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Completed

NCT Number: NCT04101214

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asociación de Parkinson de Aragón

Zaragoza, 50015, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dry needling

Other

Dry needling into spastic muscle

Other names: DNHS technique

Sham dry needling

Other

Sham dry needling into spastic muscle

Primary outcomes

  1. 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.

  2. 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

  3. 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

Secondary outcomes

  1. 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)

    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.

  2. 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)

    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.

  3. Unified Parkinson's Disease Rating Scale

    Time frame: Change between baseline (immediately before intervention) and follow-up at 1 week after intervention

    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

Sponsors and collaborators

Lead sponsor

Universidad San Jorge

Other

Collaborators

  • University of Castilla-La Mancha

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 24, 2019
Registry last updated
Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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