A Randomised Controlled Trial to Compare the Clinical Effectiveness of Lower Extremity Manipulation to That of Steroid Injection in the Treatment of Morton's Neuroma
试验速览
- 阶段
- 不适用
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Visual analogue pain scale
研究概览
简要总结
The aim of this study is to establish which of two treatment options is the preferred intervention in the treatment of Morton's Neuroma.
A randomised controlled trial shall be performed. Steroid injection is the current gold standard conservative treatment for this condition. Therefore, manipulation shall be compared to a control group receiving a steroid injection in an equality randomised controlled trial.
Outcomes will be compared using visual analogue pain scales (VAS), The Manchester-Oxford Foot Questionnaire (MOXFQ), The Foot and Ankle Ability Measure (FAAM), the SF-36 quality of life questionnaire and algometric pressure threshold testing. An improvement in either groups' VAS of 20mm above the other 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.
There is limited research evidence to support the management of Morton's neuroma with steroid injection although its efficacy has only been demonstrated in the short term.
详细描述
Proposed Randomised Single Blind Study Aims and objectives The aim of this study is to establish which of two treatment options is the preferred intervention in the treatment of Morton's Neuroma.
Objectives. A systematic review of the literature shall be undertaken in order to inform the researchers. The Pressure Threshold Meter shall be validated for use in the foot.
A randomised controlled trial shall be performed. Steroid injection is the current gold standard conservative treatment for this condition. Therefore, manipulation shall be compared to a control group receiving a steroid injection in an equality randomised controlled trial.
Outcomes will be compared using visual analogue pain scales (VAS), The Manchester-Oxford Foot Questionnaire (MOXFQ), The Foot and Ankle Ability Measure (FAAM), the SF-36 quality of life questionnaire and algometric pressure threshold testing.
An improvement in either group VAS of 20mm above the other 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 (Thomson et al. 2013). The primary question will ask whether manipulation is beneficial in the treatment of MN. Secondary questions will be addressed, including, are the benefits of manipulation for Morton's neuroma long lasting, and do they out-perform the current conservative interventions at three months, six months and one year. Is PTM an accurate and reliable measurement tool for foot pain? Furthermore, does manipulation result in changes to mechanical loading during gait as seen on high resolution walkway analysis?
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
- •Inclusion criteria shall be any positive clinical sign together with a positive diagnostic ultrasound giving rise to a diagnosis of Morton's neuroma/plantar digital neuritis.
- •A VAS score of no less than 25/100 will also be required.
- •All subjects must be over 18 years of age and able to offer informed consent.
排除标准
- •Absolute exclusion criteria will include Rheumatoid Arthritis, recent (less than 3 months) fracture to the affected foot, peripheral neuropathy, localised infection, pregnancy, allergy to Methylprednisolone.
- •Allergy to local anaesthetic.
- •Further exclusion criteria include Active infection
- •Diabetes mellitus
- •Ulcerative colitis
- •Diverticulitis
- •Hypothyroidism
- •Osteoporosis
- •Renal impairment
- •Hepatic impairment and Coagulation disorders.
研究组 & 干预措施
manipulation
Those in the manipulation group shall have the lesser MTPJs of the affected foot manually manipulated using a high velocity, low amplitude thrust technique. They will be asked to return once each week for a further five weeks. At each visit the VAS and PTM measurements shall be repeated, as will the manual manipulation. They shall also be asked to return for a review in the sixth week.
干预措施: Manual manipulation (Other)
Steroid
Those randomised to the steroid group shall receive a single injection of 1 mL methylprednisolone [40 mg] and 1 mL 2% lignocaine. They shall then be asked to return for review in six weeks. A second injection may be offered at this point if clinically indicated.
干预措施: methylprednisolone (Drug)
结局指标
主要结局
Visual analogue pain scale
时间窗: baseline then every 3 months until one year after randomisation
Assessing change from baseline to one year in recorded visual analogue pain scales
次要结局
- SF-36 Questionnaire(every 3 months until one year after randomisation)
- Algometric pressure threshold testing(every 3 months until one year after randomisation)
- Manchester - Oxford Foot Questionnaire(every 3 months until one year after randomisation)
- The Foot and Ankle Ability Measure(every 3 months until one year after randomisation)
研究者
David Cashley
Mr David Cashley
Queen Margaret University