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Clinical Trials/NCT04303338
NCT04303338CompletedNot Applicable

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

University of Jaén1 site in 1 country52 target enrollmentStarted: December 20, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
52
Locations
1
Primary Endpoint
Changes in the tremor

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Investigator)

Eligibility Criteria

Ages
50 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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.

Arms & Interventions

Masotherapy with non-neural tension

Active Comparator

The investigators are going to practice a conventional upper limb massage

Intervention: 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.

Intervention: Masotherapy with neural tension and masotherapy with non-neural tension (Procedure)

Outcomes

Primary Outcomes

Changes in the tremor

Time Frame: 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.

Secondary Outcomes

  • 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)

Investigators

Sponsor
University of Jaén
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Alexander Achalandabaso

Principal Investigator

University of Jaén

Study Sites (1)

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