Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Masotherapy With Neural Tension in Patients With Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04303338
Recruitment Status : Completed
First Posted : March 11, 2020
Last Update Posted : October 23, 2020
Sponsor:
Collaborator:
University of Alcala
Information provided by (Responsible Party):
Alexander Achalandabaso, University of Jaén

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.

Layout table for study information
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

Resource links provided by the National Library of Medicine


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




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04303338


Locations
Layout table for location information
Spain
Physiotherapy clinic
Madrid, Spain
Sponsors and Collaborators
University of Jaén
University of Alcala
Investigators
Layout table for investigator information
Study Director: Alexander Achalandabaso, PhD University of Jaen
Layout table for additonal 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    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: October 2020

Layout table for additional information
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:
Layout table for MeSH terms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases