Ultrasound MRI fusion guided Botox injections
Research type
Research Study
Full title
Ultrasound - MRI fusion guided Botox muscle injections
IRAS ID
330537
Contact name
Naomi Winn
Contact email
Sponsor organisation
The Robert Jones and Agnes Hunt Orthopaedic Hospital
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Ultrasound fusion is a technology which has recently become available for mainstream clinical use. It allows overlay of real time ultrasound images on previously acquired MRI or CT data sets, to help with anatomical localisation. To date, this has been extensively used in guiding prostate biopsies. There is limited data of its use in the musculoskeletal system. Patients often require ultrasound guided injections as part of their clinical care. Sometimes it can be difficult to delineate the muscles on ultrasound, to target the injection. This research proposal aims to acquire MRI images of a patient’s muscles for fusion. The target patient group is people requiring ultrasound guided muscle Botox injections to help reduce muscle stiffness. These patients often have muscle anatomy which is difficult to delineate on conventional ultrasound alone. The study will involve two additional MRI scans, to be performed during the same hospital visit as the ultrasound guided Botox injection. The over-laid MRI images will be used to help target ultrasound guided Botox injections, as part of routine clinical care. Patients will also complete a questionnaire on their muscle stiffness (or spasticity in medical terminology) before and after the injection procedure. The MRI scan after the procedure will be used to determine the technical accuracy of the injection. Patients will be consecutively allocated to the control group or MRI fusion group. The control group will undergo their injection with ultrasound guidance alone, as per the current clinical standard. The MRI fusion group will undergo their injection with the additional MRI road-map to guide the injection. The primary outcome measure is to compare the MRI signal intensity in the muscle groups between the study group and controls. The secondary outcome measure is the visual analogue spasticity score.
REC name
South East Scotland REC 02
REC reference
24/SS/0018
Date of REC Opinion
20 Mar 2024
REC opinion
Further Information Favourable Opinion