Clinical trial NCT04101214: Effects of Dry Needling on Function, Muscle Tone and Quality of Life in Parkinson's Disease
Official title: Effects of Dry Needling on Function, Muscle Tone and Quality of Life in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Dry needling
Parkinson Disease
myofascial trigger point
Lead sponsor: Universidad San Jorge
Sponsor class: OTHER
Collaborators: name: University of Castilla-La Mancha
First posted: 2019-09-24
Enrollment: 37
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 6 minute walk test
timeFrame: 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)
measure: Timed up and go test
timeFrame: 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)
measure: 10 meter walk test
timeFrame: 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:
measure: Modified Modified Ashworth score
timeFrame: 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)
measure: Tonometry (measurement of muscle tone with a device)
timeFrame: 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)
measure: Unified Parkinson's Disease Rating Scale
timeFrame: Change between baseline (immediately before intervention) and follow-up at 1 week after intervention
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Asociación de Parkinson de Aragón
Study officials:
affiliation: University of Castilla-La Mancha
name: Elisabeth Bravo, Phd
role: STUDY_DIRECTOR
References: