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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02291159
• Other study ID #: USJ_DNHS_UL_01
• Status: Completed
• Phase: N/A
• First received: November 10, 2014
• Last updated: December 30, 2014
• Start date: November 2014
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Universidad San Jorge
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Muscle Spasticity
• Spasticity
• Stroke

Intervention

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 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

Locations

Country	Name	City	State
Spain	San Jorge University	Villanueva de Gallego	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Universidad San Jorge

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl Meyer Assessment Scale (Motor Function)		Two weeks	No
Secondary	Modified Ashworth Scale (Hypertonia/Spasticity)		Two weeks	No
Secondary	Impact Stroke Scale (Quality of Life)		Two weeks	No