Clinical trial NCT05952830: Comparison of the Effects of Extracorporeal Shock Wave Therapy and Dry Needing
Official title: Comparison of the Effects of Extracorporeal Shock Wave Therapy and Dry Needing on Spasticity in Poststroke Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiplegia
Keywords: Hemiplegia
external corporeal shockwave therapy
dry needling
spasticity
Lead sponsor: Kirsehir Ahi Evran Universitesi
Sponsor class: OTHER
First posted: 2023-07-19
Enrollment: 20
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Jebsen Taylor Test of Hand Function (JTHF)
timeFrame: 1 month
measure: Purdue Pegboard Test (PPT)
timeFrame: 1 month
measure: 9 Hole Peg Test
timeFrame: 1 month
measure: Spasticity
timeFrame: 10 minutes
Secondary outcomes:
measure: Light Touch
timeFrame: 1 month
measure: Tactile Sense
timeFrame: 1 month
measure: Pain Sensation
timeFrame: 1 month
measure: 2 Point Discrimination
timeFrame: 1 month
measure: Visual Anolog Scale
timeFrame: 1 month
Other outcomes:
Locations:
city: Kırşehir
country: Turkey
facility: Ahi Evran University
state: Merkez
city: Kırşehir
country: Turkey
facility: Kırşehir Ahi Evran University
state: Merkez
Study officials:
affiliation: Karbala Health Department.
name: Hüseyin Abdul Razzaq Cabbar Sarefi, PT
role: STUDY_DIRECTOR
References: