Ultrasound Diagnostic, MRI FusionNCT06091059
Ultrasound - MRI Fusion Guided Injections in Muscles
An observational study of Ultrasound Diagnostic, MRI Fusion, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust at 1 site in United Kingdom.
Trial summary
This study is using a new technology of combining MRI and ultrasound images to help guide the injection into the correct muscles. Combining MRI images with real-time ultrasound images is a new technology which has recently become available. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ultrasound Diagnostic, MRI Fusion
- What is being tested?
- Ultrasound MRI fusion
- Type of treatment
- Injection or infusion
- How many people
- 7 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Apr 2024to 8 Jun 2026
- 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: - All adult patients with capacity and requiring an ultrasound guided Botox injection in the Radiology Department will be invited to take part in the study.
Who may be able to join
- All adult patients with capacity and requiring an ultrasound guided Botox injection in the Radiology Department will be invited to take part in the study.
Who cannot join
- Children. People who cannot consent. Patients with contra-indications to MRI scanning
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Robert Jones and Agnes hunt
Oswestry, Shropshire, SY10 7AG
About this study
This study is using a new technology of combining MRI and ultrasound images to help guide the injection into the correct muscles.
Combining MRI images with real-time ultrasound images is a new technology which has recently become available. Sometimes ultrasound images can be difficult to interpret, especially when there are problems with stiffness in the muscles. The MRI images create a "road-map" to help understand the ultrasound images at the time of the injection. This may help guide the injection, compared with using ultrasound alone. This technique has not currently been used in muscle injections, therefore we would like to use it as part of a research study.
This study is comparing current standard practice of using ultrasound guidance alone versus ultrasound guidance with an MRI road-map to direct muscle Botox injections.
Read the detailed description
Potential participants will be identified by referrals for Botox injections within the Radiology. They will be sent a copy of the Information leaflet. A week before the potential participant is due in Radiology, they will be telephoned by a member of the team, to see if they are interested in taking part in the study. Patients will be sequentially allocated to either the study group or the control group.
Consent will be sought when the patient attends for their ultrasound guided Botox injection. A visual analogue spasticity score will be taken. An initial MRI scan will be obtained of the musculature of the anatomical area. The MRI DICOM data will be uploaded to the ultrasound scanner and anatomical landmarks will be used for fusion, in the MRI fusion patient group. The MRI will then be used as a roadmap to guide the needle for injection into the appropriate muscle. In the control group, the MRI data will not be assessed - the patient will proceed with their injection with ultrasound guidance alone, as per current clinical best practice.
The Botox will be injected into the target musculature, in both the control and MRI fusion groups.
Immediately following on from the ultrasound guided injection and 20-minute recovery period, a subsequent MRI will be performed to confirm that the injectate was within the target muscle. The anatomical coverage and sequences used will be same as the pre-injection MRI.
Approximately 4 weeks post-procedure, a follow up phone call and a repeat spasticity visual analogue score questionnaire will be repeated over the phone. After which, the participant will have ended their time within the study.
- Conditions
- Ultrasound Diagnostic, MRI Fusion
- Being tested
- Ultrasound MRI fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound MRI fusionDiagnostic test
Fused MRI images with direct ultrasound guidance
| Study group | Role | What they receive |
|---|---|---|
| Subjects | All adult patients with capacity and requiring an ultrasound guided Botox injection in the Radiology Department will be invited to take part in the study. Receives: Diagnostic Test: Ultrasound MRI fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Is MRI fusion / ultrasound guided Botox muscle injection more accurate than ultrasound guidance alone?
The MRI signal characteristics of the muscles injected with MRI / ultrasound fusion guidance will be compared with those patients who underwent the procedure with ultrasound alone. The MRI signal is a quantitative measure which can be directly compared between the two groups
Measured: 1 year
Does a patient's muscle stiffness / spasticity improve following image guided Botox injection?
A visual analogue scale will be used pre and post procedure to quantify any changes in spasticity. The scale will be from 1 to 10, with 1 being the least stiffness and 10 being the most stiffness
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start6 Apr 2024
- Primary completion8 Jun 2026
- Study completion8 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ultrasound Diagnostic, MRI FusionStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06091059
- Sponsor's protocol ID
- RL1 878
- Status last verified
- Jul 2026
- First submitted
- 27 Sep 2023
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Burke CJ, Bencardino J, Adler R. The Potential Use of Ultrasound-Magnetic Resonance Imaging Fusion Applications in Musculoskeletal Intervention. J Ultrasound Med. 2017 Jan;36(1):217-224. doi: 10.7863/ultra.16.02024. Epub 2016 Dec 3.
PubMed 27914184
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound - MRI Fusion Guided Injections in Muscles
- ClinicalTrials.gov ID
- NCT06091059
- Acronym / sponsor ID
- RL1 878
- Conditions
- Ultrasound Diagnostic, MRI Fusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS TrustOther government
- Study start
- 6 Apr 2024 (actual)
- Primary completion
- 8 Jun 2026 (actual)
- Study completion
- 8 Jun 2026 (actual)
- First posted
- 19 Oct 2023 (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 is using a new technology of combining MRI and ultrasound images to help guide the injection into the correct muscles.
