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

December 30, 2014 updated by: Pablo Herrero Gallego, Universidad San Jorge

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Zaragoza
      • Villanueva de Gallego, Zaragoza, Spain, 50830
        • San Jorge University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fugl Meyer Assessment Scale (Motor Function)
Time Frame: Two weeks
Two weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad San Jorge

Investigators

  • Study Director: Herrero Pablo, Dr., San Jorge University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

November 10, 2014

First Submitted That Met QC Criteria

November 13, 2014

First Posted (Estimate)

November 14, 2014

Study Record Updates

Last Update Posted (Estimate)

December 31, 2014

Last Update Submitted That Met QC Criteria

December 30, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USJ_DNHS_UL_01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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