UltrasoundNCT06941883
Ultrasound-Guided Versus Anatomically Guided Botulinum Toxin Injection in Spasticity in Adults in Tanta University Hospitals
An observational study of Ultrasound and Botulinum Toxin, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ultrasound, Botulinum Toxin, Spasticity
- What is being tested?
- Botulinum toxin injection under anatomical landmark and Ultrasound-guided botulinum toxin injection
- Type of treatment
- Injection or infusion
- How many people
- 68 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Jul 2023to 31 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age > 18 years old.
- Both sexes.
- Patients with muscle spasticity.
Who cannot join
- Patients with contraindications to botulinum toxin injection as allergy, myasthenia gravis, and cerebral palsy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Ultrasound, Botulinum Toxin, Spasticity, Adults
- Being tested
- Botulinum toxin injection under anatomical landmark, Ultrasound-guided botulinum toxin injection
- Medical subject headings
- Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin injection under anatomical landmarkDrug
Patients received botulinum toxin injections under the anatomical landmark.
Ultrasound-guided botulinum toxin injectionDrug
Patients received ultrasound-guided botulinum toxin injection
| Study group | Role | What they receive |
|---|---|---|
| Botulinum toxin injection under anatomical landmark | Patients received botulinum toxin injections under the anatomical landmark. Receives: Drug: Botulinum toxin injection under anatomical landmark | |
| Ultrasound-guided botulinum toxin injection | Patients received ultrasound-guided botulinum toxin injection Receives: Drug: Ultrasound-guided botulinum toxin injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after the procedure
Secondary outcomes (1)
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.
Measured: 6 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start16 Jul 2023
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UltrasoundStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Abdallah Ebrahim Elsaharty, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06941883
- Sponsor's protocol ID
- 36264MS248/7/23
- Status last verified
- Apr 2025
- First submitted
- 16 Apr 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Ultrasound-Guided Versus Anatomically Guided Botulinum Toxin Injection in Spasticity in Adults in Tanta University Hospitals
- ClinicalTrials.gov ID
- NCT06941883
- Acronym / sponsor ID
- 36264MS248/7/23
- Conditions
- Ultrasound, Botulinum Toxin, Spasticity, Adults
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 16 Jul 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botulinum toxin injection under anatomical landmark | – | Drug: Botulinum toxin injection under anatomical landmarkPatients received botulinum toxin injections under the anatomical landmark. |
| Ultrasound-guided botulinum toxin injection | – | Drug: Ultrasound-guided botulinum toxin injectionPatients received ultrasound-guided botulinum toxin injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age > 18 years old.
- Both sexes.
- Patients with muscle spasticity.
Key exclusion criteria (1 listed)
- Patients with contraindications to botulinum toxin injection as allergy, myasthenia gravis, and cerebral palsy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin injection under anatomical landmarkPatients received botulinum toxin injections under the anatomical landmark. | Drug | Botulinum toxin injection under anatomical landmark |
| Ultrasound-guided botulinum toxin injectionPatients received ultrasound-guided botulinum toxin injection | Drug | Ultrasound-guided botulinum toxin injection |
Primary outcome
Assessment the range of movement
Time frame: 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.
1 secondary outcome
Assessment the quality of life
Time frame: 6 months after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultrasound and Botulinum Toxin, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment the range of movement (time frame: 6 months after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.