Effect of Dry Needling on Spasticity in Stroke Survivors.

July 4, 2022 updated by: Nouman Khan, Shifa Tameer-e-Millat University

Effect of Dry Needling on Spasticity in Stroke Survivors

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Federal
      • Islamabad, Federal, Pakistan, 44000
        • Recruiting
        • Shifa Tameer e Millat University
        • Contact:
        • Principal Investigator:
          • Raheela Amjid, MSPT*

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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
Other: 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
Other: sustained stretching
sustained stretching is a treatment protocol in which muscle goes into a stretch position for period of time which reduce spasticity

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shifa Tameer-e-Millat University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 4, 2022

Primary Completion (Anticipated)

August 4, 2022

Study Completion (Anticipated)

August 8, 2022

Study Registration Dates

First Submitted

July 4, 2022

First Submitted That Met QC Criteria

July 4, 2022

First Posted (Actual)

July 8, 2022

Study Record Updates

Last Update Posted (Actual)

July 8, 2022

Last Update Submitted That Met QC Criteria

July 4, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Raheela IRB # 280-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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