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

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).

Study Overview

• Status: Withdrawn
• Conditions: Cerebrovascular Disorders; Spasticity, Muscle; Botulinum Toxin
• Intervention / Treatment: Drug: Botulinum toxin type A; Drug: %0,9 NaCl

• Study Type: Interventional
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sisli Hamidiye Etfal Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 25, 2023
• Primary Completion (Estimated): July 15, 2023
• Study Completion (Estimated): August 15, 2023

Study Registration Dates

• First Submitted: April 9, 2023
• First Submitted That Met QC Criteria: May 24, 2023
• First Posted (Actual): June 2, 2023

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Muscle Spasticity; Cerebrovascular Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: 042023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No