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

Phase 4

Withdrawn

• Conditions: Spasticity, Muscle; Cerebrovascular Disorders; Botulinum Toxin
• Interventions: Drug: %0,9 NaCl; Drug: Botulinum toxin type A

• Registration Number: NCT05887479
• Lead Sponsor: Sisli Hamidiye Etfal Training and Research Hospital

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-09
• Study First Submitted QC: 2023-05-24
• Study Start: 2023-05-25
• Study First Posted: 2023-06-02
• Primary Completion: 2023-07-15
• Study Completion: 2023-08-15
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	%0,9 NaCl	This is the group that will be injected with %0,9 NaCl for spasticity and stretching exercises will be given.
Study Group	Botulinum toxin type A	This is the group that will be injected with botulinum toxin for spasticity and stretching exercises will be given.

Primary Outcome Measures

Name	Time	Method
The Fugl-Meyer assessment scale	2 weeks after treatment	The Fugl-Meyer assessment scale (FMAS) will be used to evaluate the motor functions of the upper extremity.
Range of Motion	2 weeks after treatment	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.
Modified Ashworth Scale	2 weeks after treatment	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.
Pain - Visual Analog Scale	2 weeks after treatment	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.

Secondary Outcome Measures

Name	Time	Method
Pain - Visual Analog Scale	3 months after treatment	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.
Range of Motion	3 months after treatment	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.
Modified Ashworth Scale	3 months after treatment	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.
The Fugl-Meyer assessment scale	3 months after treatment	The Fugl-Meyer assessment scale (FMAS) will be used to evaluate the motor functions of the upper extremity.