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

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: Dry needling; Other: Sham dry Needling

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 Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Zaragoza, Spain, 50015
    • Asociación de Parkinson de Aragón

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dry needling; 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.	Other: Dry needling; Dry needling into spastic muscle; Other Names: DNHS technique
Sham Comparator: Sham Dry needling; 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.	Other: Sham dry Needling; Sham dry needling into spastic muscle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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	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 Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	Change between baseline (immediately before intervention) and follow-up at 1 week after intervention

Collaborators and Investigators

• Sponsor: Universidad San Jorge
• Collaborators: University of Castilla-La Mancha
• Investigators: Study Director: Elisabeth Bravo, Phd, University of Castilla-La Mancha

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): December 5, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: September 20, 2019
• First Submitted That Met QC Criteria: September 20, 2019
• First Posted (Actual): September 24, 2019

Study Record Updates

• Last Update Posted (Actual): January 13, 2020
• Last Update Submitted That Met QC Criteria: January 10, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Parkinson Disease; Dry needling; myofascial trigger point
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: DNHS_Parkinson

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No