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Clinical Trials/NCT02377804
NCT02377804
Completed
N/A

Changes in Spasticity, Range of Motion and Pressure Pain Sensitivity in Patients With Stroke After the Application of Dry Needling in the Shoulder Musculature

Universidad Rey Juan Carlos2 sites in 1 country20 target enrollmentJanuary 2014
ConditionsStroke

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
Universidad Rey Juan Carlos
Enrollment
20
Locations
2
Primary Endpoint
Changes in spasticity before and after the intervention
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2014
End Date
April 2015
Last Updated
11 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

César Fernández-de-las-Peñas

Proffesor

Universidad Rey Juan Carlos

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.

Outcomes

Primary Outcomes

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 Outcomes

  • Changes in shoulder mobility before and after the intervention(Baseline (1 week before) and 1 week after intervention)
  • Changes in pressure pain sensitivity before and after the intervention(Baseline (1 week before) and 1 week after intervention)

Study Sites (2)

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