Morton Neuroma
Conditions
Brief summary
The aim of this work trial is to compare the effectiveness of blind and ultrasound guided injection for Morton neuroma in order to determine which is more appropriate as the initial procedure in conservative treatment
Detailed description
This is a evaluator-blinded randomized trial. The final sample size has been calculated to be 100 patients. 50 of group 1 are going to be injected by an experimented orthopaedic surgeon based on anatomic landmark. 50 of group 2 are going to be injected by an experimented musculoskeletal radiologist under ultrasound guidance. The inclusion criteria are clinical suspicion of Morton neuroma confirmed in ultrasound scan. Included patients are assessed clinically by VAS score, the Manchester Foot Pain and Disability Schedule (MFPDS), and a generic quality-of-life instrument, the EQ-5D. Injection includes 1 cc of 2% mepivacaine and 40 mg of triamcinolone in each web space with Morton Neuroma. According evolution until 4 injections were allowed the first 2 months of follow-up, Follow up was performed by phone calls and/or scheduled consultations at 15 days, 1 month, 45 days, 2 months, 3 months, 6 months and 1 year. Statistical analysis was performed by unpaired Student's t test
Interventions
DEVICEblind injection of Morton neuroma
Introduction of a needle based in anatomical landmark
DRUGblind injection of Mepivacaine
blind injection of 1 cc of Mepivacaine Normon 2% ®
DRUGblind injection of Triamcinolone
blind injection of 40 mg of triamcinolone (trigon depot ®)
Introduction of a needle based guided by ultrasound
DRUGguided injection of mepivacaine
ultrasound guided injection of 1 cc of Mepivacaine Normon 2% ®
DRUGguided injection of Triamcinolone
ultrasound guided injection of 40 mg of triamcinolone (trigon depot ®)
Sponsors
Complejo Hospitalario Universitario de Granada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical suspicion of Morton neuroma confirmed in ultrasound scan * Symptoms present more than six months * The thickness of the nerve must be at least 2 mm in short axis and at least 5 mm in the longitudinal axis.
Exclusion criteria
* Contraindication for the use of corticosteroids or local anesthetics * Presence of inflammatory arthropathy or neuropathy * Skin lesions in the area * diabetes mellitus * Infiltration or previous surgery in the area * Refusal to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain (VAS score) | 1 year | Pain relieve |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Manchester foot pain and disability index | 1 year | Disability measurement |
| Generic quality-of-life instrument, the EQ-5D | 1 year | Quality of life measurement |
Countries
Spain
Contacts
Primary ContactPABLO TOMAS MUÑOZ, PhD
Backup ContactANA MARIA DEL VALLE DIAZ DE LA GUARDIA, MD
Outcome results
None listed