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CompletedNCT02377804Updated Apr 7, 2015

Dry Needling for Spasticity in Stroke

An interventional study of Dry needling and Physical Therapy in Stroke, sponsored by Universidad Rey Juan Carlos. Completed at 2 sites in Spain. Open to participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-04-07.

Sponsored by Universidad Rey Juan Carlos · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
40 Years to 65 Years
Sex
All
01

Study 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.

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Conditions studied

  • Stroke

Keywords

  • dry needling
  • spasticity
  • pain
03

In context

Muscle Spasticity

704 studies on the registry are indexed under Muscle Spasticity; 149 are open to participants now.

This study's enrollment of 20 is below the median of 36 across 525 interventional studies indexed under Muscle Spasticity.

Browse Muscle Spasticity studies →

Lead sponsor

Universidad Rey Juan Carlos is the lead sponsor of 111 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • 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 · Other: Physical Therapy · 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

Interventions

  • OtherDry 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

  • OtherPhysical 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

  • Devicestainless steel needles (0.3mm x 50mm)
06

What researchers measure

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

    Time frame: Baseline and immediate after the interventionBaseline (1 week before) and 1 week after intervention

Secondary outcomes

  1. 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.

    Time frame: Baseline (1 week before) and 1 week after intervention

  2. 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

    Time frame: Baseline (1 week before) and 1 week after intervention

07

Study locations

2 sites
  • Universidad Rey Juan Carlos
    Alcorcón, Madrid 28922, Spain
  • Hospital Beta María Ana
    Madrid, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02377804
Lead sponsor
Universidad Rey Juan Carlos
Responsible party
César Fernández-de-las-Peñas (Proffesor, Universidad Rey Juan Carlos) — Principal investigator
First posted
Mar 4, 2015
Start date
Jan 2014
Primary completion
Apr 2015
Completion
Apr 2015
Last update
Apr 7, 2015

Study contacts

César Fernández-de-las-Peñas
study director · Universidad Rey Juan Carlos

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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