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

Sisli Hamidiye Etfal Training and Research Hospital

Status and phase: Withdrawn; Phase 4

Conditions: Spasticity, Muscle; Botulinum Toxin; Cerebrovascular Disorders

Treatments: Drug: Botulinum toxin type A; Drug: %0,9 NaCl

Study type: Interventional

Funder types: Other

Identifiers

NCT05887479

042023

Details and patient eligibility

About

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).

Sex: All

Ages: 35 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

Study Group

Active Comparator group

Description:

This is the group that will be injected with botulinum toxin for spasticity and stretching exercises will be given.

Treatment:

Drug: Botulinum toxin type A

Control Group

Placebo Comparator group

Description:

This is the group that will be injected with %0,9 NaCl for spasticity and stretching exercises will be given.

Treatment:

Drug: %0,9 NaCl