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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02291159
First Posted: November 14, 2014
Last Update Posted: December 31, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pablo Herrero Gallego, Universidad San Jorge
  Purpose
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.

Condition Intervention
Stroke Spasticity Device: DNHS ® (Dry Needling for Hypertonia and Spasticity) Device: Sham Dry Needling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Dry Needling (DNHS Technique) in the Treatment of Upper Limb Spasticity and Function in Stroke Patients: a Randomized Clinical Trial

Further study details as provided by Pablo Herrero Gallego, Universidad San Jorge:

Primary Outcome Measures:
  • Fugl Meyer Assessment Scale (Motor Function) [ Time Frame: Two weeks ]

Secondary Outcome Measures:
  • Modified Ashworth Scale (Hypertonia/Spasticity) [ Time Frame: Two weeks ]
  • Impact Stroke Scale (Quality of Life) [ Time Frame: Two weeks ]

Enrollment: 10
Study Start Date: November 2014
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention-DNHS technique
Dry needling of Myofascial Trigger Points
Device: 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
Sham Comparator: Control-Sham Dry Needling
Sham Dry Needling of Myofascial Trigger Points
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02291159


Locations
Spain
San Jorge University
Villanueva de Gallego, Zaragoza, Spain, 50830
Sponsors and Collaborators
Universidad San Jorge
Investigators
Study Director: Herrero Pablo, Dr. San Jorge University
  More Information

Responsible Party: Pablo Herrero Gallego, Dr. Pablo Herrero Gallego, Universidad San Jorge
ClinicalTrials.gov Identifier: NCT02291159     History of Changes
Other Study ID Numbers: USJ_DNHS_UL_01
First Submitted: November 10, 2014
First Posted: November 14, 2014
Last Update Posted: December 31, 2014
Last Verified: December 2014

Keywords provided by Pablo Herrero Gallego, Universidad San Jorge:
stroke
spasticity
dry needling
upper motor neuron syndrome
motor function

Additional relevant MeSH terms:
Stroke
Muscle Spasticity
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms