Efficacy of Dry Needling in the Spasticity Post-stroke

NCT04435561 | Unknown DMC

• 1 other identifier: UMADryNeed
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Spasticity, Muscle

Keywords

dry needling; spasticity; hypertonia; stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Changes in range of motion

  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

  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

  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

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

Study Arms (2)

Standard physiotherapy rehabilitation and dry needling

EXPERIMENTAL

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

Standard physiotherapy rehabilitation

OTHER

The control group will receive the usual therapy and treatment.

Other: Standard physiotherapy rehabilitation

Interventions

Standard physiotherapy rehabilitation and dry needling OTHER

The dry needling group receives 6 sessions of dry needling in the spastic muscles of the upper and lower hemiparetic limbs.

Standard physiotherapy rehabilitation and dry needling

Standard physiotherapy rehabilitation OTHER

This group receives their traditional intervention, without dry needling.

Standard physiotherapy rehabilitation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaga: lead

MeSH Terms

Conditions

Muscle Spasticity; Muscle Hypertonia; Stroke

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Officials

• Rocío Martin Valero, PhD

  University of Malaga

  PRINCIPAL INVESTIGATOR

• Juan Antonio Armenta Peinado, PhD

  University of Malaga

  STUDY DIRECTOR

Central Study Contacts

Rocío Martín Valero, PhD

CONTACT

34 951 95 28 58; rovalemas@uma.es

Angela Ramos Villodres

CONTACT

angeramosvillodres@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 17, 2020
• Study Start: January 15, 2021
• Primary Completion: July 15, 2021
• Study Completion: September 30, 2021
• Last Updated: December 3, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share