Morton's neuroma: Manipulation versus steroid injection -Version 3.0.1

  • Research type

    Research Study

  • Full title

    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: A pragmatic study

  • IRAS ID

    129586

  • Contact name

    David Cashley

  • Contact email

    dcashley@qmu.ac.uk

  • Sponsor organisation

    Queen Margaret University

  • Clinicaltrials.gov Identifier

    NCT02304094

  • Duration of Study in the UK

    2 years, 2 months, 25 days

  • Research summary

    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. To date we have no evidence of any conservative treatment working well for this condition in the long term. This study will investigate whether manipulation offers a better long term result than a steroid injection.
    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.

  • REC name

    South East Scotland REC 01

  • REC reference

    15/SS/0099

  • Date of REC Opinion

    15 Jun 2015

  • REC opinion

    Favourable Opinion