Masotherapy With Neural Tension in Patients With Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Masotherapy with neural tension and masotherapy with non-neural tension
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson disease, Essential tremor, Neuromuscular Therapy, Massage, Manual Therapy, Neurodynamic
Eligibility Criteria
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.
Sites / Locations
- Physiotherapy clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Masotherapy with neural tension
Masotherapy with non-neural tension
Arm Description
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.
The investigators are going to practice a conventional upper limb massage
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Changes in the health-related quality of life: Parkinson Disease Quality of Questionnaire (PDQ-39)
Using the Parkinson Disease Quality of Questionnaire (PDQ-39). Each item is scored 0-4 (0= better life quality; 4= bad life quality) yielding a total between 0 and 156.
Changes in the strength
Using the MicroFet 2 Hoggan
Changes in the manual dexterity
Using the Coin Rotation Task (CRT)
Changes in the pain: Visual Analog Scale (VAS)
Using the Visual Analog Scale (VAS). Each item is scored 0-10 (0= no pain; 10= the major pain that the patient can imagine) yielding a total between 0 and 10.
Full Information
NCT ID
NCT04303338
First Posted
March 8, 2020
Last Updated
October 22, 2020
Sponsor
University of Jaén
Collaborators
University of Alcala
1. Study Identification
Unique Protocol Identification Number
NCT04303338
Brief Title
Masotherapy With Neural Tension in Patients With Parkinson's Disease
Official Title
Effectiveness of Adding Neural Tension to Masotherapy in Patients With Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
December 20, 2019 (Actual)
Primary Completion Date
March 16, 2020 (Actual)
Study Completion Date
April 13, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jaén
Collaborators
University of Alcala
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson disease, Essential tremor, Neuromuscular Therapy, Massage, Manual Therapy, Neurodynamic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Masotherapy with neural tension
Arm Type
Experimental
Arm Description
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.
Arm Title
Masotherapy with non-neural tension
Arm Type
Active Comparator
Arm Description
The investigators are going to practice a conventional upper limb massage
Intervention Type
Procedure
Intervention Name(s)
Masotherapy with neural tension and masotherapy with non-neural tension
Other Intervention Name(s)
Neurodynamic
Intervention Description
To compare the effectiveness of masotherapy with neural tension and masotherapy with non-neural tension
Primary Outcome Measure Information:
Title
Changes in the tremor
Description
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.
Time Frame
Baseline and 1 month after intervention
Secondary Outcome Measure Information:
Title
Changes in the health-related quality of life: Parkinson Disease Quality of Questionnaire (PDQ-39)
Description
Using the Parkinson Disease Quality of Questionnaire (PDQ-39). Each item is scored 0-4 (0= better life quality; 4= bad life quality) yielding a total between 0 and 156.
Time Frame
Baseline 8 weeks and 1 month after intervention
Title
Changes in the strength
Description
Using the MicroFet 2 Hoggan
Time Frame
Baseline 8 weeks and 1 month after intervention
Title
Changes in the manual dexterity
Description
Using the Coin Rotation Task (CRT)
Time Frame
Baseline 8 weeks and 1 month after intervention
Title
Changes in the pain: Visual Analog Scale (VAS)
Description
Using the Visual Analog Scale (VAS). Each item is scored 0-10 (0= no pain; 10= the major pain that the patient can imagine) yielding a total between 0 and 10.
Time Frame
Baseline 8 weeks and 1 month after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Achalandabaso, PhD
Organizational Affiliation
University of Jaen
Official's Role
Study Director
Facility Information:
Facility Name
Physiotherapy clinic
City
Madrid
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Masotherapy With Neural Tension in Patients With Parkinson's Disease
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