Effect of Dry Needling on Spasticity in Stroke Survivors.

Spastic Hemiplegia Clinical Trial

Official title:

Effect of Dry Needling on Spasticity in Stroke Survivors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05449951
• Other study ID #: Raheela IRB # 280-21
• Status: Recruiting
• Phase: N/A
• Start date: July 4, 2022
• Est. completion date: August 8, 2022

Study information

• Verified date: July 2022
• Source: Shifa Tameer-e-Millat University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: August 8, 2022
• Est. primary completion date: August 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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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Related Conditions & MeSH terms

• Hemiplegia
• Spastic Hemiplegia

Intervention

Other:
• Dry needling
In dry needling filiform needle without a bore is used to mimic acupuncture t beyond the use of medicines. On the basis of purpose process and skill level it differs from acupuncture. DN is frequently used to treat pain caused by musculoskeletal structures, including as myofascial pain disorders
• sustained stretching
sustained stretching is a treatment protocol in which muscle goes into a stretch position for period of time which reduce spasticity

Locations

Country	Name	City	State
Pakistan	Shifa tameer e millat university	Islamabad	Federal

Sponsors (1)

Lead Sponsor	Collaborator
Shifa Tameer-e-Millat University

Country where clinical trial is conducted

Pakistan, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View Citation

Kuriakose D, Xiao Z. Pathophysiology and Treatment of Stroke: Present Status and Future Perspectives. Int J Mol Sci. 2020 Oct 15;21(20). pii: E7609. doi: 10.3390/ijms21207609. Review. — View Citation

Salom-Moreno J, Sánchez-Mila Z, Ortega-Santiago R, Palacios-Ceña M, Truyol-Domínguez S, Fernández-de-las-Peñas 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. — View Citation

Sánchez-Mila Z, Salom-Moreno J, Fernández-de-Las-Peñas 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Asworth sacle	it is used to measure spasticity which ranges from 0-4	3 weeks
Primary	Goniometer	to measure range of motion of wrist extensors of maximum range 70 degrees	3 weeks
Primary	Motor Assesment Scale	2 components of this scale is used to measure hand function recovery	3 weeks