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

December 1, 2020 updated by: Rocío Martín Valero, University of Malaga

Efficacy of Dry Needling in the Spasticity of the Hemiparetic Limbs Post-stroke

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Rocío Martín Valero, PhD
  • Phone Number: 34 951 95 28 58
  • Email: rovalemas@uma.es

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Standard physiotherapy rehabilitation and dry needling

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.
Other: Standard physiotherapy rehabilitation and dry needling
The dry needling group receives 6 sessions of dry needling in the spastic muscles of the upper and lower hemiparetic limbs.
Other: Standard physiotherapy rehabilitation
The control group will receive the usual therapy and treatment.
Other: Standard physiotherapy rehabilitation
This group receives their traditional intervention, without dry needling.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in spasticity
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.

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.
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 Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in range of motion
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.

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.
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.
Changes in Motor function of the upper and lower limb
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.

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.
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.
Changes in Gait
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.

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.
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.
Changes in Physical disability
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.

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.
Baseline, 6 weeks of intervention (once a week) and follow-up 1,3,6 and 12 months after the end of the intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Malaga

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rocío Martin Valero, PhD, University of Malaga
  • Study Director: Juan Antonio Armenta Peinado, PhD, University of Malaga

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 15, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 10, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 17, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 3, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UMADryNeed

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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