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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise program | Other | exercise program in 12 sessions, of approximately one hour, distributed in 3 sessions per week during a month |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Sleep Quality |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claudio Bascour, PhD | Contact | +56973871095 | claudio.bascour@ufrontera.cl | |
| Claudio Muñoz, PhD | Contact | +56452325795 | claudio.munoz@ufrontera.cl |
| Name | Affiliation | Role |
|---|---|---|
| Claudio Bascour, PhD | Universidad de La Frontera | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad de La Frontera | Temuco | La Araucania | 4781176 | Chile |
Individual participant data that underlie the results reported in the main results article, after deidentification (text, tables, figures, and appendices).
Beginning 3 months following main results article publication
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
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010146 | Pain |
| D000377 | Agnosia |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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randomised controlled, two-arm, double-blind
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| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Session attendance | physical therapist treatment notes | 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 | at the end of treatment (1 month) |
| Gait speed test | Meters per second | Baseline, at the end of treatment (1 month) |
| Standing and sitting in 30 seconds | Number of repetitions | Baseline, at the end of treatment (1 month) |
| Time up and go | Seconds | Baseline, at the end of treatment (1 month) |
| Unipodal stance task | Seconds | Baseline, at the end of treatment (1 month) |
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) |
| 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) |
| 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) |
| 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) |
| D012216 |
| Rheumatic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D001519 | Behavior |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |