Parkinson DiseaseNCT04303338
Masotherapy With Neural Tension in Patients With Parkinson's Disease
A study testing Masotherapy with neural tension and masotherapy with non-neural tension in people with Parkinson Disease, run by University of Jaén at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Masotherapy with neural tension and masotherapy with non-neural tension
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSpain
- Study dates
- 20 Dec 2019to 13 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Adding Neural Tension to Masotherapy in Patients With Parkinson's Disease
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Masotherapy with neural tension and masotherapy with non-neural tension
- Keywords
- Parkinson disease, Essential tremor, Neuromuscular Therapy, Massage, Manual Therapy, Neurodynamic
- Medical subject headings
- Parkinson Disease, Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Masotherapy with neural tension and masotherapy with non-neural tensionProcedure or surgery
Also called Neurodynamic
To compare the effectiveness of masotherapy with neural tension and masotherapy with non-neural tension
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Procedure: Masotherapy with neural tension and masotherapy with non-neural tension |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 1 month after intervention
Secondary outcomes (4)
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.
Measured: Baseline 8 weeks and 1 month after intervention
Changes in the strength
Using the MicroFet 2 Hoggan
Measured: Baseline 8 weeks and 1 month after intervention
Changes in the manual dexterity
Using the Coin Rotation Task (CRT)
Measured: Baseline 8 weeks and 1 month after intervention
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.
Measured: Baseline 8 weeks and 1 month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start20 Dec 2019
- Primary completion16 Mar 2020
- Study completion13 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jaén
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alcala
- Responsible party
- Principal investigator, Alexander Achalandabaso, University of Jaén
- Investigators
- Alexander Achalandabaso, PhD, Study director, University of Jaen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04303338
- Sponsor's protocol ID
- CEIM/HU/2019/45
- Status last verified
- Oct 2020
- First submitted
- 8 Mar 2020
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Adding Neural Tension to Masotherapy in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04303338
- Acronym / sponsor ID
- CEIM/HU/2019/45
- Conditions
- Parkinson Disease
- Keywords
- Parkinson disease, Essential tremor, Neuromuscular Therapy, Massage, Manual Therapy, Neurodynamic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Collaborators
- University of Alcala
- Study start
- 20 Dec 2019 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 13 Apr 2020 (actual)
- First posted
- 11 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Masotherapy with neural tension | Experimental | Procedure: Masotherapy with neural tension and masotherapy with non-neural tensionThe 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. |
| Masotherapy with non-neural tension | Active comparator | Procedure: Masotherapy with neural tension and masotherapy with non-neural tensionThe investigators are going to practice a conventional upper limb massage |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Masotherapy with neural tension and masotherapy with non-neural tensionAlso: NeurodynamicTo compare the effectiveness of masotherapy with neural tension and masotherapy with non-neural tension | Procedure or surgery | Masotherapy with neural tension, Masotherapy with non-neural tension |
Primary outcome
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.
4 secondary outcomes
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
Changes in the strength
Time frame: Baseline 8 weeks and 1 month after intervention
Changes in the manual dexterity
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Achalandabaso, PhD study director
University of Jaen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Masotherapy with neural tension and masotherapy with non-neural tension in people with Parkinson Disease, run by University of Jaén at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the tremor (time frame: Baseline and 1 month after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2020.