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

Completed

• Conditions: Ultrasound; Botulinum Toxin; Spasticity; Adults
• Interventions: Drug: Botulinum toxin injection under anatomical landmark; Drug: Ultrasound-guided botulinum toxin injection

• Registration Number: NCT06941883
• Lead Sponsor: Tanta University

Brief Summary

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.

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 Timeline

• Study Start: 2023-07-16
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31
• Status Verified: 2025-04
• Study First Submitted: 2025-04-16
• Study First Submitted QC: 2025-04-16
• Last Update Submitted: 2025-04-16
• Study First Posted: 2025-04-24
• Last Update Posted: 2025-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Botulinum toxin injection under anatomical landmark	Botulinum toxin injection under anatomical landmark	Patients received botulinum toxin injections under the anatomical landmark.
Ultrasound-guided botulinum toxin injection	Ultrasound-guided botulinum toxin injection	Patients received ultrasound-guided botulinum toxin injection

Primary Outcome Measures

Name	Time	Method
Assessment the range of movement	6 months after the procedure	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.

Secondary Outcome Measures

Name	Time	Method
Assessment the quality of life	6 months after the procedure	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.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt