Back to resultsTranscutaneous Vagal Stimulation in Knee Osteoarthritis (TRAVKO)
Primary Purpose
Osteoarthritis, Knee
Status
Not yet recruiting
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Exercise program
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring pain, pain management, transcutaneous vagal stimulation, exercise
Eligibility Criteria
Inclusion Criteria:
- 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 of at least 30 mm on the EVA 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.
Exclusion Criteria:
- 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, stroke, generalized rheumatology, diabetes 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;
- Use of oral steroids or opioids in the last 4 weeks;
- 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.
Sites / Locations
- Universidad de La Frontera
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Transcutaneous Vagal Stimulation
Sham Transcutaneous Vagal Stimulation
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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")
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")
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.
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'')
Session attendance
physical therapist treatment notes
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
Gait speed test
Meters per second
Standing and sitting in 30 seconds
Number of repetitions
Time up and go
Seconds
Unipodal stance task
Seconds
Full Information
NCT ID
NCT04381624
First Posted
April 18, 2020
Last Updated
December 9, 2022
Sponsor
Universidad de La Frontera
1. Study Identification
Unique Protocol Identification Number
NCT04381624
Brief Title
Transcutaneous Vagal Stimulation in Knee Osteoarthritis
Acronym
TRAVKO
Official Title
Transcutaneous Vagal Stimulation in Knee Osteoarthritis (TRAVKO): Protocol of a Superiority, Outcome Assessor- and Participant-blind, Randomised Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2023 (Anticipated)
Primary Completion Date
December 25, 2023 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de La Frontera
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
pain, pain management, transcutaneous vagal stimulation, exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomised controlled, two-arm, double-blind
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transcutaneous Vagal Stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham Transcutaneous Vagal Stimulation
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise program
Intervention Description
exercise program in 12 sessions, of approximately one hour, distributed in 3 sessions per week during a month
Primary Outcome Measure Information:
Title
average of the last seven days (VAS-7D)
Description
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.
Time Frame
at the end of treatment (1 month), 1 month, and 3 months of follow-up
Secondary Outcome Measure Information:
Title
intensity of the pain at rest (VAS-R) and walking on flat ground (VAS-W)
Description
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.
Time Frame
Baseline, at the end of treatment (1 month), 1 month, and 3 months of follow-up
Title
Functional capacity
Description
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.
Time Frame
Baseline, at the end of treatment (1 month), 1 month, and 3 months of follow-up
Title
Pain-related interference
Description
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")
Time Frame
Baseline, at the end of treatment (1 month), 1 month, and 3 months of follow-up
Title
Pain-related distress
Description
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")
Time Frame
Baseline, at the end of treatment (1 month), 1 month, and 3 months of follow-up
Title
Quality of life in older adults
Description
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.
Time Frame
Baseline, at the end of treatment (1 month), 1 month, and 3 months of follow-up
Title
Global change
Description
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'')
Time Frame
at the end of treatment (1 month), 1 month, and 3 months of follow-up
Title
Session attendance
Description
physical therapist treatment notes
Time Frame
at the end of treatment (1 month)
Title
Adverse Events
Description
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
Time Frame
at the end of treatment (1 month)
Title
Gait speed test
Description
Meters per second
Time Frame
Baseline, at the end of treatment (1 month)
Title
Standing and sitting in 30 seconds
Description
Number of repetitions
Time Frame
Baseline, at the end of treatment (1 month)
Title
Time up and go
Description
Seconds
Time Frame
Baseline, at the end of treatment (1 month)
Title
Unipodal stance task
Description
Seconds
Time Frame
Baseline, at the end of treatment (1 month)
Other Pre-specified Outcome Measures:
Title
Kinesiophobia
Description
It will be evaluated using the Kinesiophobia TAMPA Scale. It is expressed on a scale of 11 to 44 points, where the highest score is related to the highest level of kinesiophobia.
Time Frame
Baseline, at the end of treatment (1 month)
Title
Sleep Quality
Description
Sleep quality will be measured through the Pittsburgh Sleep Quality Index (PSQI). Sleep quality score is express in a scale from 0 to 21 points, where the highest score is related with worst sleep quality.
Time Frame
Baseline, at the end of treatment (1 month)
Title
Pain Catastrophism
Description
This will be evaluated using the Pain Catastrophism Scale. It is expressed on a scale of 0 to 52 points, where the highest score is related to the highest level of catastrophism.
Time Frame
Baseline, at the end of treatment (1 month)
Title
Negative Affectivity
Description
This will be evaluated using Depression, Anxiety and Stress Scale - 21 (DASS-21). The scale is expressed as a score from 0 to 63 points. Higher score reflects greater negative affectivity.
Time Frame
Baseline, at the end of treatment (1 month)
Title
Pain Self-Efficacy
Description
This will be evaluated using the Pain self-efficacy questionnaire. The scale is expressed from 0 to 60 points. Higher score reflects greater perception of self-efficacy.
Time Frame
Baseline, at the end of treatment (1 month)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claudio Bascour, PhD
Phone
+56973871095
Email
claudio.bascour@ufrontera.cl
First Name & Middle Initial & Last Name or Official Title & Degree
Claudio Muñoz, PhD
Phone
+56452325795
Email
claudio.munoz@ufrontera.cl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudio Bascour, PhD
Organizational Affiliation
Universidad de La Frontera
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad de La Frontera
City
Temuco
State/Province
La Araucania
ZIP/Postal Code
4781176
Country
Chile
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudio Bascour, PhD
Phone
+56452325795
Email
claudio.bascour@ufrontera.cl
First Name & Middle Initial & Last Name & Degree
Claudio Muñoz, PhD
Phone
+56452325795
Email
claudio.munoz@ufrontera.cl
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in the main results article, after deidentification (text, tables, figures, and appendices).
IPD Sharing Time Frame
Beginning 3 months following main results article publication
IPD Sharing 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
Learn more about this trial
Transcutaneous Vagal Stimulation in Knee Osteoarthritis
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