Masotherapy With Neural Tension in Patients With Parkinson's Disease

• ClinicalTrials.gov Identifier: NCT04303338
• Recruitment Status: Completed
• First Posted: March 11, 2020
• Last Update Posted: October 23, 2020
• Sponsor: University of Jaén
• Collaborator: University of Alcala
• Information provided by (Responsible Party): Alexander Achalandabaso, University of Jaén

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.

Condition or disease	Intervention/treatment	Phase
Parkinson Disease	Procedure: Masotherapy with neural tension and masotherapy with non-neural tension	Not Applicable

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 (Clinical Trial)
• Actual Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Effectiveness of Adding Neural Tension to Masotherapy in Patients With Parkinson's Disease
• Actual Study Start Date: December 20, 2019
• Actual Primary Completion Date: March 16, 2020
• Actual Study Completion Date: April 13, 2020

Arms and Interventions

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 Name: 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 Name: Neurodynamic

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Changes in the health-related quality of life: Parkinson Disease Quality of Questionnaire (PDQ-39) [ Time Frame: Baseline 8 weeks and 1 month after intervention ]
   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.
2. Changes in the strength [ Time Frame: Baseline 8 weeks and 1 month after intervention ]
   Using the MicroFet 2 Hoggan
3. Changes in the manual dexterity [ Time Frame: Baseline 8 weeks and 1 month after intervention ]
   Using the Coin Rotation Task (CRT)
4. Changes in the pain: Visual Analog Scale (VAS) [ Time Frame: Baseline 8 weeks and 1 month after intervention ]
   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.

Eligibility Criteria

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

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.

Contacts and Locations

Locations

Spain

Physiotherapy clinic

Madrid, Spain

Sponsors and Collaborators

University of Jaén

University of Alcala

Investigators

• Study Director: Alexander Achalandabaso, PhD; University of Jaen

More Information

• Responsible Party: Alexander Achalandabaso, Principal Investigator, University of Jaén
• ClinicalTrials.gov Identifier: NCT04303338
• Other Study ID Numbers: CEIM/HU/2019/45
• First Posted: March 11, 2020
• Last Update Posted: October 23, 2020
• Last Verified: October 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alexander Achalandabaso, University of Jaén:

Parkinson disease; Essential tremor; Neuromuscular Therapy; Massage; Manual Therapy; Neurodynamic

Additional relevant MeSH terms:

Parkinson Disease; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Neurodegenerative Diseases