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

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.
 
ClinicalTrials.gov Identifier: NCT02291159
Recruitment Status : Completed
First Posted : November 14, 2014
Last Update Posted : December 31, 2014
Sponsor:
Information provided by (Responsible Party):
Pablo Herrero Gallego, Universidad San Jorge

Tracking Information
First Submitted Date  ICMJE November 10, 2014
First Posted Date  ICMJE November 14, 2014
Last Update Posted Date December 31, 2014
Study Start Date  ICMJE November 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2014)
Fugl Meyer Assessment Scale (Motor Function) [ Time Frame: Two weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2014)
  • Modified Ashworth Scale (Hypertonia/Spasticity) [ Time Frame: Two weeks ]
  • Impact Stroke Scale (Quality of Life) [ Time Frame: Two weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of DNHS Technique in the Treatment of Upper Limb Spasticity and Function in Stroke
Official Title  ICMJE Effectiveness of Dry Needling (DNHS Technique) in the Treatment of Upper Limb Spasticity and Function in Stroke Patients: a Randomized Clinical Trial
Brief Summary 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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Stroke
  • Spasticity
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Intervention-DNHS technique
    Dry needling of Myofascial Trigger Points
    Intervention: Device: DNHS ® (Dry Needling for Hypertonia and Spasticity)
  • Sham Comparator: Control-Sham Dry Needling
    Sham Dry Needling of Myofascial Trigger Points
    Intervention: Device: Sham Dry Needling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 13, 2014)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02291159
Other Study ID Numbers  ICMJE USJ_DNHS_UL_01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pablo Herrero Gallego, Universidad San Jorge
Study Sponsor  ICMJE Universidad San Jorge
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Herrero Pablo, Dr. San Jorge University
PRS Account Universidad San Jorge
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP