Transcutaneous Vagal Stimulation in Knee Osteoarthritis (TRAVKO): Protocol of a Superiority, Outcome Assessor- and Participant-blind, Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- average of the last seven days (VAS-7D)
研究概览
简要总结
This study will evaluate the efficacy of Transcutaneous Vagal Stimulation in people whit knee osteoarthritis.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
average of the last seven days (VAS-7D)
时间窗: 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.
次要结局
- Quality of life in older adults(Baseline, at the end of treatment (1 month), 1 month, and 3 months of follow-up)
- Global change(at the end of treatment (1 month), 1 month, and 3 months of follow-up)
- Gait speed test(Baseline, at the end of treatment (1 month))
- Standing and sitting in 30 seconds(Baseline, at the end of treatment (1 month))
- Time up and go(Baseline, at the end of treatment (1 month))
- Pain-related interference(Baseline, at the end of treatment (1 month), 1 month, and 3 months of follow-up)
- Adverse Events(at the end of treatment (1 month))
- intensity of the pain at rest (VAS-R) and walking on flat ground (VAS-W)(Baseline, at the end of treatment (1 month), 1 month, and 3 months of follow-up)
- Functional capacity(Baseline, at the end of treatment (1 month), 1 month, and 3 months of follow-up)
- Pain-related distress(Baseline, at the end of treatment (1 month), 1 month, and 3 months of follow-up)
- Unipodal stance task(Baseline, at the end of treatment (1 month))
- Session attendance(at the end of treatment (1 month))
研究者
Germán Gálvez García
PhD
Universidad de La Frontera