Ultrasound - MRI Fusion Guided Injections in Muscles

NCT06091059 | Recruiting

• 1 other identifier: RL1 878
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Ultrasound Diagnostic, MRI Fusion

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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

Interventions

Ultrasound MRI fusion DIAGNOSTIC_TEST

Fused MRI images with direct ultrasound guidance

Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Children. People who cannot consent. Patients with contra-indications to MRI scanning

Sponsors & Collaborators

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

Study Sites (1)

The Robert Jones and Agnes hunt

Oswestry, Shropshire, SY10 7AG, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 27914184 BACKGROUND

Central Study Contacts

Julie Steen

CONTACT

01691 404418; julie.steen@nhs.net

Naomi Winn

CONTACT

01691 404569; naomi.winn@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 19, 2023
• Study Start: April 6, 2024
• Primary Completion: April 6, 2025
• Study Completion: May 6, 2025
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)