- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04303338
Masotherapy With Neural Tension in Patients With Parkinson's Disease
Effectiveness of Adding Neural Tension to Masotherapy in Patients With Parkinson's Disease
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Madrid, Spain
- Physiotherapy clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
To compare the effectiveness of masotherapy with neural tension and masotherapy with non-neural tension
Other Names:
|
Active Comparator: Masotherapy with non-neural tension
The investigators are going to practice a conventional upper limb massage
|
To compare the effectiveness of masotherapy with neural tension and masotherapy with non-neural tension
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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)
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.
|
Baseline 8 weeks and 1 month after intervention
|
Changes in the strength
Time Frame: Baseline 8 weeks and 1 month after intervention
|
Using the MicroFet 2 Hoggan
|
Baseline 8 weeks and 1 month after intervention
|
Changes in the manual dexterity
Time Frame: Baseline 8 weeks and 1 month after intervention
|
Using the Coin Rotation Task (CRT)
|
Baseline 8 weeks and 1 month after intervention
|
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.
|
Baseline 8 weeks and 1 month after intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEIM/HU/2019/45
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Parkinson Disease
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedParkinson Disease 6, Early-Onset | Parkinson Disease (Autosomal Recessive, Early Onset) 7, Human | Parkinson Disease Autosomal Recessive, Early Onset | Parkinson Disease, Autosomal Recessive Early-Onset, Digenic, Pink1/Dj1United States
-
ProgenaBiomeRecruitingParkinson Disease | Parkinsons Disease With Dementia | Parkinson-Dementia Syndrome | Parkinson Disease 2 | Parkinson Disease 3 | Parkinson Disease 4United States
-
King's College LondonGlaxoSmithKlineCompletedParkinson Disease | Idiopathic Parkinson Disease | Parkinson Disease, PARK8United Kingdom
-
Ohio State UniversityCompletedParkinson's Disease | Parkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease | Parkinson Disease, Idiopathic | Parkinson's Disease, IdiopathicUnited States
-
National Yang Ming UniversityUnknownEarly Onset Parkinson Disease | Early Stage Parkinson Disease
-
Michele Tagliati, MDRecruitingREM Sleep Behavior Disorder | Symptomatic Parkinson Disease | Pre-motor Parkinson DiseaseUnited States
-
Cedars-Sinai Medical CenterEnrolling by invitationREM Sleep Behavior Disorder | Symptomatic Parkinson Disease | Pre-motor Parkinson DiseaseUnited States
-
Mahatma Gandhi Institute of Medical SciencesCompletedStroke, Parkinson' s Disease, Neurological Impairments, Tele-rehabilitationIndia
-
Merck Sharp & Dohme LLCCompletedParkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease
-
University of DeustoCompletedPARKINSON DISEASE (Disorder)Spain
Clinical Trials on Masotherapy with neural tension and masotherapy with non-neural tension
-
Riphah International UniversityCompletedCervical RadiculopathyPakistan
-
University of FloridaNational Center for Complementary and Integrative Health (NCCIH)CompletedCarpal Tunnel SyndromeUnited States
-
University of ValenciaCompletedInjury of Musculoskeletal SystemSpain
-
Universidad Autonoma de MadridCentro Universitario La SalleCompleted
-
KTO Karatay UniversitySelcuk University; Nigde Omer Halisdemir UniversityNot yet recruitingMothers Who Have Babies Between 0-6 Months and Are Actively Breastfeeding | Mothers Who Complain of Back Pain Due to Breastfeeding (Getting 6 Points or More on VAS in the Mothers' Own Evaluation)
-
Universidade Federal do Rio Grande do NorteUnknown
-
Universidade Federal do Rio Grande do NorteCompleted
-
Wenzhou Medical UniversityNot yet recruitingCapsular Tension Ring | High MyopiaChina
-
Oslo University HospitalRecruiting
-
Professor Fernando Figueira Integral Medicine InstituteCompletedBurns | Hypertrophic ScarBrazil