Repetitive Transcranial Magnetic Stimulation Associated With Manual Therapy in Knee Ostearthritis Pain
试验速览
- 阶段
- 2 期
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Pain Rating Scale (NPRS)
研究概览
简要总结
In this study, the investigators wondered whether the association between high frequency repetitive transcranial magnetic stimulation (hf-rTMS) and manual therapy (peripheral and central approach) is more effective in reducing pain levels and modulation of cortical activity of chronic knee ostearthritis pain subjects than manual therapy alone (usual peripheral approach). For this purpose, patients included will be submitted to one session with active or sham hf-rTMS followed by a protocol of manual therapy. Besides that another active group will have the sequence of interventions exchanged (manual therapy followed by hf-rTMS) in order to investigate whether this may influence in the final outcomes.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of knee OA;
- •Absence of severe cognitive deficiency verified by the Mini Mental State Examination;
- •Meet the American College of Rheumatology criteria for idiopathic knee osteoarthritis.
排除标准
- •Individuals diagnosed with osteoporosis, fibromyalgia or other neurological disease;
- •Had an opioid or corticosteroid injection in the last 30 days;
- •Modified chronic pain medication in the last month before participating in the study;
- •History of knee surgery in the last six months;
- •Contraindications to the use of non-invasive brain stimulation, such as: metal implant on face or skull, history of seizure, cochlear implant.
结局指标
主要结局
Pain Rating Scale (NPRS)
时间窗: Until 30 days (before, after the interventions and until the last day with the same value of the first evaluation)
Is it used to quantify pain level, where 0 means no pain and 10 means worst pain possible. NPRS is recommended as the main endpoint in chronic pain studies and it has been established that a decrease of at least 2 points or 30% represents a minimal clinically important difference. The MDCI consists of the smaller variation in a clinical outcome perceived by the patient and that results in a relevant change in his state of health.
Pain
时间窗: Until one day (before and after the interventions)
Pain will be evaluated by pressure algometry before and after the interventions. It's a evaluation technique which aims to quantify through physical stimulation (pressure in the nociceptors) the capacity of pain perception and toleration. It will be used with the patient lying in supine and will have the purpose of measure the pressure pain threshold (PPT) in eight points around patellar region. Besides that, two control points will be adopted, one in anterior tibial muscle (five centimeters distal of anterior tibial tuberosity) and another in the extensor carpi radialis longus muscle (five centimeters distal to lateral humerus epicondyle). After marking, the algometer will be setted up 90° in contact with the skin and will be applied a 0,3 kgf/cm²/s pressure until the patient report pain by pressing a pen (Model/Brand: Algomed/Medoc). The measure will be done twice in the demarcated points with a two minutes interval between them. Will be considered a mean of the obtained values.
次要结局
- Cortical excitability(One day (before and after the interventions))
研究者
Kátia Monte-Silva
PhD
Universidade Federal de Pernambuco