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 |
| Secondary identifying numbers | 2001/RUO/04 |
- 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
Scientific
School of Health Sciences
Queen Margaret University
Edinburgh
EH21 6UU
United Kingdom
| cthomson@qmu.ac.uk |
Study information
| Study design | Incremental cost-effectiveness analysis and single-blind pragmatic randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Methylprednisolone |
| Primary outcome measure | 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 study start date | 01/08/2003 |
| Completion date | 31/07/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 150 patients (75 in each group) |
| 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
- Scotland
- United Kingdom
Study participating centre
Queen Margaret University
Edinburgh
EH21 6UU
United Kingdom
EH21 6UU
United Kingdom
Sponsor information
Queen Margaret University (UK)
University/education
University/education
Queen Margaret University Drive
Edinburgh
EH21 6UU
Scotland
United Kingdom
| jtait@qmu.ac.uk | |
| Website | http://www.qmu.ac.uk/ |
"ROR" |
https://ror.org/002g3cb31 |
Funders
Funder type
Government
Chief Scientist Office of the Scottish Executive Health Department (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
