Parkinson DiseaseNCT04101214
Effects of Dry Needling on Function, Muscle Tone and Quality of Life in Parkinson's Disease
A study testing Dry needling in people with Parkinson Disease, run by Universidad San Jorge at 1 site in Spain.
Trial summary
Hypothesis: Dry needling in lower limbs produces a change in function (assessed by the 6 minute walk test, timed up and go, 10 meter walk test and unified scale for Parkinson's disease) and muscle tone (assessed by tonometry and the modified of Modified Ashworth scale(MMAS)) in patients with Parkinson's disease. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Dry needling
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2019to 31 Dec 2019
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with Parkinson by a neurologist
- Age: 50 - 90 years
- Presence of Hypertonia according to: MMAS score > 1 during movement of ankle dorsiflexion or knee flexion and extension
Who cannot join
- Degenerative diseases that may affect the results.
- Presence of fixed contractures.
- Fear of needles
- No tolerance to pain caused by dry needling
- No commitment to continuity
Trial locations and contacts
1 site in 1 country.
About this study
Hypothesis: Dry needling in lower limbs produces a change in function (assessed by the 6 minute walk test, timed up and go, 10 meter walk test and unified scale for Parkinson's disease) and muscle tone (assessed by tonometry and the modified of Modified Ashworth scale(MMAS)) in patients with Parkinson's disease.
The main objective of this study is to analyze the effect of dry needling on function and muscle tone in subjects with Parkinson disease.
The secondary objective is to analyze the longterm effects of dry needling on function and muscle tone in subjects with Parkinson disease.
Read the detailed description
Methods:
It is a double-blinded randomized clinical trial where subjects are patients from Zaragoza and have been diagnosed with Parkinson´disease by a neurologist.
Inclusion criteria:
- Patients diagnosed with Parkinson by a neurologist.
- Age: 50 - 90 years.
- Presence of Hypertonia according to: MMAS score > 1 during movement of ankle dorsiflexion or knee flexion and extension.
Exclusion criteria:
- Degenerative diseases that may affect the results.
- Presence of fixed contractures.
- Fear of needles.
- No tolerance to pain caused by dry needling
- No commitment to continuity.
- Attrition criteria
Attrition criteria:
- Adverse effects relate to the DNHS technique.
- Subject Uncooperative that prevents proper protocol execution performance -Voluntary decision of the patient.
Intervention:
There will be an intervention group (dry needling into the muscles of the lower limbs that present tone dysfunction according to an expert clinician) and a control group (sham dry needling). The intervention will be a unique session.
Dry needling technique will be performed by locating the taut band and the Myofascial Trigger Point by an expert clinician. After that, a thin needle (0,32x40mm) is introduced directly into a Myofascial Trigger Point with the aims to generate a "local twitch response" that are involuntary contractions of the muscle fibers. This puncture may reproduce patient's symptoms, and causes muscle relaxation to achieve at the same time the relief of muscle tension and pain and also to recover the metabolism of the muscle.
Assessment:
Outcome measures will include tone muscle measured by tonometry and the MMAS and functional clinical scales including: 6 minute walk test, timed up and go, 10 meter walk test and Unified Parkinson's Disease Rating Scale.
- Conditions
- Parkinson Disease
- Being tested
- Dry needling, Sham dry Needling
- Keywords
- Dry needling, Parkinson Disease, myofascial trigger point
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry needlingOther
Also called DNHS technique
Dry needling into spastic muscle
Sham dry NeedlingOther
Sham dry needling into spastic muscle
| Study group | Role | What they receive |
|---|---|---|
| Dry needling | Experimental | One session of dry needling technique will be applied by a physiotherapist specialized in the technique. Dry needling technique will be performed in the muscle of the lower limb whose MMAS score is >1 by locating a sensitive point within a taut band. After that, a thin needle (0,32x40mm) is introduced directly into those muscle that present spasticity, decide by the clinician expert. Receives: Other: Dry needling |
| Sham Dry needling | Sham comparator | A physiotherapist specialized in dry needling technique will use a sham needle in order to simulate the active intervention. Sham acupuncture uses non-penetrating needles.The palpation and evaluation of the spastic muscle will be exactly the same that in the active group. Receives: Other: Sham dry Needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minute walk test
It measures the maximum distance that the subject is able to travel in 6 minutes. It allows to obtain the speed of walking.
