Ultrasound - MRI Fusion Guided Injections in Muscles
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Shropshire
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Oswestry, Shropshire, United Kingdom, SY10 7AG
- The Robert Jones and Agnes hunt
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
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Fused MRI images with direct ultrasound guidance
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Is MRI fusion / ultrasound guided Botox muscle injection more accurate than ultrasound guidance alone?
Time Frame: 1 year
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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
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1 year
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Does a patient's muscle stiffness / spasticity improve following image guided Botox injection?
Time Frame: 1 year
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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
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1 year
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RL1 878
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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