Efficacy of Dry Needling in the Spasticity Post-stroke

Spasticity, Muscle Clinical Trial

— DNSpasticity  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04435561
• Other study ID #: UMADryNeed
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 15, 2021
• Est. completion date: September 30, 2021

Study information

• Verified date: December 2020
• Source: University of Malaga
• Contact: Rocío Martín Valero, PhD
• Phone: 34 951 95 28 58
• Email: rovalemas[@]uma.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: September 30, 2021
• Est. primary completion date: July 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Muscle Spasticity
• Spasticity, Muscle

Intervention

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.
• Standard physiotherapy rehabilitation
This group receives their traditional intervention, without dry needling.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaga

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	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.	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	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.	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	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.	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	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.	Baseline, 6 weeks of intervention (once a week) and follow-up 1,3,6 and 12 months after the end of the intervention.