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

• Sponsor: Sisli Hamidiye Etfal Training and Research Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05887479
• Collaborator: (none)
• Enrollment: 30
• Arms: 2
• Anticipated Duration (Months): 2.7

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Cerebrovascular Disorders; Spasticity, Muscle; Botulinum Toxin	Drug: Botulinum toxin type A; Drug: %0,9 NaCl	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: May 25, 2023
• Anticipated Primary Completion Date: Jul 15, 2023
• Anticipated Study Completion Date: Aug 15, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

Secondary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aylin Ayyıldız, Medical Doctor, Sisli Hamidiye Etfal Training and Research Hospital
• ClinicalTrials.gov Identifier: NCT05887479
• Other Study ID Numbers: 042023
• First Posted: Jun 2, 2023
• Last Update Posted: Jun 2, 2023
• Last Verified: May 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Muscle Spasticity; Cerebrovascular Disorders; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA

Study Results

No Results Posted as of Jun 2, 2023