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

Overview

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).

Detailed description

The aim of the study is to analyse the effect of dry needling in stroke patients. The investigators hypothesized dry needling will decrease spasticity and electromyographic activity of spastic muscles during dynamic stretching and at rest, causing a reduction of their abnormal hyperactivity.

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.

Interventions

• Other 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
• Other 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 i

Primary outcome measures

• Modified Ashworth Scale [Time frame: 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 outcome measures (12)

• surface Electromyography (sEMG) - Activity at rest [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 - Fascicle length [Time frame: 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 - Histogram/Echo intensity [Time frame: 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 - Grey level co-occurrence matrices (GLCM) [Time frame: 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 - Run-length matrices (GLRLM) [Time frame: 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 - Local binary pattern (LBP) [Time frame: 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 - Blob analysis (BA) [Time frame: 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).]
• Timed Up and Go (TUG) [Time frame: Baseline (T0) and after the fourth intervention in fourth week (T4).]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Spain · 1 center

• Centro Europeo de Neurociencias — Madrid

Publications

• Diaz-Guzman J, Egido JA, Gabriel-Sanchez R, Barbera-Comes G, Fuentes-Gimeno B, Fernandez-Perez C; IBERICTUS Study Investigators of the Stroke Project of the Spanish Cerebrovascular Diseases Study Group. Stroke and transient ischemic attack incidence rate in Spain: the IBERICTUS study. Cerebrovasc Dis. 2012;34(4):272-81. doi: 10.1159/000342652. Epub 2012 Oct 20. PMID 23095851
• Dornak T, Justanova M, Konvalinkova R, Riha M, Muzik J, Hoskovcova M, Srp M, Navratilova D, Otruba P, Gal O, Svobodova I, Dusek L, Bares M, Kanovsky P, Jech R. Prevalence and evolution of spasticity in patients suffering from first-ever stroke with carotid origin: a prospective, longitudinal study. Eur J Neurol. 2019 Jun;26(6):880-886. doi: 10.1111/ene.13902. Epub 2019 Feb 8. PMID 30623522
• Sommerfeld DK, Eek EU, Svensson AK, Holmqvist LW, von Arbin MH. Spasticity after stroke: its occurrence and association with motor impairments and activity limitations. Stroke. 2004 Jan;35(1):134-9. doi: 10.1161/01.STR.0000105386.05173.5E. Epub 2003 Dec 18. PMID 14684785
• Simic-Panic D, Boskovic K, Milicevic M, Rabi Zikic T, Cvjetkovic Bosnjak M, Tomasevic-Todorovic S, Jovicevic M. The Impact of Comorbidity on Rehabilitation Outcome after Ischemic Stroke. Acta Clin Croat. 2018 Mar;57(1):5-15. doi: 10.20471/acc.2018.57.01.01. PMID 30256006
• Kabboord AD, Van Eijk M, Buijck BI, Koopmans RTCM, van Balen R, Achterberg WP. Comorbidity and intercurrent diseases in geriatric stroke rehabilitation: a multicentre observational study in skilled nursing facilities. Eur Geriatr Med. 2018;9(3):347-353. doi: 10.1007/s41999-018-0043-5. Epub 2018 Mar 13. PMID 29887923
• Li S, Francisco GE, Rymer WZ. A New Definition of Poststroke Spasticity and the Interference of Spasticity With Motor Recovery From Acute to Chronic Stages. Neurorehabil Neural Repair. 2021 Jul;35(7):601-610. doi: 10.1177/15459683211011214. Epub 2021 May 12. PMID 33978513
• Puce L, Curra A, Marinelli L, Mori L, Capello E, Di Giovanni R, Bodrero M, Solaro C, Cotellessa F, Fattapposta F, Trompetto C. Spasticity, spastic dystonia, and static stretch reflex in hypertonic muscles of patients with multiple sclerosis. Clin Neurophysiol Pract. 2021 Jun 16;6:194-202. doi: 10.1016/j.cnp.2021.05.002. eCollection 2021. PMID 34278056
• Marinelli L, Trompetto C, Mori L, Vigo G, Traverso E, Colombano F, Abbruzzese G. Manual linear movements to assess spasticity in a clinical setting. PLoS One. 2013;8(1):e53627. doi: 10.1371/journal.pone.0053627. Epub 2013 Jan 15. PMID 23335966

Identifiers

NCT: NCT06017960 · EMGUS-DN

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