The Effect of Ultrasound-Guided Botulinum Toxin Injections on Pain, Functionality, Spasticity, and Range of Motion in Patients With Post-Stroke Upper Extremity Spasticity

Study Overview
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Brief Summary
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The patients between the ages of 35-80 who developed spasticity in the upper extremity after stroke will be included.. Botulinum toxin(BT-A) injection will be applied to the study group(n=16) and placebo injection to the control group(n=15) in addition to conventional rehabilitation and stretching exercises. Evaluations will be made before the treatment, in the 2nd week, and in 3rd month after the treatment. Pain relief will be evaluated with the Visual Analog Scale(VAS) and spasticity assessment will be done with the Modified Ashworth Scale(MAS). The functionality will be evaluated with Fugl Meyer Assessment Scale(FMAS) and Box Block Test(BBT).

Official Title
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The Effect of Ultrasound-Guided Botulinum Toxin Injections on Pain, Functionality, Spasticity, and Range of Motion in Patients With Post-Stroke Upper Extremity Spasticity

Conditions
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Cerebrovascular Disorders, Spasticity, Muscle, Botulinum Toxin

Intervention / Treatment
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* Drug: Botulinum toxin type A
* Drug: %0,9 NaCl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: hemiplegia due to a cerebrovascular accident at least 1 month ago cognitively competent have spasticity of 1 and above according to the Modified Ashworth Scale receive at least 3 cubes in the Box Block Test Exclusion Criteria: Patients with upper extremity brachial plexus lesions, shoulder subluxation, arthritis and joint contracture, neglect syndrome, cerebellar and brain stem lesions those who did not accept the study

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Study Group<br>This is the group that will be injected with botulinum toxin for spasticity and stretching exercises will be given. | Drug: Botulinum toxin type A<br>* Toxin of Clostridium Botulinum<br>|
| Placebo Comparator: Control Group<br>This is the group that will be injected with %0,9 NaCl for spasticity and stretching exercises will be given. | Drug: %0,9 NaCl<br>* %0,9 NaCl<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain - Visual Analog Scale | The shoulder pain of the patients will be evaluated during passive movement of the shoulder joint. The Visual Analogue Scale (VAS), a score between 0 and 10, will be used in the evaluation. | 2 weeks after treatment | 
| Range of Motion | Passive flexion, abduction and external rotation of the shoulder, supination of the elbow, and extension of the wrist will be evaluated by the same physician by goniometry. In addition, elbow, proximal interphalangeal, and distal interphalangeal joints will be evaluated as a limitation of extension. | 2 weeks after treatment | 
| Modified Ashworth Scale | The modified Ashworth Scale (MAS) will be used to evaluate spasticity. The adductor, internal rotator of shoulder, flexor of elbow, wrist and finger, pronator of elbow spasticities will be evaluated using MAS while the patient was in the sitting position. | 2 weeks after treatment | 
| The Fugl-Meyer assessment scale | The Fugl-Meyer assessment scale (FMAS) will be used to evaluate the motor functions of the upper extremity. | 2 weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain - Visual Analog Scale | The shoulder pain of the patients will be evaluated during passive movement of the shoulder joint. The Visual Analogue Scale (VAS), a score between 0 and 10, will be used in the evaluation. | 3 months after treatment | 
| Range of Motion | Passive flexion, abduction and external rotation of the shoulder, supination of the elbow, and extension of the wrist will be evaluated by the same physician by goniometry. In addition, elbow, proximal interphalangeal, and distal interphalangeal joints will be evaluated as a limitation of extension. | 3 months after treatment | 
| Modified Ashworth Scale | The modified Ashworth Scale (MAS) will be used to evaluate spasticity. The adductor, internal rotator of shoulder, flexor of elbow, wrist and finger, pronator of elbow spasticities will be evaluated using MAS while the patient was in the sitting position. | 3 months after treatment | 
| The Fugl-Meyer assessment scale | The Fugl-Meyer assessment scale (FMAS) will be used to evaluate the motor functions of the upper extremity. | 3 months after treatment |