Measured: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). Change between baseline (immediately before intervention) and follow-up (at 1 week after intervention)
Timed up and go test
It measures patient mobility. The patient should get up from a chair with armrests, walk three meters, turn on himself, step back three meters and sit back down. If the patient takes less than 10s, it is considered normal mobility and more than 20s reduced mobility
Measured: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). Change between baseline (immediately before intervention) and follow-up (at 1 week after intervention)
10 meter walk test
It used to assess walking speed in meters/second (m/s) over a short distance
Measured: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). Change between baseline (immediately before intervention) and follow-up (at 1 week after intervention)
Secondary outcomes (3)
Modified Modified Ashworth score
Scale measuring Spasticity/Hypertonia. This scale ranges from 0 to 4 points for each muscle assessed, where 0 is no hypertonia/spasticity and 4 is the highest hypertonia/spasticity.
Measured: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). Change between baseline (immediately before intervention) and follow-up (at 1 week after intervention)
Tonometry (measurement of muscle tone with a device)
Muscle stiffness or muscle tone (Quadriceps, Hamstring, soleus and gastrocnemius). This device register different parameters like frequency, oscillation, etc that are related to tone, and start from 0 to an undefined number (depending on every muscle). It is a quantitative measurement.
It is a quantitative measurement.
Measured: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). Change between baseline (immediately before intervention) and follow-up (at 1 week after intervention)
Unified Parkinson's Disease Rating Scale
It measures the motor and cognitive function, the activities of daily life, as well as the possible complications that can alter the patient's life. The score ranges from 0 to 199, where 199 represents total disability and 0 no disability
Measured: Change between baseline (immediately before intervention) and follow-up at 1 week after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start1 Oct 2019
- Primary completion5 Dec 2019
- Study completion31 Dec 2019
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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad San Jorge
- Sponsor type
- University, hospital or other
- Collaborators
- University of Castilla-La Mancha
- Responsible party
- Sponsor
- Investigators
- Elisabeth Bravo, Phd, Study director, University of Castilla-La Mancha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04101214
- Sponsor's protocol ID
- DNHS_Parkinson
- Status last verified
- Jan 2020
- First submitted
- 20 Sep 2019
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dry Needling on Function, Muscle Tone and Quality of Life in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04101214
- Acronym / sponsor ID
- DNHS_Parkinson
- Conditions
- Parkinson Disease
- Keywords
- Dry needling, Parkinson Disease, myofascial trigger point
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Universidad San JorgeUniversity, hospital or other
- Collaborators
- University of Castilla-La Mancha
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 5 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 24 Sep 2019 (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.
Hypothesis: Dry needling in lower limbs produces a change in function (assessed by the 6 minute walk test, timed up and go, 10 meter walk test and unified scale for Parkinson's disease) and muscle tone (assessed by tonometry and the modified of Modified Ashworth scale(MMAS)) in patients with Parkinson's disease.
The main objective of this study is to analyze the effect of dry needling on function and muscle tone in subjects with Parkinson disease.
The secondary objective is to analyze the longterm effects of dry needling on function and muscle tone in subjects with Parkinson disease.
Detailed description
Methods:
It is a double-blinded randomized clinical trial where subjects are patients from Zaragoza and have been diagnosed with Parkinson´disease by a neurologist.
Inclusion criteria:
- Patients diagnosed with Parkinson by a neurologist.
- Age: 50 - 90 years.
- Presence of Hypertonia according to: MMAS score > 1 during movement of ankle dorsiflexion or knee flexion and extension.
Exclusion criteria:
- Degenerative diseases that may affect the results.
- Presence of fixed contractures.
- Fear of needles.
