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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06941883
Enrollment
68
Registered
2025-04-24
Start date
2023-07-16
Completion date
2024-07-31
Last updated
2025-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adults, Botulinum Toxin, Spasticity, Ultrasound

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.

Interventions

DRUGBotulinum toxin injection under anatomical landmark

Patients received botulinum toxin injections under the anatomical landmark.

Patients received ultrasound-guided botulinum toxin injection

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Assessment the range of movement6 months after the procedureThe 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

MeasureTime frameDescription
Assessment the quality of life6 months after the procedurePatients' 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026