Ultrasound - MRI Fusion Guided Injections in Muscles

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Ultrasound - MRI Fusion Guided Injections in Muscles

Conditions
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Ultrasound Diagnostic, MRI Fusion

Intervention / Treatment
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* Diagnostic Test: Ultrasound MRI fusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Children. People who cannot consent. Patients with contra-indications to MRI scanning

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects<br>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. | Diagnostic Test: Ultrasound MRI fusion<br>* Fused MRI images with direct ultrasound guidance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 1 year |