Condition category
Nervous System Diseases
Date applied
03/10/2008
Date assigned
12/11/2008
Last edited
05/03/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Colin Thompson

ORCID ID

Contact details

School of Health Sciences
Queen Margaret University
Edinburgh
EH21 6UU
United Kingdom
-
cthomson@qmu.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2001/RUO/04

Study information

Scientific title

A double-blind multi-centre randomised controlled trial to investigate the effectiveness of methylprednisolone injections in the treatment of Morton's neuroma

Acronym

MoRTISE

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.

Ethics approval

Lothian Research Ethics Committee (Orthopaedic surgery/surgery Research ethics sub-committee), 23/11/2000, ref: LREC/2000/5/31

Study design

Incremental cost-effectiveness analysis and single-blind pragmatic randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Morton's neuroma

Intervention

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.

Intervention type

Drug

Phase

Not Applicable

Drug names

Methylprednisolone

Primary outcome measures

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 measures

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.

Overall trial start date

01/08/2003

Overall trial end date

31/07/2005

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150 patients (75 in each group)

Participant 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

Recruitment start date

01/08/2003

Recruitment end date

31/07/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Queen Margaret University
Edinburgh
EH21 6UU
United Kingdom

Sponsor information

Organisation

Queen Margaret University (UK)

Sponsor details

Queen Margaret University Drive
Edinburgh
EH21 6UU
United Kingdom
-
jtait@qmu.ac.uk

Sponsor type

University/education

Website

http://www.qmu.ac.uk/

Funders

Funder type

Government

Funder name

Chief Scientist Office of the Scottish Executive Health Department (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23636185
2015 economic evaluation results in: http://www.ncbi.nlm.nih.gov/pubmed/25737743

Publication citations

  1. Results

    Thomson CE, Beggs I, Martin DJ, McMillan D, Edwards RT, Russell D, Yeo ST, Russell IT, Gibson JN, Methylprednisolone injections for the treatment of Morton neuroma: a patient-blinded randomized trial., J Bone Joint Surg Am, 2013, 95, 9, 790-8, S1, doi: 10.2106/JBJS.I.01780.

  2. Results

    Edwards RT, Yeo ST, Russell D, Thomson CE, Beggs I, Gibson JN, McMillan D, Martin DJ, Russell IT, Cost-effectiveness of steroid (methylprednisolone) injections versus anaesthetic alone for the treatment of Morton's neuroma: economic evaluation alongside a randomised controlled trial (MortISE trial), J Foot Ankle Res, 2015 , doi: 10.1186/s13047-015-0064-y.

Additional files

Editorial Notes