NCT02291159

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Nov 2014

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 14, 2014

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 31, 2014

Status Verified

December 1, 2014

Enrollment Period

1 month

First QC Date

November 10, 2014

Last Update Submit

December 30, 2014

Conditions

StrokeSpasticity

Keywords

strokespasticitydry needlingupper motor neuron syndromemotor function

Outcome Measures

Primary Outcomes (1)

  • Fugl Meyer Assessment Scale (Motor Function)

    Two weeks

Secondary Outcomes (2)

  • Modified Ashworth Scale (Hypertonia/Spasticity)

    Two weeks

  • Impact Stroke Scale (Quality of Life)

    Two weeks

Study Arms (2)

Intervention-DNHS technique

EXPERIMENTAL

Dry needling of Myofascial Trigger Points

Device: DNHS ® (Dry Needling for Hypertonia and Spasticity)

Control-Sham Dry Needling

SHAM COMPARATOR

Sham Dry Needling of Myofascial Trigger Points

Device: Sham Dry Needling

Interventions

DNHS ® (Dry Needling for Hypertonia and Spasticity)DEVICE

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-DNHS technique
Sham Dry NeedlingDEVICE

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

Control-Sham Dry Needling

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • recurrent stroke episodes
  • other concomitant neurodegenerative conditions
  • fear to needles
  • participation in a parallel study
  • any absolute contraindication for deep dry needling

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Jorge University

Villanueva de Gállego, Zaragoza, 50830, Spain

Location

MeSH Terms

Conditions

StrokeMuscle Spasticity

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Officials

  • Herrero Pablo, Dr.

    San Jorge University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Pablo Herrero Gallego

Study Record Dates

First Submitted

November 10, 2014

First Posted

November 14, 2014

Study Start

November 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

December 31, 2014

Record last verified: 2014-12

Locations

ES(1)