Back to resultsEffects of DNHS Technique in the Treatment of Upper Limb Spasticity and Function in Stroke
Primary Purpose
Stroke, Spasticity
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
DNHS ® (Dry Needling for Hypertonia and Spasticity)
Sham Dry Needling
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, spasticity, dry needling, upper motor neuron syndrome, motor function
Eligibility 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
Sites / Locations
- San Jorge University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Intervention-DNHS technique
Control-Sham Dry Needling
Arm Description
Dry needling of Myofascial Trigger Points
Sham Dry Needling of Myofascial Trigger Points
Outcomes
Primary Outcome Measures
Fugl Meyer Assessment Scale (Motor Function)
Secondary Outcome Measures
Modified Ashworth Scale (Hypertonia/Spasticity)
Impact Stroke Scale (Quality of Life)
Full Information
NCT ID
NCT02291159
First Posted
November 10, 2014
Last Updated
December 30, 2014
Sponsor
Universidad San Jorge
1. Study Identification
Unique Protocol Identification Number
NCT02291159
Brief Title
Effects of DNHS Technique in the Treatment of Upper Limb Spasticity and Function in Stroke
Official Title
Effectiveness of Dry Needling (DNHS Technique) in the Treatment of Upper Limb Spasticity and Function in Stroke Patients: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad San Jorge
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Spasticity
Keywords
stroke, spasticity, dry needling, upper motor neuron syndrome, motor function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention-DNHS technique
Arm Type
Experimental
Arm Description
Dry needling of Myofascial Trigger Points
Arm Title
Control-Sham Dry Needling
Arm Type
Sham Comparator
Arm Description
Sham Dry Needling of Myofascial Trigger Points
Intervention Type
Device
Intervention Name(s)
DNHS ® (Dry Needling for Hypertonia and Spasticity)
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Sham Dry Needling
Intervention Description
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 Outcome Measure Information:
Title
Fugl Meyer Assessment Scale (Motor Function)
Time Frame
Two weeks
Secondary Outcome Measure Information:
Title
Modified Ashworth Scale (Hypertonia/Spasticity)
Time Frame
Two weeks
Title
Impact Stroke Scale (Quality of Life)
Time Frame
Two weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herrero Pablo, Dr.
Organizational Affiliation
San Jorge University
Official's Role
Study Director
Facility Information:
Facility Name
San Jorge University
City
Villanueva de Gallego
State/Province
Zaragoza
ZIP/Postal Code
50830
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Effects of DNHS Technique in the Treatment of Upper Limb Spasticity and Function in Stroke
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