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: Recruiting
• Conditions: Ultrasound Diagnostic, MRI Fusion
• Intervention / Treatment: Diagnostic test: Ultrasound MRI fusion

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: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Naomi Winn; Phone Number: 01691 404569; Email: naomi.winn@nhs.net
• Study Contact Backup: Name: Julie Steen; Phone Number: 01691 404418; Email: julie.steen@nhs.net

Study Locations

• United Kingdom
  • Shropshire
    • Oswestry, Shropshire, United Kingdom, SY10 7AG
      • Recruiting
      • The Robert Jones and Agnes hunt
      • Contact: Julie Steen; Phone Number: +441691404418; Email: julie.steen@nhs.net
      • Principal Investigator: Naomi Winn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

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?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: Ultrasound MRI fusion; Fused MRI images with direct ultrasound guidance

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Estimated): April 6, 2024
• Primary Completion (Estimated): April 6, 2025
• Study Completion (Estimated): May 6, 2025

Study Registration Dates

• First Submitted: September 27, 2023
• First Submitted That Met QC Criteria: October 13, 2023
• First Posted (Actual): October 19, 2023

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

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)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No