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	https://doi.org/10.1186/ISRCTN13668166
Protocol serial number	2001/RUO/04
Sponsor	Queen Margaret University (UK)
Funder	Chief Scientist Office of the Scottish Executive Health Department (UK)

Submission date: 03/10/2008
Registration date: 12/11/2008
Last edited: 05/03/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Colin Thompson
Scientific

School of Health Sciences
Queen Margaret University
Edinburgh
EH21 6UU
United Kingdom

Email	cthomson@qmu.ac.uk

Study information

Primary study design	Interventional
Study design	Incremental cost-effectiveness analysis and single-blind pragmatic randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	A double-blind multi-centre randomised controlled trial to investigate the effectiveness of methylprednisolone injections in the treatment of Morton's neuroma
Study acronym	MoRTISE
Study objectives	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(s)	Lothian Research Ethics Committee (Orthopaedic surgery/surgery Research ethics sub-committee), 23/11/2000, ref: LREC/2000/5/31
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Methylprednisolone
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.
Key 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.
Completion date	31/07/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	150
Key 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.
Key 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
Date of first enrolment	01/08/2003
Date of final enrolment	31/07/2005

Locations

Countries of recruitment

United Kingdom
Scotland

Study participating centre

Queen Margaret University

Edinburgh
EH21 6UU
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2013		Yes	No
Results article	economic evaluation results	25/02/2015		Yes	No