Comparison of the Effects of Extracorporeal Shock Wave Therapy and Dry Needing

NCT ID: NCT05952830

Last Updated: 2023-07-19

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

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-21

Study Completion Date

2021-10-26

Brief Summary

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Effective treatment of spasticity after stroke is a very important and serious problem. Some of the therapeutic approach include physiotherapy and medication. In the recent years external corporeal shockwave therapy and dry needling are commonly used for management of spasticity and pain after stroke. the purpose of this study is the comparative study between effectiveness of external corporeal shockwave therapy (ESWT) and dry needling (DN) on spasticity, pain, and upper limb function and sensation in individuals with hemiplegia.

Methods: In this study, individuals with hemiplegia were randomized 1:1 to parallel ESWT-Group (n = 10) or DN group (CG) (n = 10). Upper Extremity Functions, Sensation, Spasticity and Pain were evaluated. All measurement indicators were be evaluate before treatment and immediately after one session treatment. Mixedmodel repeated measured ANOVAs were then employed to determine if a group\*time interaction existed on the effects of the treatment on each outcome variable for each group as the between-subjects variable and time as the within-subjects variables.

Detailed Description

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Effective treatment of spasticity after stroke is a very important and serious problem. Some of the therapeutic approach include physiotherapy and medication. In the recent years external corporeal shockwave therapy and dry needling are commonly used for management of spasticity and pain after stroke. the purpose of this study is the comparative study between effectiveness of external corporeal shockwave therapy (ESWT) and dry needling (DN) on spasticity, pain, and upper limb function and sensation in individuals with hemiplegia.

Methods: In this study, individuals with hemiplegia were randomized 1:1 to parallel ESWT-Group (n = 10) or DN group (CG) (n = 10). Upper Extremity Functions, Sensation, Spasticity and Pain were evaluated. All measurement indicators were be evaluate before treatment and immediately after one session treatment. Mixedmodel repeated measured ANOVAs were then employed to determine if a group\*time interaction existed on the effects of the treatment on each outcome variable for each group as the between-subjects variable and time as the within-subjects variables.

Conditions

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Hemiplegia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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ESWT Group

ESWT Group: external corporeal shockwave therapy subjects in ESWT-group receiving one session shock wave therapy given 6,000 impulses at 0.06-0.07 mJ/mm2 (1.2-1.4 bar) at 18 Hz on biceps brachii

Group Type ACTIVE_COMPARATOR

ESWT group

Intervention Type OTHER

subjects in ESWT-group receiving one session shock wave therapy given 6,000 impulses at 0.06-0.07 mJ/mm2 (1.2-1.4 bar) at 18 Hz on biceps brachii (17). Subjects in DN-group receiving dry needling using disposable stain less steel sterilized needles, 0.25×0.30. DN perform with patients in supine position, arm away from the trunk, and forearm in supination. The fast-in and fast-out cone shape technique adopt and each muscle needled for one minute

DN Group

DN Group: dry needling Subjects in DN-group receiving dry needling using disposable stain less steel sterilized needles, 0.25×0.30. DN perform with patients in supine position, arm away from the trunk, and forearm in supination. The fast-in and fast-out cone shape technique adopt and each muscle needled for one minute

Group Type EXPERIMENTAL

ESWT group

Intervention Type OTHER

subjects in ESWT-group receiving one session shock wave therapy given 6,000 impulses at 0.06-0.07 mJ/mm2 (1.2-1.4 bar) at 18 Hz on biceps brachii (17). Subjects in DN-group receiving dry needling using disposable stain less steel sterilized needles, 0.25×0.30. DN perform with patients in supine position, arm away from the trunk, and forearm in supination. The fast-in and fast-out cone shape technique adopt and each muscle needled for one minute

DN group

Intervention Type OTHER

Subjects in DN-group receiving dry needling using disposable stain less steel sterilized needles, 0.25×0.30. DN perform with patients in supine position, arm away from the trunk, and forearm in supination. The fast-in and fast-out cone shape technique adopt and each muscle needled for one minute

Interventions

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ESWT group

subjects in ESWT-group receiving one session shock wave therapy given 6,000 impulses at 0.06-0.07 mJ/mm2 (1.2-1.4 bar) at 18 Hz on biceps brachii (17). Subjects in DN-group receiving dry needling using disposable stain less steel sterilized needles, 0.25×0.30. DN perform with patients in supine position, arm away from the trunk, and forearm in supination. The fast-in and fast-out cone shape technique adopt and each muscle needled for one minute

Intervention Type OTHER

DN group

Subjects in DN-group receiving dry needling using disposable stain less steel sterilized needles, 0.25×0.30. DN perform with patients in supine position, arm away from the trunk, and forearm in supination. The fast-in and fast-out cone shape technique adopt and each muscle needled for one minute

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* being between the age of 25-65
* having been diagnosed with a stroke by a specialist, first time stroke
* BBM spasticity, ability to understand command actions
* stable vital signs, unchanged drug doses that might affect muscle spasticity
* taking no antispastic medication
* with Modified Ashworth Scale (MAS) score more than 1 and less than 4 for the upper limb flexor tension

Exclusion Criteria

* received Botox, alcohol or phenol block treatments
* received elbow joint surgical orthopedic surgery
* history of epilepsy
* severe mental disorders
* malignant tumors; and limb venous thrombosis
* sensory disturbances
* the presence of any other neurological disorders
* currently receiving other treatments
* ESWT contraindications
* exhibit fear of needles; or have any contraindication to DN
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kirsehir Ahi Evran Universitesi

OTHER

Sponsor Role lead

Responsible Party

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Buket Büyükturan

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hüseyin Abdul Razzaq Cabbar Sarefi, PT

Role: STUDY_DIRECTOR

Karbala Health Department.

Locations

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Ahi Evran University

Kırşehir, Merkez, Turkey (Türkiye)

Site Status

Kırşehir Ahi Evran University

Kırşehir, Merkez, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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560

Identifier Type: -

Identifier Source: org_study_id

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