Masotherapy With Neural Tension in Patients With Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04303338
• Other study ID #: CEIM/HU/2019/45
• Status: Completed
• Phase: N/A
• Start date: December 20, 2019
• Est. completion date: April 13, 2020

Study information

• Verified date: October 2020
• Source: University of Jaén
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: April 13, 2020
• Est. primary completion date: March 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
Spain	Physiotherapy clinic	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
University of Jaén	University of Alcala

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Changes in the strength	Using the MicroFet 2 Hoggan	Baseline 8 weeks and 1 month after intervention
Secondary	Changes in the manual dexterity	Using the Coin Rotation Task (CRT)	Baseline 8 weeks and 1 month after intervention
Secondary	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