Manipulation Versus Steroid Injection in the Treatment of Morton's Neuroma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Visual analogue pain scale
研究概览
简要总结
This study compares manipulative therapy to steroid injection in the treatment of Morton's Neuroma.
详细描述
The aim of this study is to establish whether manipulative therapy is an effective treatment for Morton's neuroma, a nerve entrapment in the foot. Steroid injection is the current gold standard conservative treatment for this condition. Therefore, a subject group shall be compared to a steroid injection intervention group. Outcomes will be compared using visual analogue pain scales -VAS, Foot Function Index questionnaires and algometric pressure threshold testing. An improvement in the manipulation group VAS of 20mm above the injection group shall be considered as the minimum worthwhile change as this has been identified as the minimum clinically important difference in pain between treatment groups in visual analogue pain scales.
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 diagnosis of morton's neuroma
- •over 18 years of age
- •presenting VAS score > 30mm
排除标准
- •diabetes,
- •rheumatoid arthritis
- •fibromyalgia.
- •Those currently taking Statins or analgesics
- •previous neuroma surgery
研究组 & 干预措施
steroid injection
1 injection of 1mL methylprednisolone [40mg]with 1 mL 2% lignocaine
干预措施: methylprednisolone (Drug)
manual manipulation
weekly manipulations to the metatarsophalangeal joints of the forefoot for 6 weeks
干预措施: manual manipulation (Procedure)
结局指标
主要结局
Visual analogue pain scale
时间窗: pre treatment at each clinic visit and then 3,6,9 and 12 months
Measuring changes in self reported pain over time. 100mm scale with anchored prompts of "no pain" at 0mm and "worst pain ever" at 100mm
次要结局
- Algometric pressure threshold meter(pre treatment at each clinic visit and then 3,6,9 and 12 months)
