Masotherapy With Neural Tension in Patients With Parkinson's Disease
Effectiveness of Adding Neural Tension to Masotherapy in Patients With Parkinson's Disease
1 other identifier
interventional
52
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable parkinson-disease
Started Dec 2019
Shorter than P25 for not_applicable parkinson-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 20, 2019
CompletedFirst Submitted
Initial submission to the registry
March 8, 2020
CompletedFirst Posted
Study publicly available on registry
March 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 16, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 13, 2020
CompletedOctober 23, 2020
October 1, 2020
3 months
March 8, 2020
October 22, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in the tremor
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.
Baseline and 1 month after intervention
Secondary Outcomes (4)
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 strength
Baseline 8 weeks and 1 month after intervention
Changes in the manual dexterity
Baseline 8 weeks and 1 month after intervention
Changes in the pain: Visual Analog Scale (VAS)
Baseline 8 weeks and 1 month after intervention
Study Arms (2)
Masotherapy with neural tension
EXPERIMENTALThe 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.
Masotherapy with non-neural tension
ACTIVE COMPARATORThe investigators are going to practice a conventional upper limb massage
Interventions
To compare the effectiveness of masotherapy with neural tension and masotherapy with non-neural tension
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Jaénlead
- University of Alcalacollaborator
Study Sites (1)
Physiotherapy clinic
Madrid, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Alexander Achalandabaso, PhD
University of Jaen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 8, 2020
First Posted
March 11, 2020
Study Start
December 20, 2019
Primary Completion
March 16, 2020
Study Completion
April 13, 2020
Last Updated
October 23, 2020
Record last verified: 2020-10