Analysis of the Effectiveness of Dry Needling for Improving Gait in the Patient With Multiple Sclerosis: a Randomized Single-blind Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Change in Timed 25-Foot Walk (T25FW)
研究概览
简要总结
Multiple sclerosis (MS) is a chronic, inflammatory, autoimmune disease characterized by the appearance of lesions, characterized by heterogeneity in its pathological, clinical and radiological presentation. It has a significant socioeconomic impact, affecting interpersonal relationships and causing a significant reduction in quality of life.
Patients with MS suffer from a series of symptoms (ocular, spasticity, cerebellar, sensory, fatigue, depression) that may be independent of the course of the disease and their management significantly influences quality of life and also requires multidisciplinary therapeutic measures.
Physiotherapy and occupational therapy techniques are essential to reduce spasticity and prevent complications derived from it. Amongst physiotherapy techniques, we can find minimally invasive techniques such as dry needling which uses a fine filiform needle to penetrate the skin and mechanically break the myofascial trigger points, charactewrized by abnomral/pathological electrical activity. There have been previous studies with dry needling in stroke patients which have shown improvements in gait, but its effectiveness in other populations such as multiple sclerosis is still unclear.
In addition, dry needling has proven to be a cost-effective treatment for spasticity in patients with chronic and subacute stroke and could be an alternative to other pharmacological treatments, although more studies are necessary to compare both the effectiveness and the cost-effectiveness .
Recent studies carried out in patients with multiple sclerosis suggest that dry needling can improve mobility and gait speed. The main objective of the study is to analyze the effect of the application of a single session of dry needling in the lower limbs on the gait of patients with multiple sclerosis.
A prospective randomized parallel group clinical trial with blinded outcome assessment will be conducted. Participants will be recruited from the Hospital Universitario de Canarias.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having been diagnosed with Multiple Sclerosis in a period of more than two years before the study starts
- •Participate voluntarily and sign the informed consent.
- •Suffering from some type of hypertonia or spasticity in MMII that makes walking difficult, measured with Expanded Disability Status Scale>2 (Pyramidal section >2)
- •Age from 18 to 60 years old.
- •Not having phobia of needles.
排除标准
- •Not signing the informed consent.
- •Having a phobia of needles.
- •Presenting an outbreak at the start of the study or having presented any outbreak up to two months before the start of the study.
结局指标
主要结局
Change in Timed 25-Foot Walk (T25FW)
时间窗: inmediatly before intervention, inmediatly after intervention, a week after the intervention and a month after the intervention
is a quantitative mobility and leg function performance test based on a timed 25-walk. This is considered the "gold standard" to assess gait speed in MS patients. The test measures the time in seconds that the patient needs to walk 25 feet (7.5 meters).
次要结局
- Change in analog scale of quality of life(inmediatly beforeintervention, a week after intervention and a month after intervention)
- Change in The Time up and go test (TUG)(inmediatly before intervention, inmediatly after intervention, a week after the intervention and a month after the intervention)
- Change in Multiple Sclerosis Walking Scale (MSWS-12)(inmediatly before intervention, a week after the intervention and a month after the intervention)
- Change in The Multiple Sclerosis International QoL (Musiqol-54)(inmediatly before intervention and a month after the intervention)
研究者
Alberto Javier Ormazábal
Principal Investigator
Hospital Universitario de Canarias