Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-26 @ 3:36 AM
Study NCT ID:
NCT06091059
Status:
RECRUITING
Last Update Posted:
2024-04-11
First Post:
2023-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound - MRI Fusion Guided Injections in Muscles
Sponsor:
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
Organization:
Study Overview
Official Title:
Ultrasound - MRI Fusion Guided Injections in Muscles
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: