Ultrasound - MRI Fusion Guided Injections in Muscles

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-06

Study Completion Date

2025-05-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Influence of Adding High Power Pain Threshold Ultrasound to Traditional Therapy on Axioappendicular Muscles Amplitude and Fatigue in Mechanical Neck Pain Randomized Clinical Trials

NCT05540093

Neck Pain

COMPLETED NA

Effectiveness of TU and MRT to Release Trigger Points to Increase RoM and Pain Relief in Upper TT

NCT05854004

Pain

UNKNOWN NA

Evaluation of a Novel Class of Objective Myofascial Pain Assessments

NCT05793086

Myofascial Pain Trigger Point Pain, Myofascial

ACTIVE_NOT_RECRUITING

The Effects of Ultrasound-guided PRF Versus DN in Myofascial Pain Patients

NCT06851000

Myofascial Pain

NOT_YET_RECRUITING NA

Ultrasound-guided Fascial Release Injection for Myofascial Pain Syndrome in the Upper Trapezius Muscle

NCT03867604

Myofascial Pain Syndrome

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ultrasound Diagnostic, MRI Fusion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Ultrasound MRI fusion

Intervention Type DIAGNOSTIC_TEST

Fused MRI images with direct ultrasound guidance

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.