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临床试验/NCT05707572
NCT05707572已完成不适用

Manipulation Versus Steroid Injection in the Treatment of Morton's Neuroma

Dundee Podiatry Clinic1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2014年9月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

1 injection of 1mL methylprednisolone [40mg]with 1 mL 2% lignocaine

干预措施: methylprednisolone (Drug)

manual manipulation

Experimental

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)

研究者

发起方
Dundee Podiatry Clinic
申办方类型
Other
责任方
Sponsor

研究点 (1)

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