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Clinical Trials/NCT03906305
NCT03906305
Completed
Not Applicable

Changes in Clinical Outcomes After Application of Physical Therapy and Dry Needling Intervention in Stroke Patients

Universidad Rey Juan Carlos1 site in 1 country18 target enrollmentNovember 26, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ischemic Stroke
Sponsor
Universidad Rey Juan Carlos
Enrollment
18
Locations
1
Primary Endpoint
Changes in spasticity before and after the intervention
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The investigators aim to determine if dry needling technique in a non myofascial trigger point area generate the same changes in spasticity, function and pain responses as with dry needling in a myofascial trigger point area.

Detailed Description

Spasticity is a consequence of multiple diseases that affect the Central Nervous System, such as stroke and other neurodegenerative diseases. Its pathophysiology is unclear and the variety of clinical symptoms is determined by the injury location. Several studies have suggested the possibility of active pain treatment effectiveness through myofascial trigger points management. One of these interventions is dry needling, which has been used in several scientific studies. However, these investigations have been based on spasm response or deep dry needling mechanisms always over a trigger point, but none of the participants compare the possible mechanical effects of the insertion of a needle into a spastic muscle without targeting specifically a trigger point. Therefore, the aim of this study is to evaluate the effects on spasticity, pain and motor function after a dry needling intervention versus the insertion of a needle into a non trigger point area in patients who had experienced a stroke.

Registry
clinicaltrials.gov
Start Date
November 26, 2018
End Date
November 6, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Alma Rocío Hernández Ortíz

Principal Investigator

Universidad Rey Juan Carlos

Eligibility Criteria

Inclusion Criteria

  • Medical diagnosis of unilateral ischemic Stroke
  • Unilateral hemiplegia resulting from Stroke
  • Evolution of at least 6 months since the Stroke
  • Age between 35 and 81 years of age
  • Presence of hypertonia in the upper extremity
  • Restricted shoulder range of motion

Exclusion Criteria

  • Recurrent Stroke
  • Previous treatment with nerve blocks, motor point injections with neurolytic agents for Spasticity at any time, or with BTX-A in the previous 6 months
  • Cognitive deficits
  • Progressive or severe neurological diseases, eg, heart conditions, unstable hypertension, fractures or implants in upper extremity
  • Belonephobia (fear to needles)
  • Have received pharmacological treatment for shoulder pain 3 months before the study
  • Existence of peripheral nerve injury
  • Previous history of fracture in the gleno-humeral joint
  • Episodes of epilepsy in the year prior to participation in the study

Outcomes

Primary Outcomes

Changes in spasticity before and after the intervention

Time Frame: Baseline, 1, 2, 3, 4, 5, and 6 weeks after each intervention

It will be measured using the Modified Ashworth Scale. The Modified Ashworth Scale evaluates the muscle tone in patients with central nervous system lesions. It consists of 5 ordinal categories: 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion), 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder less than half of the range of motion), 2 (more marked increase in muscle tone through most of the range of motion, but affected parts easily moved), 3 (considerable increase in muscle tone, passive movement difficult) and 4 (the part affects this rigid extension or flexion).

Secondary Outcomes

  • Changes in shoulder pain before and after the intervention(Baseline, 1, 2, 3, 4, 5, and 6 weeks after each intervention)
  • Changes in Function of the Upper Extremity before and after the intervention(Baseline, 1, 2, 3, 4, 5, and 6 weeks after each intervention)

Study Sites (1)

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