exercise program OTHER

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

Sham Transcutaneous Vagal Stimulation; Transcutaneous Vagal Stimulation

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Presence of the following symptoms and signs: Fever or chills, large effusions, paresthesias or paresis of the lower limb;
• 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.)
• 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);
• Medical contraindication of physical exercise;
• Joint infiltration or lower limb surgery in the previous 6 months;
• Surgery is planned for the next 6 months;
• Take strong regular two or more kinds of medication;
• Conditions that affect the lower limb and/or limit its functional capacity, such as previous fractures in the area, deformity, joint replacement, tibial osteotomy;
• Participation in exercise programs in the last nine months;
• Inability to follow instructions.

Sponsors & Collaborators

• Universidad de La Frontera: lead

Study Sites (1)

Universidad de La Frontera

Temuco, La Araucania, 4781176, Chile

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain; Agnosia; Motor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Claudio Bascour, PhD

  Universidad de La Frontera

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudio Bascour, PhD

CONTACT

+56973871095; claudio.bascour@ufrontera.cl

Claudio Muñoz, PhD

CONTACT

+56452325795; claudio.munoz@ufrontera.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: randomised controlled, two-arm, double-blind

Study Record Dates

• First Submitted: April 18, 2020
• First Posted: May 11, 2020
• Study Start: March 1, 2023
• Primary Completion: December 25, 2023
• Study Completion: March 1, 2024
• Last Updated: December 13, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 3 months following main results article publication
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. For individual participant data meta-analysis. Proposals should be directed to Principal Investigator. To gain access, data requestors will need to sign a data access agreement

Locations

CL (1)