Dry Needling for Spasticity in Stroke

Stroke Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02377804
• Other study ID #: HBMA-URJC
• Status: Completed
• Phase: N/A
• First received: February 27, 2015
• Last updated: April 5, 2015
• Start date: January 2014
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: Universidad Rey Juan Carlos
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Muscle Spasticity
• Stroke

Intervention

Other:
• Dry needling
Patients will receive deep dry needling with disposable stainless steel needles (0.3mm x 50mm) that will be inserted into the skin over taut bands of the spastic musculature of the shoulder area: upper trapezius, subscapularis, infraspinatus, and pect
• Physical Therapy
Patients will receive 3 sessions, one per week, of 45min of physical therapy including mobilizations of the scapular region, manual therapies targeted to decrease muscle tone, neuromodulatory techniques for spasticity and proprioceptive exercises for the upper extremity

Device:
• stainless steel needles (0.3mm x 50mm)

Locations

Country	Name	City	State
Spain	Universidad Rey Juan Carlos	Alcorcón	Madrid
Spain	Hospital Beta María Ana	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Rey Juan Carlos

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in spasticity before and after the intervention	Spasticity in the affected ankle joint will be evaluated with the Modified Modified Ashworth Scale (MMAS). The examiner passively moved the upper extremity in a stretching direction of each muscle (shoulder depression, shoulder external rotation, shoulder internal rotation, and shoulder abduction 90º combined with external rotation, respectively), back and forth at least 5 times and evaluated the degree of resistance to the movement on a scale from 0-4	Baseline and immediate after the interventionBaseline (1 week before) and 1 week after intervention	Yes
Secondary	Changes in pressure pain sensitivity before and after the intervention	Pressure pain thresholds, defined as the amount of pressure applied for the pressure sensation to first change to pain, will be assessed with a mechanical pressure algometer (Pain Diagnosis and Treatment Inc, New York, USA) unilaterally over the affected infraspinatus and deltoid muscles and bilaterally over the C5/C6 zygapophyseal joint.	Baseline (1 week before) and 1 week after intervention	Yes
Secondary	Changes in shoulder mobility before and after the intervention	A universal goniometer will be used to determine the participant's shoulder range of motion in flexion, abduction and external rotation	Baseline (1 week before) and 1 week after intervention	Yes