search
Back to results

Efficacy of Dry Needling in the Spasticity Post-stroke (DNSpasticity)

Primary Purpose

Spasticity, Muscle

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Standard physiotherapy rehabilitation and dry needling
Standard physiotherapy rehabilitation
Sponsored by
University of Malaga
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spasticity, Muscle focused on measuring dry needling, spasticity, hypertonia, stroke

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • First hemiplegic ischemic stroke.
  • Chronic stroke (stroke at least 6 months before the trial).
  • Present a level of spasticity equal or greater than 1 according to the Modified Asworth Scale.
  • Preserve cognitive capacity.
  • Being able to understand and follow simple instructions.
  • Not afraid of needles.

Exclusion Criteria:

  • Recurrent stroke.
  • Subjects with cognitive disorders.
  • Presenting any medical contraindication for the dry needling procedure or problems with coagulation or epilepsy.
  • Alteration of sensitivity.
  • Receives nerve block or botulinum toxin treatments in a period equal or less than 6 months, since ir can modify the results.
  • Hemorrhagic stroke.
  • Subjects who do not consent to participate in the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Standard physiotherapy rehabilitation and dry needling

    Standard physiotherapy rehabilitation

    Arm Description

    In addition to the usual therapy, the experimental group will receive the application of dry needling technique in the hemiparetic limbs. Dry needling intervention will take place over a period of one and a half months (6 weeks), with a total of 6 sessions. Each session will be performed once a week, where a single puncture will be made in each muscle to be treated, using Hong´s technique and lasting 60 seconds per muscle (or until the muscle is release). The muscles that will receive dry needling are the following ones: Upper limb: infraspinatus, teres minor, pectoralis major, deltoid. Lower limb: gastrocnemius, soleus and anterior tibial muscles.

    The control group will receive the usual therapy and treatment.

    Outcomes

    Primary Outcome Measures

    Changes in spasticity
    The spasticity will be measure with the Modified Ashworth Scale. Modified Ashworth Scale is one of the most widely used scales for spasticity measurement. It is an useful, valid and reliable assessment tool that measures the passive movement of a specific joint. It is a valid instrument to represent a quantitative clinical measure of the severity of spasticity in patients with neurological involvement. The scale goes from 0 to 4 points. The higher the score, the greater the impact. Experimental group: Spasticity will be measure before and immediately after the treatment of dry needling in each session (once a week for 6 weeks) and in a follow-up period after finishing treatment (1,3,6 and 12 months after treatment). Control group: Spasticity will be measure at the beginning of the week (before usual therapy) and at the end of the week.

    Secondary Outcome Measures

    Changes in range of motion
    Active and passive range of motion of the shoulder and ankle will be measure with an standard goniometer. Each movement will be evaluated three times, and the average of theses three results will be performed. The same procedure will be followed to measure both active and passive range of motion of each patient. Experimental group: Range of motion will be measure before and immediately after the treatment of dry needling in each session (once a week for 6 weeks) and in a follow-up period after finishing treatment (1,3,6 and 12 months after treatment). Control group: Range of motion will be measure at the beginning of the week (before usual therapy) and at the end of the week.
    Changes in Motor function of the upper and lower limb
    Fugl-Meyer Scale is one of the most complete quantitative measures designed to measure disability after a stroke. It is divided into five domains and each domain has other elements that are evaluated on an ordinal scale of 0 to 2 points. The upper and lower limb motor assessment will be used, with a maximum of 100 points, 66 and 34 respectively, and a minimum of 0 points. The lower the score, the greater the impact. Fugl-Meyer Arm Motor Assessment will be use to evaluate motor function of the upper hemiparetic limb and the Fugl-Meyer Motor Leg Assessment to evaluate motor function of the lower hemiparetic limb. Experimental group: Motor function will be measure before and immediately after the treatment of dry needling in each session (once a week for 6 weeks) and in a follow-up period after finishing treatment (1,3,6 and 12 months after treatment). Control group: Motor function will be measure at the beginning of the week (before usual therapy) and at the end of the week.
    Changes in Gait
    The gait will be measure with the Wisconsin Gait Scale. Gait in hemiparetic patients after a stroke must be safe and efficient. Wisconsin Gait Scale is an instrument used to measure gait problems experienced by patients who have hemiplegia after a stroke. This scale can be used as a tool to determine the effectiveness of rehabilitation training and observe how the patient develops in the different phases of gait. The maximum score is 42 points and the minimum 13.35 points. The higher the score, the greater the patient´s gait involvement. Experimental group: Gait will be measure before and immediately after the treatment of dry needling in each session (once a week for 6 weeks) and in a follow-up period after finishing treatment (1,3,6 and 12 months after treatment). Control group: Gait will be measure at the beginning of the week (before usual therapy) and at the end of the week.
    Changes in Physical disability
    Barthel Index will be used to measure physical disability. It is a widely used instrument to measure the ability of a person to perform daily activities. This tool assesses the independence of the patient to carry out theses activities with or without help. Thanks to this tool, the dependency´s degree can be estimated quantitatively. The maximum score is 100 points and the minimum is 0. The higher the score, the more independence the subject will have. Experimental group: Physical disability will be measure only before the treatment (is the only one that won´t be measure after each session) of dry needling in each session (once a week for 6 weeks) and in a follow-up period after finishing treatment (1,3,6 and 12 months after treatment). Control group: Physical disability will be measure at the beginning of the week (before usual therapy) and at the end of the week.

    Full Information

    First Posted
    June 10, 2020
    Last Updated
    December 1, 2020
    Sponsor
    University of Malaga
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04435561
    Brief Title
    Efficacy of Dry Needling in the Spasticity Post-stroke
    Acronym
    DNSpasticity
    Official Title
    Efficacy of Dry Needling in the Spasticity of the Hemiparetic Limbs Post-stroke
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 15, 2021 (Anticipated)
    Primary Completion Date
    July 15, 2021 (Anticipated)
    Study Completion Date
    September 30, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Malaga

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Stroke is a serious clinical condition and one of the leading causes of long-term disability in the world. One of the most serious complications of this condition is spasticity. Recently, dry needling has commented to be used as a treatment in muscle spasticity of chronic patients after a stroke, producing improvements in clinical conditions. This study evaluates the effectiveness of dry needling technique in the spasticity of the hemiparetic limbs in chronic post-stroke patients. The Modified Ashworth Scale is used to measure the spasticity´s improvement after the procedure.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spasticity, Muscle
    Keywords
    dry needling, spasticity, hypertonia, stroke

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard physiotherapy rehabilitation and dry needling
    Arm Type
    Experimental
    Arm Description
    In addition to the usual therapy, the experimental group will receive the application of dry needling technique in the hemiparetic limbs. Dry needling intervention will take place over a period of one and a half months (6 weeks), with a total of 6 sessions. Each session will be performed once a week, where a single puncture will be made in each muscle to be treated, using Hong´s technique and lasting 60 seconds per muscle (or until the muscle is release). The muscles that will receive dry needling are the following ones: Upper limb: infraspinatus, teres minor, pectoralis major, deltoid. Lower limb: gastrocnemius, soleus and anterior tibial muscles.
    Arm Title
    Standard physiotherapy rehabilitation
    Arm Type
    Other
    Arm Description
    The control group will receive the usual therapy and treatment.
    Intervention Type
    Other
    Intervention Name(s)
    Standard physiotherapy rehabilitation and dry needling
    Intervention Description
    The dry needling group receives 6 sessions of dry needling in the spastic muscles of the upper and lower hemiparetic limbs.
    Intervention Type
    Other
    Intervention Name(s)
    Standard physiotherapy rehabilitation
    Intervention Description
    This group receives their traditional intervention, without dry needling.
    Primary Outcome Measure Information:
    Title
    Changes in spasticity
    Description
    The spasticity will be measure with the Modified Ashworth Scale. Modified Ashworth Scale is one of the most widely used scales for spasticity measurement. It is an useful, valid and reliable assessment tool that measures the passive movement of a specific joint. It is a valid instrument to represent a quantitative clinical measure of the severity of spasticity in patients with neurological involvement. The scale goes from 0 to 4 points. The higher the score, the greater the impact. Experimental group: Spasticity will be measure before and immediately after the treatment of dry needling in each session (once a week for 6 weeks) and in a follow-up period after finishing treatment (1,3,6 and 12 months after treatment). Control group: Spasticity will be measure at the beginning of the week (before usual therapy) and at the end of the week.
    Time Frame
    Baseline, 6 weeks of intervention (before and immediately after the treatment) and follow-up 1,3,6 and 12 months after the end of the intervention.
    Secondary Outcome Measure Information:
    Title
    Changes in range of motion
    Description
    Active and passive range of motion of the shoulder and ankle will be measure with an standard goniometer. Each movement will be evaluated three times, and the average of theses three results will be performed. The same procedure will be followed to measure both active and passive range of motion of each patient. Experimental group: Range of motion will be measure before and immediately after the treatment of dry needling in each session (once a week for 6 weeks) and in a follow-up period after finishing treatment (1,3,6 and 12 months after treatment). Control group: Range of motion will be measure at the beginning of the week (before usual therapy) and at the end of the week.
    Time Frame
    Baseline, 6 weeks of intervention (before and immediately after the treatment) and follow-up 1,3,6 and 12 months after the end of the intervention.
