Dry Needling for Spasticity in Stroke

NCT02377804 | Completed DMC

• 1 other identifier: HBMA-URJC
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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

Keywords

dry needling; spasticity; pain

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Changes in pressure pain sensitivity before and after the intervention

  Baseline (1 week before) and 1 week after intervention

• Changes in shoulder mobility before and after the intervention

  Baseline (1 week before) and 1 week after intervention

Study Arms (2)

Experimental intervention

EXPERIMENTAL

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

Other: Dry needling; Other: Physical Therapy; Device: stainless steel needles (0.3mm x 50mm)

Control intervention

ACTIVE COMPARATOR

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.

Other: Physical Therapy

Interventions

Dry needling 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

Experimental intervention

Physical Therapy 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

Control intervention; Experimental intervention

stainless steel needles (0.3mm x 50mm) DEVICE

Experimental intervention

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead

Study Sites (2)

Universidad Rey Juan Carlos

Alcorcón, Madrid, 28922, Spain

Location

Hospital Beta María Ana

Madrid, Madrid, Spain

Location

MeSH Terms

Conditions

Stroke; Muscle Spasticity; Pain

Interventions

Dry Needling; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Rehabilitation

Study Officials

• César Fernández-de-las-Peñas

  Universidad Rey Juan Carlos

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffesor

Study Record Dates

• First Submitted: February 27, 2015
• First Posted: March 4, 2015
• Study Start: January 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: April 7, 2015

Record last verified: 2015-04

Locations

ES (2)