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NCT Number: NCT02291159

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spasticity Vascular Diseases

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Jorge University

Villanueva de Gállego, Zaragoza, 50830, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DNHS ® (Dry Needling for Hypertonia and Spasticity)

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

Sham Dry needling

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

Primary outcomes

  1. Fugl Meyer Assessment Scale (Motor Function)

    Time frame: Two weeks

Secondary outcomes

  1. Modified Ashworth Scale (Hypertonia/Spasticity)

    Time frame: Two weeks

  2. Impact Stroke Scale (Quality of Life)

    Time frame: Two weeks

Sponsors and collaborators

Lead sponsor

Universidad San Jorge

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Nov 14, 2014
Registry last updated
Dec 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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