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Effects of Dry Needling on Function, Muscle Tone and Quality of Life in Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dry needling
Sham dry Needling
Sponsored by
Universidad San Jorge
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Dry needling, Parkinson Disease, myofascial trigger point

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Asociación de Parkinson de Aragón

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Dry needling

Sham Dry needling

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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
10 meter walk test
It used to assess walking speed in meters/second (m/s) over a short distance

Secondary Outcome Measures

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.
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.
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

Full Information

First Posted
September 20, 2019
Last Updated
January 10, 2020
Sponsor
Universidad San Jorge
Collaborators
University of Castilla-La Mancha
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1. Study Identification

Unique Protocol Identification Number
NCT04101214
Brief Title
Effects of Dry Needling on Function, Muscle Tone and Quality of Life in Parkinson's Disease
Official Title
Effects of Dry Needling on Function, Muscle Tone and Quality of Life in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
December 5, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad San Jorge
Collaborators
University of Castilla-La Mancha

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Dry needling, Parkinson Disease, myofascial trigger point

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Masking is with sham dry needling, simulating to insert the needle, so no real masking 100%
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dry needling
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham Dry needling
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Dry needling
Other Intervention Name(s)
DNHS technique
Intervention Description
Dry needling into spastic muscle
Intervention Type
Other
Intervention Name(s)
Sham dry Needling
Intervention Description
Sham dry needling into spastic muscle
Primary Outcome Measure Information:
Title
6 minute walk test
Description
It measures the maximum distance that the subject is able to travel in 6 minutes. It allows to obtain the speed of walking.
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)
Title
Timed up and go test
Description
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
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)
Title
10 meter walk test
Description
It used to assess walking speed in meters/second (m/s) over a short distance
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)
Secondary Outcome Measure Information:
Title
Modified Modified Ashworth score
Description
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.
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)
Title
Tonometry (measurement of muscle tone with a device)
Description
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.
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)
Title
Unified Parkinson's Disease Rating Scale
Description
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
Time Frame
Change between baseline (immediately before intervention) and follow-up at 1 week after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisabeth Bravo, Phd
Organizational Affiliation
University of Castilla-La Mancha
Official's Role
Study Director
Facility Information:
Facility Name
Asociación de Parkinson de Aragón
City
Zaragoza
ZIP/Postal Code
50015
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Dry Needling on Function, Muscle Tone and Quality of Life in Parkinson's Disease

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