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Dry Needling for Spasticity in Stroke

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ClinicalTrials.gov Identifier: NCT02377804
Recruitment Status : Completed
First Posted : March 4, 2015
Last Update Posted : April 7, 2015
Sponsor:
Information provided by (Responsible Party):
César Fernández-de-las-Peñas, Universidad Rey Juan Carlos

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.

Condition or disease Intervention/treatment Phase
Stroke Other: Dry needling Other: Physical Therapy Device: stainless steel needles (0.3mm x 50mm) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : January 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Arm Intervention/treatment
Experimental: 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
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

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

Device: stainless steel needles (0.3mm x 50mm)
Active Comparator: 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.
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




Primary Outcome Measures :
  1. Changes in spasticity before and after the intervention [ Time Frame: Baseline and immediate after the interventionBaseline (1 week before) and 1 week after 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


Secondary Outcome Measures :
  1. Changes in pressure pain sensitivity before and after the intervention [ Time Frame: Baseline (1 week before) and 1 week after 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.

  2. Changes in shoulder mobility before and after the intervention [ Time Frame: Baseline (1 week before) and 1 week after intervention ]
    A universal goniometer will be used to determine the participant's shoulder range of motion in flexion, abduction and external rotation



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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02377804


Locations
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Spain
Universidad Rey Juan Carlos
Alcorcón, Madrid, Spain, 28922
Hospital Beta María Ana
Madrid, Spain
Sponsors and Collaborators
Universidad Rey Juan Carlos
Investigators
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Study Director: César Fernández-de-las-Peñas Universidad Rey Juan Carlos
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Responsible Party: César Fernández-de-las-Peñas, Proffesor, Universidad Rey Juan Carlos
ClinicalTrials.gov Identifier: NCT02377804    
Other Study ID Numbers: HBMA-URJC
First Posted: March 4, 2015    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: April 2015
Keywords provided by César Fernández-de-las-Peñas, Universidad Rey Juan Carlos:
dry needling
spasticity
pain
Additional relevant MeSH terms:
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Muscle Spasticity
Stroke
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