drugset / Trial / NCT02304094

Morton's Neuroma: Manipulation Versus Steroid Injection

NCT02304094

Unknown 64 enrolled Queen Margaret University
RandomizedParallel-groupSingle-blindTreatment

Summary

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.

Timeline

Start
2015-10
Primary completion
2016-04
Completion
2017-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Methylprednisolone Other / unclassified 40 mg
Background Lidocaine Other / unclassified 1 ml
Background Lidocaine Other / unclassified 2 %

Indications