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

Primary Purpose

Cerebrovascular Disorders, Spasticity, Muscle, Botulinum Toxin

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Botulinum toxin type A
%0,9 NaCl
Sponsored by
Sisli Hamidiye Etfal Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrovascular Disorders

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Study Group

    Control Group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    The Fugl-Meyer assessment scale
    The Fugl-Meyer assessment scale (FMAS) will be used to evaluate the motor functions of the upper extremity.

    Secondary Outcome Measures

    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.
    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.
    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.
    The Fugl-Meyer assessment scale
    The Fugl-Meyer assessment scale (FMAS) will be used to evaluate the motor functions of the upper extremity.

    Full Information

    First Posted
    April 9, 2023
    Last Updated
    May 24, 2023
    Sponsor
    Sisli Hamidiye Etfal Training and Research Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05887479
    Brief 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
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 25, 2023 (Anticipated)
    Primary Completion Date
    July 15, 2023 (Anticipated)
    Study Completion Date
    August 15, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sisli Hamidiye Etfal Training and Research Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebrovascular Disorders, Spasticity, Muscle, Botulinum Toxin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Study Group
    Arm Type
    Active Comparator
    Arm Description
    This is the group that will be injected with botulinum toxin for spasticity and stretching exercises will be given.
    Arm Title
    Control Group
    Arm Type
    Placebo Comparator
    Arm Description
    This is the group that will be injected with %0,9 NaCl for spasticity and stretching exercises will be given.
    Intervention Type
    Drug
    Intervention Name(s)
    Botulinum toxin type A
    Intervention Description
    Toxin of Clostridium Botulinum
    Intervention Type
    Drug
    Intervention Name(s)
    %0,9 NaCl
    Intervention Description
    %0,9 NaCl
    Primary Outcome Measure Information:
    Title
    Pain - Visual Analog Scale
    Description
    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.
    Time Frame
    2 weeks after treatment
    Title
    Range of Motion
    Description
    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.
    Time Frame
    2 weeks after treatment
    Title
    Modified Ashworth Scale
    Description
    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.
    Time Frame
    2 weeks after treatment
    Title
    The Fugl-Meyer assessment scale
    Description
    The Fugl-Meyer assessment scale (FMAS) will be used to evaluate the motor functions of the upper extremity.
    Time Frame
    2 weeks after treatment
    Secondary Outcome Measure Information:
    Title
    Pain - Visual Analog Scale
    Description
    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.
    Time Frame
    3 months after treatment
    Title
    Range of Motion
    Description
    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.
    Time Frame
    3 months after treatment
    Title
    Modified Ashworth Scale
    Description
    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.
    Time Frame
    3 months after treatment
    Title
    The Fugl-Meyer assessment scale
    Description
    The Fugl-Meyer assessment scale (FMAS) will be used to evaluate the motor functions of the upper extremity.
    Time Frame
    3 months after treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

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