Clinical trial NCT06017960: Effects of Dry Needling on Electromyographic Activity and Ultrasonographic Characteristics in Post-Stroke Spasticity
Official title: Effects of Dry Needling on Electromyographic Activity and Ultrasonographic Characteristics in Post-Stroke Spasticity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spasticity as Sequela of Stroke
Keywords: Dry needling
Spasticity
Hypertonia
Surface electromyography
Diagnostic ultrasound
Gait
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
Collaborators: name: University of Alcala
First posted: 2023-08-30
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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).

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.

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.

Primary outcomes:
measure: Modified Ashworth Scale
timeFrame: 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:
measure: surface Electromyography (sEMG) - Activity at rest
timeFrame: 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).
measure: sEMG - Dynamic stretching
timeFrame: 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).
measure: sEMG - Maximum Voluntary Isometric Contraction
timeFrame: 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).
measure: Ultrasound (US) - Muscle thickness
timeFrame: 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).
measure: US - Pennation angle
timeFrame: 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).
measure: US - Fascicle length
timeFrame: 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).
measure: US - Histogram/Echo intensity
timeFrame: 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).
measure: US - Grey level co-occurrence matrices (GLCM)
timeFrame: 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).
measure: US - Run-length matrices (GLRLM)
timeFrame: 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).
measure: US - Local binary pattern (LBP)
timeFrame: 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).
measure: US - Blob analysis (BA)
timeFrame: 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).
measure: Timed Up and Go (TUG)
timeFrame: Baseline (T0) and after the fourth intervention in fourth week (T4).
measure: 10 Meter Walking Test (10MWT)
timeFrame: Baseline (T0) and after the fourth intervention in fourth week (T4).
measure: 6 Minute Walking Test (6MWT)
timeFrame: Baseline (T0) and after the fourth intervention in fourth week (T4).
measure: Gait variability
timeFrame: Baseline (T0) and after the fourth intervention in fourth week (T4).
measure: Gait asymmetry
timeFrame: Baseline (T0) and after the fourth intervention in fourth week (T4).
measure: Affected leg stride length
timeFrame: Baseline (T0) and after the fourth intervention in fourth week (T4).
measure: Non-affected leg stride length
timeFrame: Baseline (T0) and after the fourth intervention in fourth week (T4).
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Centro Europeo de Neurociencias
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Bynum R, Garcia O, Herbst E, Kossa M, Liou K, Cowan A, Hilton C. Effects of Dry Needling on Spasticity and Range of Motion: A Systematic Review. Am J Occup Ther. 2021 Jan-Feb;75(1):7501205030p1-7501205030p13. doi: 10.5014/ajot.2021.041798.
citation: Fernandez Sanchis D, Cuenca Zaldivar JN, Calvo S, Herrero P, Gomez Barrera M. Cost-effectiveness of upper extremity dry needling in the rehabilitation of patients with stroke. Acupunct Med. 2022 Apr;40(2):160-168. doi: 10.1177/09645284211055750. Epub 2021 Dec 2.
citation: Fernandez-Sanchis D, Brandin-de la Cruz N, Jimenez-Sanchez C, Gil-Calvo M, Herrero P, Calvo S. Cost-Effectiveness of Upper Extremity Dry Needling in Chronic Stroke. Healthcare (Basel). 2022 Jan 14;10(1):160. doi: 10.3390/healthcare10010160.
citation: Yu B, Zhang X, Cheng Y, Liu L, YanJiang, Wang J, Lu X. The Effects of the Biceps Brachii and Brachioradialis on Elbow Flexor Muscle Strength and Spasticity in Stroke Patients. Neural Plast. 2022 Mar 2;2022:1295908. doi: 10.1155/2022/1295908. eCollection 2022.
citation: Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.
citation: Campanella W, Corazza A, Puce L, Privitera L, Pedrini R, Mori L, Boccuni L, Turtulici G, Trompetto C, Marinelli L. Shear wave elastography combined with electromyography to assess the effect of botulinum toxin on spastic dystonia following stroke: A pilot study. Front Neurol. 2022 Oct 10;13:980746. doi: 10.3389/fneur.2022.980746. eCollection 2022.
