Transcutaneous Vagal Stimulation in Knee Osteoarthritis

Osteoarthritis, Knee Clinical Trial

— TRAVKO  

Official title:

Transcutaneous Vagal Stimulation in Knee Osteoarthritis (TRAVKO): Protocol of a Superiority, Outcome Assessor- and Participant-blind, Randomised Controlled Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04381624
• Other study ID #: FONIS SA19/0003
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: December 2022
• Source: Universidad de La Frontera
• Contact: Claudio Bascour, PhD
• Phone: +56973871095
• Email: claudio.bascour[@]ufrontera.cl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: March 1, 2024
• Est. primary completion date: December 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
Chile	Universidad de La Frontera	Temuco	La Araucania

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de La Frontera

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Kinesiophobia	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.	Baseline, at the end of treatment (1 month)
Other	Sleep Quality	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.	Baseline, at the end of treatment (1 month)
Other	Pain Catastrophism	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.	Baseline, at the end of treatment (1 month)
Other	Negative Affectivity	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.	Baseline, at the end of treatment (1 month)
Other	Pain Self-Efficacy	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.	Baseline, at the end of treatment (1 month)
Primary	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	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.	Baseline, at the end of treatment (1 month), 1 month, and 3 months of follow-up
Secondary	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.	Baseline, at the end of treatment (1 month), 1 month, and 3 months of follow-up
Secondary	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")	Baseline, at the end of treatment (1 month), 1 month, and 3 months of follow-up
Secondary	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")	Baseline, at the end of treatment (1 month), 1 month, and 3 months of follow-up
Secondary	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.	Baseline, at the end of treatment (1 month), 1 month, and 3 months of follow-up
Secondary	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'')	at the end of treatment (1 month), 1 month, and 3 months of follow-up
Secondary	Session attendance	physical therapist treatment notes	at the end of treatment (1 month)
Secondary	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	at the end of treatment (1 month)
Secondary	Gait speed test	Meters per second	Baseline, at the end of treatment (1 month)
Secondary	Standing and sitting in 30 seconds	Number of repetitions	Baseline, at the end of treatment (1 month)
Secondary	Time up and go	Seconds	Baseline, at the end of treatment (1 month)
Secondary	Unipodal stance task	Seconds	Baseline, at the end of treatment (1 month)