Clinical trial NCT05449951: Effect of Dry Needling on Spasticity in Stroke Survivors.
Official title: Effect of Dry Needling on Spasticity in Stroke Survivors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spastic Hemiplegia
Keywords: Dry needling
Modified Ashworth Scale
Goniometer
Range of Motion
Lead sponsor: Shifa Tameer-e-Millat University
Sponsor class: OTHER
First posted: 2022-07-08
Enrollment: 34
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are two groups.Group A experimental group which receive dry needling protocol along with conventional therapy.Group B is control group which receive sustained stretching protocol along with conventional therapy.
Primary purpose: TREATMENT

Brief summary: Stroke is a disruption of blood flow to brain either due to clot formation or rupturing of arteries.It is a leading cause of disability worldwide with many consequences and spasticity is one of them.Spasticity is a resistance to passive stretch which disturbs patient quality of life and interrupt activity of daily living.there are multiple options to treat spasticity which includes both pharmacological and non-pharmacological treatments.

Detailed description: Stroke is a global issue and burden of disease is high in Asia.the burden of disease is alarming due to its consequences and spasticity is one of them.According to the lance definition clinical practice is still based which is too narrow. Spasticity, according to Lance, is a motor disease characterized by a velocity-dependent increase in tonic stretch reflexes (muscle tone) with excessive tendon jerks, due to hyper excitability stretch reflex.Furthermore, long-term untreated spasticity can cause discomfort, contractures, and deformities, which can lead to functional issues such as mobility limitations, reliance on (ADL), and a lower quality of life.There is multiple option to treat spasticity including pharmacological and rehabilitation Pharmacological treatments that can be focal or systematic and have partial effects and eventually need of physical therapy There are many PT procedures which includes stretching neurodevelopment techniques and many others to prevent spasticity.

Eligibility criteria: Inclusion Criteria:

- 1: Ischemic or hemorrhagic stroke and includes any of the artery 2: Hemiplegia 3: Chronic stroke (stroke at least 6 months before the trial) 4: Present a level of spasticity equal or greater than between 1 to 3 according to Modified Ashworth Scale.

5: Preserve cognitive capacity according to 6 cognitive items test (6CIT), Montreal cognitive assessment (MoCA) and Mini mental state examination (MMSE)

Exclusion Criteria:

1: Insurmountable fear of needles. 2: Wrist fracture. 3: Have received previous treatment with dry needling. 4: Have progressive or severe neurological disease.

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Primary outcomes:
measure: Modified Asworth sacle
timeFrame: 3 weeks
measure: Goniometer
timeFrame: 3 weeks
measure: Motor Assesment Scale
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Shifa tameer e millat university
state: Federal
Study officials:
References:
citation: Kuriakose D, Xiao Z. Pathophysiology and Treatment of Stroke: Present Status and Future Perspectives. Int J Mol Sci. 2020 Oct 15;21(20):7609. doi: 10.3390/ijms21207609.
citation: Salom-Moreno J, Sanchez-Mila Z, Ortega-Santiago R, Palacios-Cena M, Truyol-Dominguez S, Fernandez-de-las-Penas C. Changes in spasticity, widespread pressure pain sensitivity, and baropodometry after the application of dry needling in patients who have had a stroke: a randomized controlled trial. J Manipulative Physiol Ther. 2014 Oct;37(8):569-79. doi: 10.1016/j.jmpt.2014.06.003. Epub 2014 Sep 8.
citation: Hadi S, Khadijeh O, Hadian M, Niloofar AY, Olyaei G, Hossein B, Calvo S, Herrero P. The effect of dry needling on spasticity, gait and muscle architecture in patients with chronic stroke: A case series study. Top Stroke Rehabil. 2018 Jul;25(5):326-332. doi: 10.1080/10749357.2018.1460946. Epub 2018 Apr 23.
citation: Ghaffari MS, Shariat A, Honarpishe R, Hakakzadeh A, Cleland JA, Haghighi S, Barghi TS. Concurrent Effects of Dry Needling and Electrical Stimulation in the Management of Upper Extremity Hemiparesis. J Acupunct Meridian Stud. 2019 Jun;12(3):90-94. doi: 10.1016/j.jams.2019.04.004. Epub 2019 Apr 23.
citation: Sanchez-Mila Z, Salom-Moreno J, Fernandez-de-Las-Penas C. Effects of dry needling on post-stroke spasticity, motor function and stability limits: a randomised clinical trial. Acupunct Med. 2018 Dec;36(6):358-366. doi: 10.1136/acupmed-2017-011568. Epub 2018 Jul 9.
citation: Hong CZ. Needling therapy for myofascial pain control. Evid Based Complement Alternat Med. 2013;2013:946597. doi: 10.1155/2013/946597. Epub 2013 Aug 26. No abstract available.
citation: Kolber MJ, Hanney WJ. The reliability and concurrent validity of shoulder mobility measurements using a digital inclinometer and goniometer: a technical report. Int J Sports Phys Ther. 2012 Jun;7(3):306-13.