citation: Collen FM, Wade DT, Bradshaw CM. Mobility after stroke: reliability of measures of impairment and disability. Int Disabil Stud. 1990 Jan-Mar;12(1):6-9. doi: 10.3109/03790799009166594.
citation: Kosak M, Smith T. Comparison of the 2-, 6-, and 12-minute walk tests in patients with stroke. J Rehabil Res Dev. 2005 Jan-Feb;42(1):103-7. doi: 10.1682/jrrd.2003.11.0171.
citation: Calvo S, Brandin-de la Cruz N, Jimenez-Sanchez C, Bravo-Esteban E, Herrero P. Effects of dry needling on function, hypertonia and quality of life in chronic stroke: a randomized clinical trial. Acupunct Med. 2022 Aug;40(4):312-321. doi: 10.1177/09645284211056347. Epub 2021 Dec 13.
citation: Hornby TG, Reisman DS, Ward IG, Scheets PL, Miller A, Haddad D, Fox EJ, Fritz NE, Hawkins K, Henderson CE, Hendron KL, Holleran CL, Lynskey JE, Walter A; and the Locomotor CPG Appraisal Team. Clinical Practice Guideline to Improve Locomotor Function Following Chronic Stroke, Incomplete Spinal Cord Injury, and Brain Injury. J Neurol Phys Ther. 2020 Jan;44(1):49-100. doi: 10.1097/NPT.0000000000000303.
citation: Fernandez-de-Las-Penas C, Perez-Bellmunt A, Llurda-Almuzara L, Plaza-Manzano G, De-la-Llave-Rincon AI, Navarro-Santana MJ. Is Dry Needling Effective for the Management of Spasticity, Pain, and Motor Function in Post-Stroke Patients? A Systematic Review and Meta-Analysis. Pain Med. 2021 Feb 4;22(1):131-141. doi: 10.1093/pm/pnaa392.
citation: Valencia-Chulian R, Heredia-Rizo AM, Moral-Munoz JA, Lucena-Anton D, Luque-Moreno C. Dry needling for the management of spasticity, pain, and range of movement in adults after stroke: A systematic review. Complement Ther Med. 2020 Aug;52:102515. doi: 10.1016/j.ctim.2020.102515. Epub 2020 Jul 16.
citation: Ansari NN, Naghdi S, Arab TK, Jalaie S. The interrater and intrarater reliability of the Modified Ashworth Scale in the assessment of muscle spasticity: limb and muscle group effect. NeuroRehabilitation. 2008;23(3):231-7.
citation: Perkisas S, Baudry S, Bauer J, Beckwee D, De Cock AM, Hobbelen H, Jager-Wittenaar H, Kasiukiewicz A, Landi F, Marco E, Merello A, Piotrowicz K, Sanchez E, Sanchez-Rodriguez D, Scafoglieri A, Cruz-Jentoft A, Vandewoude M. Application of ultrasound for muscle assessment in sarcopenia: towards standardized measurements. Eur Geriatr Med. 2018 Dec;9(6):739-757. doi: 10.1007/s41999-018-0104-9. Epub 2018 Sep 17.
citation: Miller T, Ying MTC, Chung RCK, Pang MYC. Convergent Validity and Test-Retest Reliability of Multimodal Ultrasonography and Related Clinical Measures in People With Chronic Stroke. Arch Phys Med Rehabil. 2022 Mar;103(3):459-472.e4. doi: 10.1016/j.apmr.2021.09.015. Epub 2021 Oct 23.
citation: Aggeloussis N, Giannakou E, Albracht K, Arampatzis A. Reproducibility of fascicle length and pennation angle of gastrocnemius medialis in human gait in vivo. Gait Posture. 2010 Jan;31(1):73-7. doi: 10.1016/j.gaitpost.2009.08.249. Epub 2009 Sep 22.
citation: Nielsen PK, Jensen BR, Darvann T, Jorgensen K, Bakke M. Quantitative ultrasound image analysis of the supraspinatus muscle. Clin Biomech (Bristol). 2000;15 Suppl 1:S13-6. doi: 10.1016/s0268-0033(00)00053-x.
citation: Hafsteinsdottir TB, Rensink M, Schuurmans M. Clinimetric properties of the Timed Up and Go Test for patients with stroke: a systematic review. Top Stroke Rehabil. 2014 May-Jun;21(3):197-210. doi: 10.1310/tsr2103-197.
citation: Lefeber N, Degelaen M, Truyers C, Safin I, Beckwee D. Validity and Reproducibility of Inertial Physilog Sensors for Spatiotemporal Gait Analysis in Patients With Stroke. IEEE Trans Neural Syst Rehabil Eng. 2019 Sep;27(9):1865-1874. doi: 10.1109/TNSRE.2019.2930751. Epub 2019 Jul 24.
citation: Hebert D, Lindsay MP, McIntyre A, Kirton A, Rumney PG, Bagg S, Bayley M, Dowlatshahi D, Dukelow S, Garnhum M, Glasser E, Halabi ML, Kang E, MacKay-Lyons M, Martino R, Rochette A, Rowe S, Salbach N, Semenko B, Stack B, Swinton L, Weber V, Mayer M, Verrilli S, DeVeber G, Andersen J, Barlow K, Cassidy C, Dilenge ME, Fehlings D, Hung R, Iruthayarajah J, Lenz L, Majnemer A, Purtzki J, Rafay M, Sonnenberg LK, Townley A, Janzen S, Foley N, Teasell R. Canadian stroke best practice recommendations: Stroke rehabilitation practice guidelines, update 2015. Int J Stroke. 2016 Jun;11(4):459-84. doi: 10.1177/1747493016643553. Epub 2016 Apr 14.