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Clinical Trials/NCT04101214
NCT04101214
Completed
Not Applicable

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

Universidad San Jorge1 site in 1 country37 target enrollmentOctober 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
Universidad San Jorge
Enrollment
37
Locations
1
Primary Endpoint
6 minute walk test
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2019
End Date
December 31, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Universidad San Jorge
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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.

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

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

Secondary Outcomes

  • Modified Modified Ashworth score(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)(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(Change between baseline (immediately before intervention) and follow-up at 1 week after intervention)

Study Sites (1)

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