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

Study Overview
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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.

Official Title
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Effectiveness of Dry Needling (DNHS Technique) in the Treatment of Upper Limb Spasticity and Function in Stroke Patients: a Randomized Clinical Trial

Conditions
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Stroke, Spasticity

Intervention / Treatment
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* Device: DNHS ® (Dry Needling for Hypertonia and Spasticity)
* Device: Sham Dry Needling


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention-DNHS technique<br>Dry needling of Myofascial Trigger Points | Device: DNHS ® (Dry Needling for Hypertonia and Spasticity)<br>* 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<br>|
| Sham Comparator: Control-Sham Dry Needling<br>Sham Dry Needling of Myofascial Trigger Points | Device: Sham Dry Needling<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl Meyer Assessment Scale (Motor Function) |  | Two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Ashworth Scale (Hypertonia/Spasticity) |  | Two weeks | 
| Impact Stroke Scale (Quality of Life) |  | Two weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, spasticity, dry needling, upper motor neuron syndrome, motor function