跳至主要内容
临床试验/NCT04303338
NCT04303338已完成不适用

Effectiveness of Adding Neural Tension to Masotherapy in Patients With Parkinson's Disease

University of Jaén1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2019年12月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
52
试验地点
1
主要终点
Changes in the tremor

研究概览

简要总结

The objective of this study is to assess if the masotherapy with neural tension is more effective than non-neural tension to improve and reduce tremor in patients with Parkinson's disease. The project will be carried out in clinics, where both data collection, assessments and scales will be carried out, as well as the plan and intervention in which the neural tension massage therapy of the radial nerve will be applied to the first intervention group; and massage therapy without neural tension in the second group.

详细描述

In this study the investigators are going to compare the effectiveness of two treatments (masotherapy with neural tension and masotherapy with non-neural tension) in patients with Parkinson disease based on the improved of pain, tremor, functional and life quality.

The investigators are going to divide the number of volunteers in two groups. The first group is going to be treated during 8 weeks with conventional (non-neural tension) masotherapy in the upper limb, the other group is going to be treated with radial neural tension masotherapy during 8 weeks also. To apply the neural tension, the investigators position the patient's upper limb lowering the scapula, elbow extended, internal rotation glenohumeral, forearm pronation, bend and cubital deviation of the wrist, fingers bended and thumb adduction, and finally glenohumeral abduction.

To compare the results between the different groups, the investigators are going to value the patients 4 times, the first one before the beginning of the treatment, the second one and the end of the treatment, the third one after one month completing the treatment, and the last one after three months completing the treatment.

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
Single (Investigator)

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •People diagnosed with Parkinson disease in mild or moderate degree.
  • •Age between 50-80 years old.
  • •People who can answer the questionnaires without held.
  • •People who commit to attend the treatment assigned in the study.
  • •People with tremor that limit his/her functionality or cause discomfort.
  • •People who is not treated the upper limb

排除标准

  • •People with mental disease.
  • •People who do not sign the informed consent.
  • •People who present comorbidities that can affect the final result of the study.
  • •People whose medication is modified through the study.
  • •People who take medication whose secundary effect is the tremor appearance.
  • •People who is participating in other research studies.

研究组 & 干预措施

Masotherapy with non-neural tension

Active Comparator

The investigators are going to practice a conventional upper limb massage

干预措施: Masotherapy with neural tension and masotherapy with non-neural tension (Procedure)

Masotherapy with neural tension

Experimental

The investigators are going to massage the patient´s upper limb applying a radial nerve neural tension. In order to the upper limb should be positioned lowering the scapula, elbow extended, internal rotation glenohumeral, forearm pronation, bend and cubital deviation of the wrist, fingers bended and thumb adduction, and finally glenohumeral abduction.

干预措施: Masotherapy with neural tension and masotherapy with non-neural tension (Procedure)

结局指标

主要结局

Changes in the tremor

时间窗: Baseline and 1 month after intervention

Using the Unified Parkinson's Disease Ratin Scale (UPDRS). Each item is scored 0-4 (0= normal; 10= severe affectation) yielding a total between 0 and 159.

次要结局

  • Changes in the strength(Baseline 8 weeks and 1 month after intervention)
  • Changes in the pain: Visual Analog Scale (VAS)(Baseline 8 weeks and 1 month after intervention)
  • Changes in the health-related quality of life: Parkinson Disease Quality of Questionnaire (PDQ-39)(Baseline 8 weeks and 1 month after intervention)
  • Changes in the manual dexterity(Baseline 8 weeks and 1 month after intervention)

研究者

发起方
University of Jaén
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexander Achalandabaso

Principal Investigator

University of Jaén

研究点 (1)

Loading locations...

相似试验