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临床试验/NCT05351957
NCT05351957已完成不适用

Dry Needling for Treating Spasticity in Multiple Sclerosis

Hospital Universitario de Canarias2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年2月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
Change in 9HOLD PEG TEST score

研究概览

简要总结

The aim of the study is to evaluate the efficacy of dry needling (DN) in the treatment of spasticity in patients with multiple sclerosis (MS). [Participants and Methods] participants with MS, with no evidence of a relapse in the last four weeks and with an EDSS (Expanded Disability Sta- tus Scale) greater than 2.5 points (related with pyramidal score) were recruited. DN was performed in lower limbs for 12 consecutive sessions and evaluated with: EDSS (Pyramidal item), Time up and go (TUG), 25 foot, 9hold peg test (9HPT) and the improvement or not in the quality of life (MSQol54) was verified before and after treatment. A follow up visit was carried out to assess improvement.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Being a patient diagnosed with multiple sclerosis.
  • Being over 18 years of age and less than or equal to 60 years of age.
  • Having a score equal to or greater than 2 in the EDSS.
  • They need to have a measurement in the following functional systems: P (pyramidal) >2, CT (brainstem), gait >2 and sphincter >
  • They need to present hypertonia or contractures of the muscles selected for the dry needling, the pain expressed by the patients must be a consequence of spastic processes, have hourly availability to receive therapies and not have needle phobias.

排除标准

  • Having a disease associated with multiple sclerosis that is incompatible with dry needling.
  • Being in relapse, or having suffered it in the thirty days prior to starting the treatment. program or taking medications that are contraindicated with the technique applied in the study, (oral anticoagulants.)

结局指标

主要结局

Change in 9HOLD PEG TEST score

时间窗: inmediatly before and inmediatly after intervention

This consists of placing the pegs in the corresponding holes of the 9 holes in the table in the shortest possible time (seconds)

Change in Multiple sclerosis Quality of life-54 (MSQol54) score

时间窗: inmediatly before and inmediatly after intervention

questionnaire of 54 items measuring the quality of life of the patient. It can be self-administered or hetero-administered and both physical and mental aspects are measured. Within these there are subscales: among them quality of life in general. Two summary scores, physical health and mental health, can be derived from a weighted combination of scale scores. They range from 0 to 100, where 100 is the highest quality of life (both for physical and mental health)

Change in Time up and go test score

时间窗: inmediatly before and inmediatly after intervention

The participants sit in a chair with their backs supported by the back of the chair and their arms resting on the armrests. The participants are asked to get up from the chair and walk a distance of 3 meters, then the patients turn on themselves (360°), walk back to the chair and sit down again (seconds)

Change in 25 foot walk score

时间窗: inmediatly before and inmediatly after intervention

patients must walk a distance of 7.25 meters at the fastest and safest speed for them (seconds)

Change in Expanded Disability Status Scale (EDSS) score

时间窗: inmediatly before and inmediatly after intervention

Each item is valued individually and a score is given, which will then outline the patient's total EDSS ranging from 0 to 10, for use in the exploration sessions. All scans were carried out by a blind explorer.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alberto Javier Ormazábal

Physiotherapist

Hospital Universitario de Canarias

研究点 (2)

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