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

NCT ID: NCT04101214

Last Updated: 2020-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2019-12-31

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Dry needling

Intervention Type: OTHER

Dry needling into spastic muscle

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.

Group Type: SHAM_COMPARATOR

Sham dry Needling

Intervention Type: OTHER

Sham dry needling into spastic muscle

Interventions

Dry needling

Dry needling into spastic muscle

Intervention Type: OTHER

Sham dry Needling

Sham dry needling into spastic muscle

Intervention Type: OTHER

Other Intervention Names

DNHS technique

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Castilla-La Mancha

OTHER

Sponsor Role: collaborator

Universidad San Jorge

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elisabeth Bravo, Phd

Role: STUDY_DIRECTOR

University of Castilla-La Mancha

Locations

Asociación de Parkinson de Aragón

Zaragoza, , Spain

Countries

Spain

Other Identifiers

DNHS_Parkinson

Identifier Type: -

Identifier Source: org_study_id