Ultrasound-Guided Versus Anatomically Guided Botulinum Toxin Injection in Spasticity in Adults in Tanta University Hospitals

A Study of Ultrasound-Guided Versus Anatomically Guided Botulinum Toxin Injection in Spasticity in Adults in Tanta University Hospitals

This study aimed to compare the safety and outcome of ultrasound (US)- guided botulinum toxin (BoNT) injection and anatomically guided injection in muscle spasticity of different causes in adults.

Study Overview

• Status: Completed
• Conditions: Ultrasound; Adults; Spasticity; Botulinum Toxin
• Intervention / Treatment: Drug: Botulinum toxin injection under anatomical landmark; Drug: Ultrasound-guided botulinum toxin injection

Detailed Description

One of the major complications of neurological diseases is spasticity which is defined as an increased velocity-dependent muscle tone.

A large volume of clinical data has demonstrated the efficacy and safety of botulinum toxin type A (BoNT-A) products for treating conditions such as spasticity.

• Study Type: Observational
• Enrollment (Actual): 68

Contacts and Locations

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Tanta university

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

This prospective case-controlled study was carried out on 68 patients aged > 18 years old, both sexes, with muscle spasticity, planned and indicated for BoNT injection according to recent guidelines. The study was done from July 2023 to July 2024 after approval from the Ethical Committee Tanta University Hospitals, Tanta, Egypt.

Description

Inclusion Criteria:

• Age > 18 years old.
• Both sexes.
• Patients with muscle spasticity.

Exclusion Criteria:

- Patients with contraindications to botulinum toxin injection as allergy, myasthenia gravis, and cerebral palsy.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Botulinum toxin injection under anatomical landmark; Patients received botulinum toxin injections under the anatomical landmark.	Drug: Botulinum toxin injection under anatomical landmark; Patients received botulinum toxin injections under the anatomical landmark.
Ultrasound-guided botulinum toxin injection; Patients received ultrasound-guided botulinum toxin injection	Drug: Ultrasound-guided botulinum toxin injection; Patients received ultrasound-guided botulinum toxin injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment the range of movement	The range of movement regarding forearm pronation, thumb flexion, ankle inversion and fingers flexion according to modified Ashworth scale (MAS): score zero indicate no increase in tone, score 1 indicate slight increase in tone, catch or release at end range of motion (ROM), score 1 + indicate a slight increase in tone catch, release, resistance through rest ROM (1/2 ROM), score 2 indicate more marked increase in tone through ROM but affected part moved easily, score 3 indicate a considerable increase in tone, passive movement difficult, score 4 indicate affected part in rigid flexion and extension. It was assessed after three and six months.	6 months after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment the quality of life	Patients' quality of life (QOL) was assessed before and after intervention with the World Health Organization (WHO)-QOL scale). The WHOQOL is a 26-item instrument consisting of four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items); it also contains QOL and general health items. Each individual item of the WHOQOL-BREF is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale. The scores are then transformed linearly to a 0-100 scale.	6 months after the procedure

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2023
• Primary Completion (Actual): July 31, 2024
• Study Completion (Actual): July 31, 2024

Study Registration Dates

• First Submitted: April 16, 2025
• First Submitted That Met QC Criteria: April 16, 2025
• First Posted (Actual): April 24, 2025

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 16, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Muscle Spasticity; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Membrane Transport Modulators; Cholinergic Agents; Acetylcholine Release Inhibitors; Botulinum Toxins
• Other Study ID Numbers: 36264MS248/7/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

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