Comparison Between Blind and Ultrasound Guided Injection in Morton Neuroma
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pain (VAS score)
研究概览
简要总结
The aim of this work trial is to compare the effectiveness of blind and ultrasound guided injection for Morton neuroma in order to determine which is more appropriate as the initial procedure in conservative treatment
详细描述
This is a evaluator-blinded randomized trial. The final sample size has been calculated to be 100 patients. 50 of group 1 are going to be injected by an experimented orthopaedic surgeon based on anatomic landmark. 50 of group 2 are going to be injected by an experimented musculoskeletal radiologist under ultrasound guidance.
The inclusion criteria are clinical suspicion of Morton neuroma confirmed in ultrasound scan. Included patients are assessed clinically by VAS score, the Manchester Foot Pain and Disability Schedule (MFPDS), and a generic quality-of-life instrument, the EQ-5D.
Injection includes 1 cc of 2% mepivacaine and 40 mg of triamcinolone in each web space with Morton Neuroma. According evolution until 4 injections were allowed the first 2 months of follow-up, Follow up was performed by phone calls and/or scheduled consultations at 15 days, 1 month, 45 days, 2 months, 3 months, 6 months and 1 year.
Statistical analysis was performed by unpaired Student's t test
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Clinical suspicion of Morton neuroma confirmed in ultrasound scan
- •Symptoms present more than six months
- •The thickness of the nerve must be at least 2 mm in short axis and at least 5 mm in the longitudinal axis.
排除标准
- •Contraindication for the use of corticosteroids or local anesthetics
- •Presence of inflammatory arthropathy or neuropathy
- •Skin lesions in the area
- •diabetes mellitus
- •Infiltration or previous surgery in the area
- •Refusal to participate in the study
研究组 & 干预措施
blind injection of Morton neuroma
Percoutaneous blind injection in Morton neuroma by subcutaneous needle group 1 are going to be injected by an experimented orthopaedic surgeon based on anatomic landmark. There is no internal control of the needle placement.
Mixture of 1 cc of 2% mepivacaine (Mepivacaina Normon 2%® )+ 40 mg of triamcinolone (Trigon Depot®) in each of the web spaces affected with Morton neuroma is injected.
Up to 4 injections are allow in the first three months of follow-up
干预措施: blind injection of Morton neuroma (Device)
blind injection of Morton neuroma
Percoutaneous blind injection in Morton neuroma by subcutaneous needle group 1 are going to be injected by an experimented orthopaedic surgeon based on anatomic landmark. There is no internal control of the needle placement.
Mixture of 1 cc of 2% mepivacaine (Mepivacaina Normon 2%® )+ 40 mg of triamcinolone (Trigon Depot®) in each of the web spaces affected with Morton neuroma is injected.
Up to 4 injections are allow in the first three months of follow-up
干预措施: blind injection of Mepivacaine (Drug)
blind injection of Morton neuroma
Percoutaneous blind injection in Morton neuroma by subcutaneous needle group 1 are going to be injected by an experimented orthopaedic surgeon based on anatomic landmark. There is no internal control of the needle placement.
Mixture of 1 cc of 2% mepivacaine (Mepivacaina Normon 2%® )+ 40 mg of triamcinolone (Trigon Depot®) in each of the web spaces affected with Morton neuroma is injected.
Up to 4 injections are allow in the first three months of follow-up
干预措施: blind injection of Triamcinolone (Drug)
blind injection of Mepivacaine
1 cc of 2% mepivacaine (Mepivacaina Normon 2%® )+ 40 mg of triamcinolone (Trigon Depot®) in each of the web spaces affected with Morton neuroma is injected.
Up to 4 injections are allow in the first three months of follow-up
干预措施: blind injection of Morton neuroma (Device)
blind injection of Mepivacaine
1 cc of 2% mepivacaine (Mepivacaina Normon 2%® )+ 40 mg of triamcinolone (Trigon Depot®) in each of the web spaces affected with Morton neuroma is injected.
