Morton's neuroma Nervous System Diseases Mononeuropathies of lower limb
Conditions
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
Sponsors
Queen Margaret University (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United Kingdom
Outcome results
None listed