Ultrasound - MRI Fusion Guided Injections in Muscles
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Is MRI fusion / ultrasound guided Botox muscle injection more accurate than ultrasound guidance alone?
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Children. People who cannot consent. Patients with contra-indications to MRI scanning
研究组 & 干预措施
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.
干预措施: Ultrasound MRI fusion (Diagnostic Test)
结局指标
主要结局
Is MRI fusion / ultrasound guided Botox muscle injection more accurate than ultrasound guidance alone?
时间窗: 1 year
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
Does a patient's muscle stiffness / spasticity improve following image guided Botox injection?
时间窗: 1 year
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
次要结局
未报告次要终点