Effectiveness of Dry Needling (DNHS Technique) in the Treatment of Upper Limb Spasticity and Function in Stroke Patients: a Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Fugl Meyer Assessment Scale (Motor Function)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Fugl Meyer Assessment Scale (Motor Function)
Time Frame: Two weeks
Secondary Outcomes
- Modified Ashworth Scale (Hypertonia/Spasticity)(Two weeks)
- Impact Stroke Scale (Quality of Life)(Two weeks)
Investigators
Pablo Herrero Gallego
Dr. Pablo Herrero Gallego
Universidad San Jorge