Masotherapy With Neural Tension in Patients With Parkinson's Disease

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

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Procedure: Masotherapy with neural tension and masotherapy with non-neural tension

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 Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain
    • Physiotherapy Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Masotherapy with neural tension; 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.	Procedure: Masotherapy with neural tension and masotherapy with non-neural tension; To compare the effectiveness of masotherapy with neural tension and masotherapy with non-neural tension; Other Names: Neurodynamic
Active Comparator: Masotherapy with non-neural tension; The investigators are going to practice a conventional upper limb massage	Procedure: Masotherapy with neural tension and masotherapy with non-neural tension; To compare the effectiveness of masotherapy with neural tension and masotherapy with non-neural tension; Other Names: Neurodynamic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline 8 weeks and 1 month after intervention
Changes in the strength	Using the MicroFet 2 Hoggan	Baseline 8 weeks and 1 month after intervention
Changes in the manual dexterity	Using the Coin Rotation Task (CRT)	Baseline 8 weeks and 1 month after intervention
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.	Baseline 8 weeks and 1 month after intervention

Collaborators and Investigators

• Sponsor: University of Jaén
• Collaborators: University of Alcala

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2019
• Primary Completion (Actual): March 16, 2020
• Study Completion (Actual): April 13, 2020

Study Registration Dates

• First Submitted: March 8, 2020
• First Submitted That Met QC Criteria: March 10, 2020
• First Posted (Actual): March 11, 2020

Study Record Updates

• Last Update Posted (Actual): October 23, 2020
• Last Update Submitted That Met QC Criteria: October 22, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Parkinson disease; Massage; Essential tremor; Manual Therapy; Neuromuscular Therapy; Neurodynamic
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: CEIM/HU/2019/45

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No