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Effect of Dry Needling on Spasticity in Stroke Survivors.

Primary Purpose

Spastic Hemiplegia

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Dry needling
sustained stretching
Sponsored by
Shifa Tameer-e-Millat University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spastic Hemiplegia focused on measuring Dry needling, Modified Ashworth Scale, Goniometer, Range of Motion

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

-

Sites / Locations

  • Shifa tameer e millat universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Dry needling

Sustained stretching

Arm Description

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

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

Outcomes

Primary Outcome Measures

Modified Asworth sacle
it is used to measure spasticity which ranges from 0-4
Goniometer
to measure range of motion of wrist extensors of maximum range 70 degrees
Motor Assesment Scale
2 components of this scale is used to measure hand function recovery

Secondary Outcome Measures

Full Information

First Posted
July 4, 2022
Last Updated
July 4, 2022
Sponsor
Shifa Tameer-e-Millat University
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1. Study Identification

Unique Protocol Identification Number
NCT05449951
Brief Title
Effect of Dry Needling on Spasticity in Stroke Survivors.
Official Title
Effect of Dry Needling on Spasticity in Stroke Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 4, 2022 (Actual)
Primary Completion Date
August 4, 2022 (Anticipated)
Study Completion Date
August 8, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shifa Tameer-e-Millat University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spastic Hemiplegia
Keywords
Dry needling, Modified Ashworth Scale, Goniometer, Range of Motion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
Masking Description
The participants are blinded towards treatment groups.
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dry needling
Arm Type
Experimental
Arm Description
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
Arm Title
Sustained stretching
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Dry needling
Intervention Description
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
Intervention Name(s)
sustained stretching
Intervention Description
sustained stretching is a treatment protocol in which muscle goes into a stretch position for period of time which reduce spasticity
Primary Outcome Measure Information:
Title
Modified Asworth sacle
Description
it is used to measure spasticity which ranges from 0-4
Time Frame
3 weeks
Title
Goniometer
Description
to measure range of motion of wrist extensors of maximum range 70 degrees
Time Frame
3 weeks
Title
Motor Assesment Scale
Description
2 components of this scale is used to measure hand function recovery
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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. -
Facility Information:
Facility Name
Shifa tameer e millat university
City
Islamabad
State/Province
Federal
ZIP/Postal Code
44000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Syed Ali Hussain, Phd*
Phone
03315191713
Email
alihussain_dpt.ahs@stmu.edu.pk
First Name & Middle Initial & Last Name & Degree
Nouman Khan, Ms- OMPT
Phone
03339378324
Email
nouman_drs.ahs@stmu.edu.pk
First Name & Middle Initial & Last Name & Degree
Raheela Amjid, MSPT*

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33076218
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.
Results Reference
background
PubMed Identifier
25199825
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.
Results Reference
background
PubMed Identifier
29683410
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.
Results Reference
background
PubMed Identifier
31026521
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.
Results Reference
background
PubMed Identifier
29986902
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.
Results Reference
background
PubMed Identifier
24066015
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.
Results Reference
background
PubMed Identifier
22666645
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.
Results Reference
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Effect of Dry Needling on Spasticity in Stroke Survivors.

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