Effect of Dry Needling on Spasticity in Stroke Survivors.

NCT ID: NCT05449951

Last Updated: 2022-07-08

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-04

Study Completion Date

2022-08-08

Brief Summary

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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

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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.

Conditions

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Spastic Hemiplegia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
The participants are blinded towards treatment groups.

Study Groups

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Dry needling

This intervention was for three weeks in which there are 2 sessions per week. Sterile, disposable dry needles brand of JIAJAN with size of 0.30x40mm were used. Intervention was initiated after palpation of muscles(flexor carpi radials and flexor carpi ulnaris).First cleaning the area through alcohol swabs. There is a point for FCR in medial forearm, to that point 4 cm below and 1 cm medial to the midpoint of crease of elbow was needled. There is a point for FCU at the center of the proximal third segment of a line from the medial epicondyle to the ulnar styloid process was needled.Then, in swift in-and-out motions around 5mm vertical motions without rotation the needle was manipulated .About 1 minute Dry needling was executed for each targeted area, in respect to the patient's level of tolerance. This was monitored by the physiotherapist throughout the session by asking for regular verbal feedback

Group Type EXPERIMENTAL

Dry needling

Intervention Type OTHER

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

The second group received sustained stretching protocol along with conventional therapy. Participants undergone the overall treatment sessions for three weeks (3weeks) and 2 sessions per week. The targeted muscles are wrist flexors (flexor carpi radials and flexor carpi ulnaris). Participants received 10 repetition with 30 seconds hold in each session for 10 minutes. Pre and post data in each session was measured through outcome measure tools

Group Type OTHER

sustained stretching

Intervention Type OTHER

sustained stretching is a treatment protocol in which muscle goes into a stretch position for period of time which reduce spasticity

Interventions

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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

Intervention Type OTHER

sustained stretching

sustained stretching is a treatment protocol in which muscle goes into a stretch position for period of time which reduce spasticity

Intervention Type OTHER

Eligibility Criteria

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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.

\-
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shifa Tameer-e-Millat University

OTHER

Sponsor Role lead

Responsible Party

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Nouman Khan

lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shifa tameer e millat university

Islamabad, Federal, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Facility Contacts

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Syed Ali Hussain, Phd*

Role: primary

03315191713

Nouman Khan, Ms- OMPT

Role: backup

03339378324

References

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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.

Reference Type BACKGROUND
PMID: 33076218 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25199825 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29683410 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31026521 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29986902 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24066015 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22666645 (View on PubMed)

Other Identifiers

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Raheela IRB # 280-21

Identifier Type: -

Identifier Source: org_study_id

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