Dry Needling for Spasticity in Stroke

NCT ID: NCT02377804

Last Updated: 2015-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-04-30

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental intervention

The experimental intervention will consist of 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. In addition, during this intervention patients will also 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 pectoralis mayor

Group Type: EXPERIMENTAL

Dry needling

Intervention Type: OTHER

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

Intervention Type: OTHER

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

stainless steel needles (0.3mm x 50mm)

Intervention Type: DEVICE

Control intervention

The control intervention will consist of 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.

Group Type: ACTIVE_COMPARATOR

Physical Therapy

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

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

Intervention Type: OTHER

stainless steel needles (0.3mm x 50mm)

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Rey Juan Carlos

OTHER

Sponsor Role: lead

Responsible Party

César Fernández-de-las-Peñas

Proffesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

César Fernández-de-las-Peñas

Role: STUDY_DIRECTOR

Universidad Rey Juan Carlos

Locations

Universidad Rey Juan Carlos

Alcorcón, Madrid, Spain

Hospital Beta María Ana

Madrid, Madrid, Spain

Countries

Spain

Other Identifiers

HBMA-URJC

Identifier Type: -

Identifier Source: org_study_id