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

NCT06941883 | Completed

• 1 other identifier: 36264MS248/7/23
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Ultrasound; Botulinum Toxin; Spasticity; Adults

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Assessment the quality of life

  6 months after the procedure

Study Arms (2)

Botulinum toxin injection under anatomical landmark

Patients received botulinum toxin injections under the anatomical landmark.

Drug: Botulinum toxin injection under anatomical landmark

Ultrasound-guided botulinum toxin injection

Patients received ultrasound-guided botulinum toxin injection

Drug: Ultrasound-guided botulinum toxin injection

Interventions

Botulinum toxin injection under anatomical landmark DRUG

Patients received botulinum toxin injections under the anatomical landmark.

Botulinum toxin injection under anatomical landmark

Ultrasound-guided botulinum toxin injection DRUG

Patients received ultrasound-guided botulinum toxin injection

Ultrasound-guided botulinum toxin injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Conditions

Muscle Spasticity

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Neuropsychiatry, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: April 24, 2025
• Study Start: July 16, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)