Osteoarthritis, KneeTRAVKONCT04381624
Transcutaneous Vagal Stimulation in Knee Osteoarthritis
A study testing Exercise program in people with Osteoarthritis, Knee, run by Universidad de La Frontera at 1 site in Chile.
Trial summary
This study will evaluate the efficacy of Transcutaneous Vagal Stimulation in people whit knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Exercise program
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteChile
- Study dates
- 1 Mar 2023to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Chile1 site
Universidad de La Frontera
Temuco, La Araucania, 4781176
Claudio Bascour, PhD, +56452325795, claudio.bascour@ufrontera.cl
Claudio Muñoz, PhD, +56452325795, claudio.munoz@ufrontera.cl
About this study
Official title: Transcutaneous Vagal Stimulation in Knee Osteoarthritis (TRAVKO): Protocol of a Superiority, Outcome Assessor- and Participant-blind, Randomised Controlled Trial.
This study will evaluate the efficacy of Transcutaneous Vagal Stimulation in people whit knee osteoarthritis.
Read the 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
- Being tested
- Exercise program
- Keywords
- pain, pain management, transcutaneous vagal stimulation, exercise
- Medical subject headings
- Osteoarthritis, Knee, Pain, Agnosia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise programOther
exercise program in 12 sessions, of approximately one hour, distributed in 3 sessions per week during a month
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: Baseline, at the end of treatment (1 month), 1 month, and 3 months of follow-up
Functional capacity
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The range of values is from 0 to 100. Lower values indicate greater functional capacity and vice versa.
Measured: Baseline, at the end of treatment (1 month), 1 month, and 3 months of follow-up
Pain-related interference
How pain interferes with the individual's daily activities is described (Treede et al., 2019). It will be assessed through an VAS that on its left end will locate the absence of interference (ie, "no interference") and on its right end will locate the maximum interference (ie, "unable to perform my activities")
Measured: Baseline, at the end of treatment (1 month), 1 month, and 3 months of follow-up
Pain-related distress
Unpleasant multifactorial emotional experience of a psychological (cognitive, behavioral and emotional), social or spiritual nature, due to persistent or recurring pain. It will be assessed by asking the participant to rate the pain-related distress they experienced in the past week on an VAS that will locate the absence of distress on its left end (ie, "no pain related distress") and on its right end will locate the maximum intensity of distress (ie, "Extreme distress related to pain")
Measured: Baseline, at the end of treatment (1 month), 1 month, and 3 months of follow-up
Quality of life in older adults
It will be measured with WHOQOL-BREF. It contains four dimensions from which scores are obtained separately. Scores range from 0 to 100. Higher scores indicate better quality of life.
Measured: Baseline, at the end of treatment (1 month), 1 month, and 3 months of follow-up
Global change
It will be evaluated with the Patient-perceived satisfactory improvement. These was constructed using a 5-point categorical rating of change scale (''worse'', ''unchanged'', ''unsatisfactory improved'', ''satisfactory improved'' and ''good to very good improved'')
Measured: at the end of treatment (1 month), 1 month, and 3 months of follow-up
Session attendance
physical therapist treatment notes
Measured: at the end of treatment (1 month)
Adverse Events
Adverse Events will be recorded, which will be understood as the perception of any problem that the participant attributes to his or her participation in the study and which requires him or her to be absent from 2 or more sessions or to seek external treatment
Measured: at the end of treatment (1 month)
Gait speed test
Meters per second
Measured: Baseline, at the end of treatment (1 month)
Standing and sitting in 30 seconds
Number of repetitions
Measured: Baseline, at the end of treatment (1 month)
Time up and go
Seconds
Measured: Baseline, at the end of treatment (1 month)
Unipodal stance task
Seconds
Measured: Baseline, at the end of treatment (1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start1 Mar 2023 (estimated)
- Primary completion25 Dec 2023 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomised controlled, two-arm, double-blind
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de La Frontera
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Germán Gálvez García, Universidad de La Frontera
- Investigators
- Claudio Bascour, PhD, Principal investigator, Universidad de La Frontera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04381624
- Sponsor's protocol ID
- FONIS SA19/0003
- Acronym
- TRAVKO
- Status last verified
- Dec 2022
- First submitted
- 18 Apr 2020
- Last updated
- 13 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the main results article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Vagal Stimulation in Knee Osteoarthritis (TRAVKO): Protocol of a Superiority, Outcome Assessor- and Participant-blind, Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT04381624
- Acronym / sponsor ID
- TRAVKO / FONIS SA19/0003
- Conditions
- Osteoarthritis, Knee
- Keywords
- pain, pain management, transcutaneous vagal stimulation, exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Universidad de La FronteraUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 25 Dec 2023 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 11 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- randomised controlled, two-arm, double-blind
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous Vagal Stimulation | Experimental | Other: Exercise programTVS 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. |
| Sham Transcutaneous Vagal Stimulation | Placebo comparator | Other: Exercise programThe 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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise programexercise program in 12 sessions, of approximately one hour, distributed in 3 sessions per week during a month | Other | Sham Transcutaneous Vagal Stimulation, Transcutaneous Vagal Stimulation |
Primary outcome
average of the last seven days (VAS-7D)
Time frame: at the end of treatment (1 month), 1 month, and 3 months of follow-up
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.
12 secondary outcomes
intensity of the pain at rest (VAS-R) and walking on flat ground (VAS-W)
Time frame: Baseline, at the end of treatment (1 month), 1 month, and 3 months of follow-up
Functional capacity
Time frame: Baseline, at the end of treatment (1 month), 1 month, and 3 months of follow-up
Pain-related interference
Time frame: Baseline, at the end of treatment (1 month), 1 month, and 3 months of follow-up
Pain-related distress
Time frame: Baseline, at the end of treatment (1 month), 1 month, and 3 months of follow-up
Quality of life in older adults
Time frame: Baseline, at the end of treatment (1 month), 1 month, and 3 months of follow-up
Global change
Time frame: at the end of treatment (1 month), 1 month, and 3 months of follow-up
Session attendance
Time frame: at the end of treatment (1 month)
Adverse Events
Time frame: at the end of treatment (1 month)
Gait speed test
Time frame: Baseline, at the end of treatment (1 month)
Standing and sitting in 30 seconds
Time frame: Baseline, at the end of treatment (1 month)
Time up and go
Time frame: Baseline, at the end of treatment (1 month)
Unipodal stance task
Time frame: Baseline, at the end of treatment (1 month)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the main results article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudio Bascour, PhD principal investigator
Universidad de La Frontera
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise program in people with Osteoarthritis, Knee, run by Universidad de La Frontera at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claudio Bascour, PhD (+56973871095, claudio.bascour@ufrontera.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
average of the last seven days (VAS-7D) (time frame: at the end of treatment (1 month), 1 month, and 3 months of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2022.