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

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: Unknown
• Conditions: Spasticity, Muscle
• Intervention / Treatment: Other: Standard physiotherapy rehabilitation and dry needling; Other: Standard physiotherapy rehabilitation

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: University of Malaga
• Investigators: Principal Investigator: Rocío Martin Valero, PhD, University of Malaga; Study Director: Juan Antonio Armenta Peinado, PhD, University of Malaga

Study record dates

Study Major Dates

• Study Start (Anticipated): January 15, 2021
• Primary Completion (Anticipated): July 15, 2021
• Study Completion (Anticipated): September 30, 2021

Study Registration Dates

• First Submitted: June 10, 2020
• First Submitted That Met QC Criteria: June 14, 2020
• First Posted (Actual): June 17, 2020

Study Record Updates

• Last Update Posted (Actual): December 3, 2020
• Last Update Submitted That Met QC Criteria: December 1, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: stroke; spasticity; dry needling; hypertonia
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Muscle Spasticity
• Other Study ID 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