Up to 4 injections are allow in the first three months of follow-up
干预措施: blind injection of Mepivacaine (Drug)
blind injection of Mepivacaine
1 cc of 2% mepivacaine (Mepivacaina Normon 2%® )+ 40 mg of triamcinolone (Trigon Depot®) in each of the web spaces affected with Morton neuroma is injected.
Up to 4 injections are allow in the first three months of follow-up
干预措施: blind injection of Triamcinolone (Drug)
blind injection of Triamcinolone
40 mg of triamcinolone (Trigon Depot®) in each of the web spaces affected with Morton neuroma is injected. Up to 4 injections are allow in the first three months of follow-up
干预措施: blind injection of Morton neuroma (Device)
blind injection of Triamcinolone
40 mg of triamcinolone (Trigon Depot®) in each of the web spaces affected with Morton neuroma is injected. Up to 4 injections are allow in the first three months of follow-up
干预措施: blind injection of Mepivacaine (Drug)
blind injection of Triamcinolone
40 mg of triamcinolone (Trigon Depot®) in each of the web spaces affected with Morton neuroma is injected. Up to 4 injections are allow in the first three months of follow-up
干预措施: blind injection of Triamcinolone (Drug)
ultrasound guided injection
US guided injection in Morton neuroma by subcutaneous needle. group 2 are going to be injected by an experimented musculoskeletal radiologist under ultrasound guidance. There is internal control of needle placement by ultrasound.
干预措施: ultrasound guided injection (Device)
ultrasound guided injection
US guided injection in Morton neuroma by subcutaneous needle. group 2 are going to be injected by an experimented musculoskeletal radiologist under ultrasound guidance. There is internal control of needle placement by ultrasound.
干预措施: guided injection of mepivacaine (Drug)
ultrasound guided injection
US guided injection in Morton neuroma by subcutaneous needle. group 2 are going to be injected by an experimented musculoskeletal radiologist under ultrasound guidance. There is internal control of needle placement by ultrasound.
干预措施: guided injection of Triamcinolone (Drug)
guided injection of mepivacaine
2% mepivacaine (Mepivacaina Normon 2%® ) in each of the web spaces affected with Morton neuroma is injected.
Up to 4 injections are allow in the first three months of follow-up
干预措施: ultrasound guided injection (Device)
guided injection of mepivacaine
2% mepivacaine (Mepivacaina Normon 2%® ) in each of the web spaces affected with Morton neuroma is injected.
Up to 4 injections are allow in the first three months of follow-up
干预措施: guided injection of mepivacaine (Drug)
guided injection of mepivacaine
2% mepivacaine (Mepivacaina Normon 2%® ) in each of the web spaces affected with Morton neuroma is injected.
Up to 4 injections are allow in the first three months of follow-up
干预措施: guided injection of Triamcinolone (Drug)
guided injection of Triamcinolone
40 mg of triamcinolone (Trigon Depot®) in each of the web spaces affected with Morton neuroma is injected. Up to 4 injections are allow in the first three months of follow-up
干预措施: ultrasound guided injection (Device)
guided injection of Triamcinolone
40 mg of triamcinolone (Trigon Depot®) in each of the web spaces affected with Morton neuroma is injected. Up to 4 injections are allow in the first three months of follow-up
干预措施: guided injection of mepivacaine (Drug)
guided injection of Triamcinolone
40 mg of triamcinolone (Trigon Depot®) in each of the web spaces affected with Morton neuroma is injected. Up to 4 injections are allow in the first three months of follow-up
干预措施: guided injection of Triamcinolone (Drug)
结局指标
主要结局
Pain (VAS score)
时间窗: 1 year
Pain relieve
次要结局
- Manchester foot pain and disability index(1 year)
- Generic quality-of-life instrument, the EQ-5D(1 year)
研究者
FERNANDO RUIZ SANTIAGO
PhD, section chief musculoskeletal radiology
Complejo Hospitalario Universitario de Granada