Effects of Dry Needling on Electromyographic Activity and Ultrasonographic Characteristics in Post-Stroke Spasticity

NCT06017960 | Recruiting

• 1 other identifier: EMGUS-DN
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke is a global health problem, with an incidence in Europe of 147/100,000 people per year. It is estimated that 43% of them present spasticity throughout the first year, causing disability, hindering mobility and functionality, which can generate comorbidity problems, which in turn hinders its improvement over time. Recently, high quality studies have conclude that there is a moderate level of evidence with large effect size in reducing spasticity with dry needling, as well as being cost-effective in stroke patients in both the subacute and chronic phases. However, due to the limitation of manual evaluations of spasticity, and it is necessary to look for measurement alternatives that complement it, such as the analysis of the electromyographic activity and the muscular structure measured with ultrasound. These data could provide objective, useful and complementary information to clinical assessments to be more specific and effective in the treatment of stroke patients. This randomized controlled trial aim to analyse the effect of dry needling in this parameters in patients with stroke and spasticity, as well as correlated with gait variables. Each participant will be randomly assigned to the dry needling group or to the sham dry needling group, where participants receive a total of 4 sessions of ultrasound-guided dry needling or sham ultrasound-guided dry needling in the gastrocnemius medialis over 4 weeks, one per week. Measures of spasticity, electromyographic activity and muscle structure via ultrasound will made at baseline (T0) and immediate after each intervention (T1,T2,T3,T4). Gait variables will be made at baseline and after the last intervention (T0 and T4).

Conditions

Spasticity as Sequela of Stroke

Keywords

Dry needling; Spasticity; Hypertonia; Surface electromyography; Diagnostic ultrasound; Gait

Outcome Measures

Primary Outcomes (1)

• Modified Ashworth Scale

  The modified Ashworth scale (MAS) will be the main outcome of the investigation, as is one of the most studied scales in the application of dry needling in patients with spasticity in stroke population. The MAS is indicated to assess spasticity, or positive speed-dependent stretching reflex, in pathologies of the central nervous system. The scale rate muscle tone on a scale between 0 and 4. 0 is no increase in tone, 1 slight increase in tone and catch/release at end of Range Of Motion (ROM), 1+ with catch/release through 1/2 ROM, 2 more marked increased in tone through ROM, but affected part moved easily, 3 considerable increase in tone, passive movement difficult, 4 affected part rigid flexion or extension.

  Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).

Secondary Outcomes (18)

• surface Electromyography (sEMG) - Activity at rest

  Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).

• sEMG - Dynamic stretching

  Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).

• sEMG - Maximum Voluntary Isometric Contraction

  Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).

• Ultrasound (US) - Muscle thickness

  Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).

• US - Pennation angle

  Baseline (T0), after the first intervention in first week (T1), after second intervention in the second week (T2), after third intervention in the third week (T3) and after fourth intervention in fourth week (T4).

Study Arms (2)

Dry needling group

EXPERIMENTAL

Dry needling + usual care. Subjects will receive a total of 4 sessions of ultrasound-guided dry needling over 4 weeks, one per week.

Other: Dry needling + usual care

Control group

SHAM COMPARATOR

Sham or simulated dry needling. + usual care. Subjects will receive a total of 4 sessions of sham ultrasound-guided dry needling over 4 weeks, one per week.

Other: Sham dry needling + usual care

Interventions

Dry needling + usual care OTHER

Participants assigned to the dry needling group will receive a weekly session for four weeks of ultrasound-guided dry needling in the inner gastrocnemius muscle with disposable stainless-steel needles, according to the depth of the muscle to be treated. For the realization of the technique, the diagnostic criteria of the Dry Needling in Hypertonia and Spasticity technique (DNHS®) developed by Herrero et al. will be applied adapted to the characteristics of the study, as well as the procedure for its application. The ultrasound guidance will be the same ultrasound device than in the assessments. This ultrasound-guided intervention allows to guarantee the safety of the approach, to have the certainty in the location of the target structure and to see the responses of local spasm. During the application of the technique, patient will not look at the ultrasound screen to ensure the blindness of the patient to the group allocated.

Dry needling group

Sham dry needling + usual care OTHER

Participants assigned to this group will receive the same assessments, the same number of sessions, and the sham dry needling at the same site as the dry needling group, but with a sham intervention, where the needle is dropped through the guide tube and touch the skin. The patient will not feel anything, or at most that the needle touches the skin, since it does not get into the subcutaneous cell tissue, as placebo interventions were performed in similar studies. The context will be simulated in its entirety, using the same ultrasound and disposable needles for the intervention. Both groups will continue their daily motor rehabilitation treatment during the 4 weeks, which consists of strength training, balance, motor control, gait training, and mass practice oriented to tasks of intensity and duration appropriate to each patient, allowing the fastest possible clinical improvement, as recommended by clinical practice guidelines.

Control group

Eligibility Criteria

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

You may qualify if:

• be over 18 years old
• understand and voluntarily sign informed consent before performing the intervention
• have a medical diagnosis of ischemic or hemorrhagic stroke
• have a grade between 1-3 according to the modified Ashworth scale (MAS) on the triceps sural
• able to walk independently to perform gait test

You may not qualify if:

• recurrent stroke
• who have received previous treatments of botulinum toxin type A in the last 3 months
• who have received treatments with dry needling in the last month
• severe cognitive deficits
• fear of needles
• metal allergy.

Sponsors & Collaborators

• Universidad de Zaragoza: lead
• University of Alcala: collaborator

Study Sites (1)

Centro Europeo de Neurociencias

Madrid, Madrid, 28023, Spain

RECRUITING

Related Publications (28)

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MeSH Terms

Conditions

Muscle Spasticity; Muscle Hypertonia

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Central Study Contacts

Pablo Herrero Gallego, PhD

CONTACT

646168248; pherrero@unizar.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Allocation conceal will be performed using a computer-generated randomized table of numbers created before data collection. Both participants, evaluator and data analyzer will be blinded to the type of intervention. To take the ultrasound images, an artificial arm will be used to hold the probe and to avoid direct contact by the researcher. Another researcher will analyze the images through a program. Both participants, image analyzer and data analyzer will be blinded to the type of intervention
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: August 19, 2023
• First Posted: August 30, 2023
• Study Start: September 15, 2023
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)