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

NCT04101214 | Completed

• 1 other identifier: DNHS_Parkinson
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Dry needling; Parkinson Disease; myofascial trigger point

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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 Arms (2)

Dry needling

EXPERIMENTAL

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

Sham Dry needling

SHAM COMPARATOR

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

Interventions

Dry needling OTHER

Dry needling into spastic muscle

Also known as: DNHS technique

Dry needling

Sham dry Needling OTHER

Sham dry needling into spastic muscle

Sham Dry needling

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad San Jorge: lead
• University of Castilla-La Mancha: collaborator

Study Sites (1)

Asociación de Parkinson de Aragón

Zaragoza, 50015, Spain

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Officials

• Elisabeth Bravo, Phd

  University of Castilla-La Mancha

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Masking is with sham dry needling, simulating to insert the needle, so no real masking 100%
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2019
• First Posted: September 24, 2019
• Study Start: October 1, 2019
• Primary Completion: December 5, 2019
• Study Completion: December 31, 2019
• Last Updated: January 13, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)