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Spastic HemiplegiaNCT05449951

Effect of Dry Needling on Spasticity in Stroke Survivors.

A study testing Dry needling and sustained stretching in people with Spastic Hemiplegia, run by Shifa Tameer-e-Millat University at 1 site in Pakistan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 35 to 65 years
Conditions the study is for
Spastic Hemiplegia
What is being tested?
Dry needling and sustained stretching
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 sitePakistan
Study dates
4 Jul 2022to 8 Aug 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site, 1 recruiting

  • Shifa tameer e millat university

    Islamabad, Federal, 44000

    Syed Ali Hussain, Phd*, 03315191713, alihussain_dpt.ahs@stmu.edu.pk

    Nouman Khan, Ms- OMPT, 03339378324, nouman_drs.ahs@stmu.edu.pk

    Recruiting

Other trials in Pakistan

About this study

Official title: 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.

Read the 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.

Being tested
Dry needling, sustained stretching
Keywords
Dry needling, Modified Ashworth Scale, Goniometer, Range of Motion
Medical subject headings
Hemiplegia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dry needlingOther

    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 stretchingOther

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

Study groups in NCT05449951
Study groupRoleWhat they receive
Dry needlingExperimentalThis 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
Receives: Other: Dry needling
Sustained stretchingOtherThe 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
Receives: Other: sustained stretching

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Modified Asworth sacle

    it is used to measure spasticity which ranges from 0-4

    Measured: 3 weeks

  2. Goniometer

    to measure range of motion of wrist extensors of maximum range 70 degrees

    Measured: 3 weeks

  3. Motor Assesment Scale

    2 components of this scale is used to measure hand function recovery

    Measured: 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2022
  2. Study start4 Jul 2022
  3. Primary completion4 Aug 2022 (estimated)
  4. Study completion8 Aug 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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
Single blind
Who is masked
Participant
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05449951
Sponsor's protocol ID
Raheela IRB # 280-21
Status last verified
Jul 2022
First submitted
4 Jul 2022
Last updated
8 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33076218

  • 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.

    PubMed 25199825

  • 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.

    PubMed 29683410

  • 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.

    PubMed 31026521

  • 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.

    PubMed 29986902

  • 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.

    PubMed 24066015

  • 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.

    PubMed 22666645

Questions about this trial

What is this clinical trial studying?

A study testing Dry needling and sustained stretching in people with Spastic Hemiplegia, run by Shifa Tameer-e-Millat University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modified Asworth sacle (time frame: 3 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05449951, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2022.

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