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

Cerebrovascular Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05887479
• Other study ID #: 042023
• Status: Withdrawn
• Phase: Phase 4
• Start date: May 25, 2023
• Est. completion date: August 15, 2023

Study information

• Verified date: November 2023
• Source: Sisli Hamidiye Etfal Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 15, 2023
• Est. primary completion date: July 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Botulinum Toxin
• Cerebrovascular Disorders
• Muscle Spasticity
• Spasticity, Muscle

Intervention

Drug:
• Botulinum toxin type A
Toxin of Clostridium Botulinum
• %0,9 NaCl
%0,9 NaCl

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sisli Hamidiye Etfal Training and Research Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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