Effects of Dry Needling on Electromyographic Activity and Ultrasonographic Characteristics in Post-Stroke Spasticity
NCT ID: NCT06017960
Last Updated: 2025-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
28 participants
INTERVENTIONAL
2023-09-15
2026-09-15
Brief Summary
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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).
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Detailed Description
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Secondary, dry needling will also improve the maximum muscle contraction capacity; will improve spastic muscle ultrasound variables in terms of decreased muscle thickness and pennation angle, increased fasciculus length and reduced pixel intensity measured via histogram and second order histogram parameters; as well as dry needling will improve gait parameters such as gait speed, functional gait and better spatiotemporal parameters such as a reduction of the variability, asymmetry and an improve of the stride length.
On the other hand, the investigators hypothesized that there is a correlation between the changes that will be found in the electromyographic activity, the ultrasound variables, and the clinical and gait variables. This information will allow us to make useful predictions of best responders to dry needling according to the information obtained in electromyographic and ultrasound explorations.
The study will be a randomized clinical trial with a control group. Each participant will be randomly assigned to the dry needling group or to the sham dry needling group with a 1:1 ratio, where they will 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.
After being informed about the study, all eligible patients give their written informed consent.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
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
Study Groups
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Dry needling group
Dry needling + usual care. Subjects will receive a total of 4 sessions of ultrasound-guided dry needling over 4 weeks, one per week.
Dry needling + usual care
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.
Control group
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.
Sham dry needling + usual care
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.
Interventions
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Dry needling + usual care
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.
Sham dry needling + usual care
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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University of Alcala
OTHER
Universidad de Zaragoza
OTHER
Responsible Party
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Dr. Pablo Herrero Gallego
PhD
Locations
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Centro Europeo de Neurociencias
Madrid, Madrid, Spain
Countries
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Central Contacts
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Facility Contacts
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Daniel Jiménez Masa
Role: primary
References
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Other Identifiers
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EMGUS-DN
Identifier Type: -
Identifier Source: org_study_id
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