NCT04303338

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 20, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 11, 2020

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2020

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2020

Completed
Last Updated

October 23, 2020

Status Verified

October 1, 2020

Enrollment Period

3 months

First QC Date

March 8, 2020

Last Update Submit

October 22, 2020

Conditions

Keywords

Parkinson diseaseEssential tremorNeuromuscular TherapyMassageManual TherapyNeurodynamic

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Changes in the health-related quality of life: Parkinson Disease Quality of Questionnaire (PDQ-39)

    Baseline 8 weeks and 1 month after intervention

  • Changes in the strength

    Baseline 8 weeks and 1 month after intervention

  • Changes in the manual dexterity

    Baseline 8 weeks and 1 month after intervention

  • Changes in the pain: Visual Analog Scale (VAS)

    Baseline 8 weeks and 1 month after intervention

Study Arms (2)

Masotherapy with neural tension

EXPERIMENTAL

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

Masotherapy with non-neural tension

ACTIVE COMPARATOR

The investigators are going to practice a conventional upper limb massage

Procedure: Masotherapy with neural tension and masotherapy with non-neural tension

Interventions

To compare the effectiveness of masotherapy with neural tension and masotherapy with non-neural tension

Also known as: Neurodynamic
Masotherapy with neural tensionMasotherapy with non-neural tension

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physiotherapy clinic

Madrid, Spain

Location

MeSH Terms

Conditions

Parkinson DiseaseEssential Tremor

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Alexander Achalandabaso, PhD

    University of Jaen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 8, 2020

First Posted

March 11, 2020

Study Start

December 20, 2019

Primary Completion

March 16, 2020

Study Completion

April 13, 2020

Last Updated

October 23, 2020

Record last verified: 2020-10

Locations