- No tolerance to pain caused by dry needling
- No commitment to continuity.
- Attrition criteria
Attrition criteria:
- Adverse effects relate to the DNHS technique.
- Subject Uncooperative that prevents proper protocol execution performance -Voluntary decision of the patient.
Intervention:
There will be an intervention group (dry needling into the muscles of the lower limbs that present tone dysfunction according to an expert clinician) and a control group (sham dry needling). The intervention will be a unique session.
Dry needling technique will be performed by locating the taut band and the Myofascial Trigger Point by an expert clinician. After that, a thin needle (0,32x40mm) is introduced directly into a Myofascial Trigger Point with the aims to generate a "local twitch response" that are involuntary contractions of the muscle fibers. This puncture may reproduce patient's symptoms, and causes muscle relaxation to achieve at the same time the relief of muscle tension and pain and also to recover the metabolism of the muscle.
Assessment:
Outcome measures will include tone muscle measured by tonometry and the MMAS and functional clinical scales including: 6 minute walk test, timed up and go, 10 meter walk test and Unified Parkinson's Disease Rating Scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry needling | Experimental | Other: Dry needlingOne session of dry needling technique will be applied by a physiotherapist specialized in the technique. Dry needling technique will be performed in the muscle of the lower limb whose MMAS score is >1 by locating a sensitive point within a taut band. After that, a thin needle (0,32x40mm) is introduced directly into those muscle that present spasticity, decide by the clinician expert. |
| Sham Dry needling | Sham comparator | Other: Sham dry NeedlingA physiotherapist specialized in dry needling technique will use a sham needle in order to simulate the active intervention. Sham acupuncture uses non-penetrating needles.The palpation and evaluation of the spastic muscle will be exactly the same that in the active group. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with Parkinson by a neurologist
- Age: 50 - 90 years
- Presence of Hypertonia according to: MMAS score > 1 during movement of ankle dorsiflexion or knee flexion and extension
Key exclusion criteria (5 listed)
- Degenerative diseases that may affect the results.
- Presence of fixed contractures.
- Fear of needles
- No tolerance to pain caused by dry needling
- No commitment to continuity
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 |
|---|---|---|
| Dry needlingAlso: DNHS techniqueDry needling into spastic muscle | Other | Dry needling |
| Sham dry NeedlingSham dry needling into spastic muscle | Other | Sham Dry needling |
Primary outcome
6 minute walk test
Time frame: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). Change between baseline (immediately before intervention) and follow-up (at 1 week after intervention)
It measures the maximum distance that the subject is able to travel in 6 minutes. It allows to obtain the speed of walking.
Timed up and go test
Time frame: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). Change between baseline (immediately before intervention) and follow-up (at 1 week after intervention)
It measures patient mobility. The patient should get up from a chair with armrests, walk three meters, turn on himself, step back three meters and sit back down. If the patient takes less than 10s, it is considered normal mobility and more than 20s reduced mobility
10 meter walk test
Time frame: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). Change between baseline (immediately before intervention) and follow-up (at 1 week after intervention)
It used to assess walking speed in meters/second (m/s) over a short distance
3 secondary outcomes
Modified Modified Ashworth score
Time frame: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). Change between baseline (immediately before intervention) and follow-up (at 1 week after intervention)
Tonometry (measurement of muscle tone with a device)
Time frame: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). Change between baseline (immediately before intervention) and follow-up (at 1 week after intervention)
Unified Parkinson's Disease Rating Scale
Time frame: Change between baseline (immediately before intervention) and follow-up at 1 week 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 13 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Elisabeth Bravo, Phd study director
University of Castilla-La Mancha
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry needling in people with Parkinson Disease, run by Universidad San Jorge 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 3 inclusion and 5 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 13 Jan 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. Some participants in this study may receive a placebo. 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?
6 minute walk test (time frame: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). Change between baseline (immediately before intervention) and follow-up (at 1 week after intervention)). The study lists 3 primary outcomes in all. 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 13 Jan 2020.