This study will evaluate the efficacy of Transcutaneous Vagal Stimulation in people whit knee osteoarthritis.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
70
exercise program in 12 sessions, of approximately one hour, distributed in 3 sessions per week during a month
Universidad de La Frontera
Temuco, La Araucania, Chile
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.
Time frame: at the end of treatment (1 month), 1 month, and 3 months of follow-up
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.
Time frame: 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.
Time frame: 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")
Time frame: 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")
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Time frame: 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.
Time frame: 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'')
Time frame: at the end of treatment (1 month), 1 month, and 3 months of follow-up
Session attendance
physical therapist treatment notes
Time frame: 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
Time frame: at the end of treatment (1 month)
Gait speed test
Meters per second
Time frame: Baseline, at the end of treatment (1 month)
Standing and sitting in 30 seconds
Number of repetitions
Time frame: Baseline, at the end of treatment (1 month)
Time up and go
Seconds
Time frame: Baseline, at the end of treatment (1 month)
Unipodal stance task
Seconds
Time frame: Baseline, at the end of treatment (1 month)