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

Sponsor

Universidad San Jorge (Other)

Overall Status

Completed

CT.gov ID

NCT02291159

Collaborator

(none)

Enrollment

Location

Arms

Duration (Days)

10.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Spasticity	Device: DNHS ® (Dry Needling for Hypertonia and Spasticity) Device: Sham Dry Needling	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Nov 1, 2014

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Fugl Meyer Assessment Scale (Motor Function) [Two weeks]

Secondary Outcome Measures

Modified Ashworth Scale (Hypertonia/Spasticity) [Two weeks]
Impact Stroke Scale (Quality of Life) [Two weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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