Clinical trial NCT02377804: Dry Needling for Spasticity in Stroke
Official title: Changes in Spasticity, Range of Motion and Pressure Pain Sensitivity in Patients With Stroke After the Application of Dry Needling in the Shoulder Musculature
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: dry needling
spasticity
pain
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2015-03-04
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Stroke is the leading cause of physical disability due to the presence of spasticity. Different needling techniques, including Botulinum Toxin A are proposed for management of spasticity; however results are conflicting. The presence of spasticity in the upper extremity implies several impairments for daily life activities. No study has investigated the effects of deep dry needling inserted into the targeted spastic musculature of the shoulder region in patients who had suffered a stroke. The investigators will conduct a randomized controlled trial investigating the effects of the inclusion of deep dry needling into a rehabilitation program over the musculature of the shoulder region, pressure pain hyperalgesia and range of motion in individuals with chronic stroke. The investigators hypothesize that patients receiving dry needling into the spastic shoulder musculature would exhibit greater improvements in spasticity, pressure sensitivity and range of motion than those who will not receive the intervention.


Eligibility criteria: Inclusion Criteria:

* first-ever unilateral stroke;
* hemiplegia resulting from stroke;
* age between 40 and 65 years old;
* presence of hypertonicity in the upper extremity;
* restricted range of motion of the shoulder

Exclusion Criteria:

* recurrent stroke;
* previous treatment with nerve blocks, motor point injections with neurolytic agents for spasticity at any time;
* previous treatment with BTX-A in the 6 months prior the study;
* severe cognitive deficits; 5, progressive or severe neurologic diseases, e.g., heart conditions, unstable hypertension, fracture or implants in the lower extremity;
* fear to needles;
* any contraindication for deep dry needling, e.g., anticoagulants, infections, bleeding, or psychotic.

Primary outcomes:
measure: Changes in spasticity before and after the intervention
timeFrame: Baseline and immediate after the interventionBaseline (1 week before) and 1 week after intervention
Secondary outcomes:
measure: Changes in pressure pain sensitivity before and after the intervention
timeFrame: Baseline (1 week before) and 1 week after intervention
measure: Changes in shoulder mobility before and after the intervention
timeFrame: Baseline (1 week before) and 1 week after intervention
Other outcomes:
Locations:
city: Alcorcón
country: Spain
facility: Universidad Rey Juan Carlos
state: Madrid
city: Madrid
country: Spain
facility: Hospital Beta María Ana
Study officials:
affiliation: Universidad Rey Juan Carlos
name: César Fernández-de-las-Peñas
role: STUDY_DIRECTOR
References: