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A double-blind multi-centre randomised controlled trial to investigate the effectiveness of methylprednisolone injections in the treatment of Morton's neuroma
ISRCTN ISRCTN13668166
DOI 10.1186/ISRCTN13668166
ClinicalTrials.gov identifier
EudraCT number
Public title A double-blind multi-centre randomised controlled trial to investigate the effectiveness of methylprednisolone injections in the treatment of Morton's neuroma
Scientific title
Acronym MoRTISE
Serial number at source 2001/RUO/04
Study hypothesis The trial is designed primarily to address the question: is local injection of steroid (methylprednisolone) an effective treatment for Morton's neuroma? Thus we seek to test the following null hypothesis: that steroid injections are as effective as anaesthetic injections for the pain and the effects of pain associated with Morton's neuroma.
Lay summary Not provided at time of registration
Ethics approval Lothian Research Ethics Committee (Orthopaedic surgery/surgery Research ethics sub-committee) gave approval on the 23rd November 2000 (ref: LREC/2000/5/31)
Study design Incremental cost-effectiveness analysis and single blind pragmatic randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Morton's neuroma
Participants - inclusion criteria All patients (adult, either sex) referred to outpatient clinics at The Royal Infirmary Edinburgh (RIE), St John's Hospital Livingston and Queen Margaret University College (QMUC) with a diagnosis of Morton's neuroma, confirmed by a diagnostic ultrasound scan, will be considered for inclusion in the trial.
Participants - exclusion criteria 1. Contraindications to methylprednisolone or lignocaine such as pregnancy, breast-feeding or peripheral vascular disease
2. Communication difficulties as judged by the recruiting clinician
3. Received a recent injection of steroid for Morton's neuroma
Anticipated start date 01/08/2003
Anticipated end date 31/07/2005
Status of trial Completed
Patient information material
Target number of participants 150 patients (75 in each group)
Interventions Participants will be allocated to receive steroid and anaesthetic (injection of 1 ml methylprednisolone and 1 ml 2% lignocaine) or just anaesthetic (2 ml of 1% lignocaine). All ultrasound examinations and injections will be performed by the same musculoskeletal radiologist using an ATL HDI 5000 (Seattle, Washington) with a 7-12MHz transducer. Neuroma will be injected by a plantar approach. Patients will receive only a single injection and patints will be reviewed clinically after 3 months.
Primary outcome measure(s) 1. Patient completed booklet of outcome measures, comprehensive yet brief, will cover the following domains:
1.1. Foot Health Status - the Foot Thermometer, a validated 10 cm visual analogue scale of foot health, will be the primary outcome measure. A validated questionnaire-based measure of foot health status will complement it.
1.2. Functional Disability - the Manchester Foot Pain and Disability Schedule has been validated for use as a measure of disability specifically associated with foot pain
1.3. Pain - the Multidimensional Affect and Pain Survey (MAPS) is a widely validated questionnaire developed from cluster analysis of common descriptors for pain and its effects. It covers three dimensions: pain as a sensory experience; suffering associated with pain; and uniquely, for this type of measurement tool, general well-being in the presence of pain.
1.4. General Health Status - the EuroQol, a single validated index for describing and valuing health states. It consists of five items - mobility, self-care, usual activities, pain or discomfort, and anxiety or depression - and a visual analogue scale of global health status.
2. Need for surgical excision of the digital nerve, based on explicit criteria
3. The size of the neuroma, as determined by ultrasonic scan

All measured at 1 month, 3 months and 12 months.
Secondary outcome measure(s) Patients will receive essentially the same outcome booklets as above 1, 3 and 12 months after treatment. In the case of non-response to postal questionnaires, the research secretary will send out written reminders to patients after 1 and 2 weeks: the research secretary will also contact patients by telephone at the time of posting the second reminder. Additional clinical information, such as adverse events, will be documented by the trial clinical co-ordinator at the clinical review appointment after four months. This information will be forwarded, by post, directly to the research secretary as part of the usual routine of clinical documentation.
Sources of funding Chief Scientist Office of the Scottish Executive Health Department (UK)
Trial website
Publications 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23636185
Contact name Dr  Colin  Thompson
  Address School of Health Sciences
Queen Margaret University
  City/town Edinburgh
  Zip/Postcode EH21 6UU
  Country United Kingdom
  Email cthomson@qmu.ac.uk
Sponsor Queen Margaret University (UK)
  Address Queen Margaret University Drive
  City/town Edinburgh
  Zip/Postcode EH21 6UU
  Country United Kingdom
  Email jtait@qmu.ac.uk
  Sponsor website: http://www.qmu.ac.uk/
Date applied 03/10/2008
Last edited 01/07/2013
Date ISRCTN assigned 12/11/2008
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