Efficacy of Magnetotherapy in Hand Erosive Osteoarthritis. A Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 主要终点
- Visual Analogue Scale (VAS)
研究概览
简要总结
Erosive arthritis (EA) is an unusual pathology. There is no definitive treatment and the conventional one has little efficacy. Despite using magnetotherapy (MGT) as a treatment, there is no evidence supporting its use.
详细描述
The aim of the study is to evaluate the efficacy of MGT in patients suffering from hand EA, compared to placebo, in terms of pain (assessed by Visual Analog Scale (VAS)) and functionality (assessed by The Disabilities of the Arm, Shoulder and Hand (DASH) score) during the treatment and after a 3-months period. Secondarily, rigidity (Modified Kapandji Index), grip strength (JAMAR dynamometry) and quality of life (SF-36 questionnaire) were assessed. Treatment safety will also be evaluated.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes older than 18 years with symptomatic hand erosive osteoarthritis for more than 6 months.
- •Patients receiving treatment or not for their hand pathology.
- •Patients suffering from hand chronic pain due to their pathology and scoring VAS equal or greater than 4/
- •Patients who voluntarily signed the informed consent and agree to participate in the study.
排除标准
- •Pregnancy
- •Patients with pacemaker or similar devices
- •Pacients with cognitive dysfunction.
- •Patients with psychiatric pathologies unable to comply with the treatment and follow-up
- •Patients with active oncological and / or infectious pathology
- •Patients with previous magnetotherapy or paraffin treatment in the last year
结局指标
主要结局
Visual Analogue Scale (VAS)
时间窗: Change from baseline pain at the end of the intervention and 3 months after the end of intervention.
The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which measures subjective characteristics or attitudes that cannot be directly measured, like pain. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points: one meaning no pain and the opposite one meaning the worst pain.
次要结局
- The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire(Before starting the intervention, at the end of the intervention and 3 months after the end of intervention.)
- Modified Kapandji Index(Before starting the intervention, at the end of the intervention and 3 months after the end of intervention.)
- JAMAR dynamometry(Before starting the intervention, at the end of the intervention and 3 months after the end of intervention.)
- SF-36 questionnaire(Before starting the intervention, at the end of the intervention and 3 months after the end of intervention.)
研究者
Anna Boada-Pladellorens
MD
Hospital Mutua de Terrassa