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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04101214
• Other study ID #: DNHS_Parkinson
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2020
• Source: Universidad San Jorge
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 31, 2019
• Est. primary completion date: December 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• Dry needling
Dry needling into spastic muscle
• Sham dry Needling
Sham dry needling into spastic muscle

Locations

Country	Name	City	State
Spain	Asociación de Parkinson de Aragón	Zaragoza

Sponsors (2)

Lead Sponsor	Collaborator
Universidad San Jorge	University of Castilla-La Mancha

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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