Combining MRI images with real-time ultrasound images is a new technology which has recently become available. Sometimes ultrasound images can be difficult to interpret, especially when there are problems with stiffness in the muscles. The MRI images create a "road-map" to help understand the ultrasound images at the time of the injection. This may help guide the injection, compared with using ultrasound alone. This technique has not currently been used in muscle injections, therefore we would like to use it as part of a research study.
This study is comparing current standard practice of using ultrasound guidance alone versus ultrasound guidance with an MRI road-map to direct muscle Botox injections.
Detailed description
Potential participants will be identified by referrals for Botox injections within the Radiology. They will be sent a copy of the Information leaflet. A week before the potential participant is due in Radiology, they will be telephoned by a member of the team, to see if they are interested in taking part in the study. Patients will be sequentially allocated to either the study group or the control group.
Consent will be sought when the patient attends for their ultrasound guided Botox injection. A visual analogue spasticity score will be taken. An initial MRI scan will be obtained of the musculature of the anatomical area. The MRI DICOM data will be uploaded to the ultrasound scanner and anatomical landmarks will be used for fusion, in the MRI fusion patient group. The MRI will then be used as a roadmap to guide the needle for injection into the appropriate muscle. In the control group, the MRI data will not be assessed - the patient will proceed with their injection with ultrasound guidance alone, as per current clinical best practice.
The Botox will be injected into the target musculature, in both the control and MRI fusion groups.
Immediately following on from the ultrasound guided injection and 20-minute recovery period, a subsequent MRI will be performed to confirm that the injectate was within the target muscle. The anatomical coverage and sequences used will be same as the pre-injection MRI.
Approximately 4 weeks post-procedure, a follow up phone call and a repeat spasticity visual analogue score questionnaire will be repeated over the phone. After which, the participant will have ended their time within the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects | – | Diagnostic Test: Ultrasound MRI fusionAll adult patients with capacity and requiring an ultrasound guided Botox injection in the Radiology Department will be invited to take part in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- - All adult patients with capacity and requiring an ultrasound guided Botox injection in the Radiology Department will be invited to take part in the study.
Key inclusion criteria (1 listed)
- All adult patients with capacity and requiring an ultrasound guided Botox injection in the Radiology Department will be invited to take part in the study.
Key exclusion criteria (1 listed)
- Children. People who cannot consent. Patients with contra-indications to MRI scanning
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 |
|---|---|---|
| Ultrasound MRI fusionFused MRI images with direct ultrasound guidance | Diagnostic test | Subjects |
Primary outcome
Is MRI fusion / ultrasound guided Botox muscle injection more accurate than ultrasound guidance alone?
Time frame: 1 year
The MRI signal characteristics of the muscles injected with MRI / ultrasound fusion guidance will be compared with those patients who underwent the procedure with ultrasound alone. The MRI signal is a quantitative measure which can be directly compared between the two groups
Does a patient's muscle stiffness / spasticity improve following image guided Botox injection?
Time frame: 1 year
A visual analogue scale will be used pre and post procedure to quantify any changes in spasticity. The scale will be from 1 to 10, with 1 being the least stiffness and 10 being the most stiffness
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 20 Jul 2026.
- Background: PubMed 27914184Burke CJ, Bencardino J, Adler R. The Potential Use of Ultrasound-Magnetic Resonance Imaging Fusion Applications in Musculoskeletal Intervention. J Ultrasound Med. 2017 Jan;36(1):217-224. doi: 10.7863/ultra.16.02024. Epub 2016 Dec 3.
- Individual participant dataSharing planned: No
Related trials for Ultrasound Diagnostic, MRI Fusion
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
RecruitingPhase 1
Robot-Assisted Prostate Biopsy With a Novel Ultrasound Probe
Prostate Cancer (Diagnosis)
Recruiting
Comparing MRI-Ultrasound Fusion and Cognitive-guided Biopsy for the Detection of csPCa: the PROFUSION Trial
Prostate Cancer
Recruiting
Ipsilateral Versus Bilateral Systematic Biopsy Combined With MRI/Ultrasound Cognitive Fusion Targeted Biopsy for Prostate Cancer Diagnosis
Prostate Cancer
Recruiting
TENS During Transperineal Prostate Biopsy
Prostate Cancer (Diagnosis), Prostate Biopsy
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 Diagnostic, MRI Fusion, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust at 1 site in United Kingdom.
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 1 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 20 Jul 2026. 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 United Kingdom. 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?
Is MRI fusion / ultrasound guided Botox muscle injection more accurate than ultrasound guidance alone? (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06091059, which also lists 1 linked publication.
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 20 Jul 2026.