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Effects of DNHS Technique in the Treatment of Upper Limb Spasticity and Function in Stroke

NCT ID: NCT02291159

Last Updated: 2014-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2014-12-31

Brief Summary

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Introduction: Stroke is a neurological deficit caused by a decrease in cerebral blood flow. The DNHS ® (Dry Needling for hypertonia and Spasticity) technique is a dry needling technique to reduce spasticity and hypertonia and improve function in patients with CNS injury. The main objective of this trial is to analyze the therapeutic effect of DNHS® technique in motor function in patients between 45 and 80 in a chronic state after a stroke. Methods: Double-blinded randomized clinical trial. There will be an intervention group (DNHS® technique) and a sham control group. The intervention will be 2 sessions, one per week, in biceps brachii, brachialis, flexor digitorum superficialis nad profundus, adductor pollicis and first dorsal interossei. The Fugl Meyer Assessment Scale, Modified Ashworth Scale and Stroke Impact Scale will be used as outcome measures. The data will be expressed as mean ± (Standard Deviation). The standardized difference or effect size (ES, 90% confidence limit) in the selected variables will be calculated.

Detailed Description

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Conditions

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Stroke Spasticity

Keywords

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stroke spasticity dry needling upper motor neuron syndrome motor function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Intervention-DNHS technique

Dry needling of Myofascial Trigger Points

Group Type EXPERIMENTAL

DNHS ® (Dry Needling for Hypertonia and Spasticity)

Intervention Type DEVICE

Dry needling of Myofascial Trigger Points. 2 sessions, one per week, in biceps brachii, brachialis, flexor digitorum superficialis nad profundus, adductor pollicis and first dorsal interossei

Control-Sham Dry Needling

Sham Dry Needling of Myofascial Trigger Points

Group Type SHAM_COMPARATOR

Sham Dry Needling

Intervention Type DEVICE

Sham dry needling of Myofascial Trigger Points. 2 sessions, one per week, in biceps brachii, brachialis, flexor digitorum superficialis nad profundus, adductor pollicis and first dorsal interossei

Interventions

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DNHS ® (Dry Needling for Hypertonia and Spasticity)

Dry needling of Myofascial Trigger Points. 2 sessions, one per week, in biceps brachii, brachialis, flexor digitorum superficialis nad profundus, adductor pollicis and first dorsal interossei

Intervention Type DEVICE

Sham Dry Needling

Sham dry needling of Myofascial Trigger Points. 2 sessions, one per week, in biceps brachii, brachialis, flexor digitorum superficialis nad profundus, adductor pollicis and first dorsal interossei

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* people aged 40-85 years with hemiplegia resulting from stroke of more than 6 months evolution (chronic stroke)
* ability to follow instructions and reply to assessment questonnaires

Exclusion Criteria

* recurrent stroke episodes
* other concomitant neurodegenerative conditions
* fear to needles
* participation in a parallel study
* any absolute contraindication for deep dry needling
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad San Jorge

OTHER

Sponsor Role lead

Responsible Party

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Pablo Herrero Gallego

Dr. Pablo Herrero Gallego

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Herrero Pablo, Dr.

Role: STUDY_DIRECTOR

San Jorge University

Locations

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San Jorge University

Villanueva de Gállego, Zaragoza, Spain

Site Status

Countries

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Spain

Other Identifiers

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USJ_DNHS_UL_01

Identifier Type: -

Identifier Source: org_study_id