The Effect of Ultrasound-Guided Botulinum Toxin Injections on Pain, Functionality, Spasticity, and Range of Motion in Patients With Post-Stroke Upper Extremity Spasticity
Overview
- Phase
- Phase 4
- Intervention
- Botulinum toxin type A
- Conditions
- Cerebrovascular Disorders
- Sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Primary Endpoint
- The Fugl-Meyer assessment scale
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
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).
Investigators
Aylin Ayyıldız
Medical Doctor
Sisli Hamidiye Etfal Training and Research Hospital
Eligibility Criteria
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
Arms & Interventions
Study Group
This is the group that will be injected with botulinum toxin for spasticity and stretching exercises will be given.
Intervention: Botulinum toxin type A
Control Group
This is the group that will be injected with %0,9 NaCl for spasticity and stretching exercises will be given.
Intervention: %0,9 NaCl
Outcomes
Primary Outcomes
The Fugl-Meyer assessment scale
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Pain - Visual Analog Scale(3 months after treatment)
- Range of Motion(3 months after treatment)
- Modified Ashworth Scale(3 months after treatment)
- The Fugl-Meyer assessment scale(3 months after treatment)