    Title
    Changes in Motor function of the upper and lower limb
    Description
    Fugl-Meyer Scale is one of the most complete quantitative measures designed to measure disability after a stroke. It is divided into five domains and each domain has other elements that are evaluated on an ordinal scale of 0 to 2 points. The upper and lower limb motor assessment will be used, with a maximum of 100 points, 66 and 34 respectively, and a minimum of 0 points. The lower the score, the greater the impact. Fugl-Meyer Arm Motor Assessment will be use to evaluate motor function of the upper hemiparetic limb and the Fugl-Meyer Motor Leg Assessment to evaluate motor function of the lower hemiparetic limb. Experimental group: Motor function will be measure before and immediately after the treatment of dry needling in each session (once a week for 6 weeks) and in a follow-up period after finishing treatment (1,3,6 and 12 months after treatment). Control group: Motor function will be measure at the beginning of the week (before usual therapy) and at the end of the week.
    Time Frame
    Baseline, 6 weeks of intervention (before and immediately after the treatment) and follow-up 1,3,6 and 12 months after the end of the intervention.
    Title
    Changes in Gait
    Description
    The gait will be measure with the Wisconsin Gait Scale. Gait in hemiparetic patients after a stroke must be safe and efficient. Wisconsin Gait Scale is an instrument used to measure gait problems experienced by patients who have hemiplegia after a stroke. This scale can be used as a tool to determine the effectiveness of rehabilitation training and observe how the patient develops in the different phases of gait. The maximum score is 42 points and the minimum 13.35 points. The higher the score, the greater the patient´s gait involvement. Experimental group: Gait will be measure before and immediately after the treatment of dry needling in each session (once a week for 6 weeks) and in a follow-up period after finishing treatment (1,3,6 and 12 months after treatment). Control group: Gait will be measure at the beginning of the week (before usual therapy) and at the end of the week.
    Time Frame
    Baseline, 6 weeks of intervention (before and immediately after the treatment) and follow-up 1,3,6 and 12 months after the end of the intervention.
    Title
    Changes in Physical disability
    Description
    Barthel Index will be used to measure physical disability. It is a widely used instrument to measure the ability of a person to perform daily activities. This tool assesses the independence of the patient to carry out theses activities with or without help. Thanks to this tool, the dependency´s degree can be estimated quantitatively. The maximum score is 100 points and the minimum is 0. The higher the score, the more independence the subject will have. Experimental group: Physical disability will be measure only before the treatment (is the only one that won´t be measure after each session) of dry needling in each session (once a week for 6 weeks) and in a follow-up period after finishing treatment (1,3,6 and 12 months after treatment). Control group: Physical disability will be measure at the beginning of the week (before usual therapy) and at the end of the week.
    Time Frame
    Baseline, 6 weeks of intervention (once a week) and follow-up 1,3,6 and 12 months after the end of the intervention.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: First hemiplegic ischemic stroke. Chronic stroke (stroke at least 6 months before the trial). Present a level of spasticity equal or greater than 1 according to the Modified Asworth Scale. Preserve cognitive capacity. Being able to understand and follow simple instructions. Not afraid of needles. Exclusion Criteria: Recurrent stroke. Subjects with cognitive disorders. Presenting any medical contraindication for the dry needling procedure or problems with coagulation or epilepsy. Alteration of sensitivity. Receives nerve block or botulinum toxin treatments in a period equal or less than 6 months, since ir can modify the results. Hemorrhagic stroke. Subjects who do not consent to participate in the study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rocío Martín Valero, PhD
    Phone
    34 951 95 28 58
    Email
    rovalemas@uma.es
    First Name & Middle Initial & Last Name or Official Title & Degree
    Angela Ramos Villodres
    Email
    angeramosvillodres@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rocío Martin Valero, PhD
    Organizational Affiliation
    University of Malaga
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Juan Antonio Armenta Peinado, PhD
    Organizational Affiliation
    University of Malaga
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Efficacy of Dry Needling in the Spasticity Post-stroke

    We'll reach out to this number within 24 hrs