NCT03046108

Blind and Ultrasound Guided Injection in Morton Neuroma

Comparison Between Blind and Ultrasound Guided Injection in Morton Neuroma

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Complejo Hospitalario Universitario de Granada · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Morton Neuroma

Interventions

Type	Name	Description
DEVICE	blind injection of Morton neuroma	Introduction of a needle based in anatomical landmark
DRUG	blind injection of Mepivacaine	blind injection of 1 cc of Mepivacaine Normon 2% ®
DRUG	blind injection of Triamcinolone	blind injection of 40 mg of triamcinolone (trigon depot ®)
DEVICE	ultrasound guided injection	Introduction of a needle based guided by ultrasound
DRUG	guided injection of mepivacaine	ultrasound guided injection of 1 cc of Mepivacaine Normon 2% ®
DRUG	guided injection of Triamcinolone	ultrasound guided injection of 40 mg of triamcinolone (trigon depot ®)

Timeline

• Start date: 2016-01-01
• Primary completion: 2018-08-01
• Completion: 2018-08-01
• First posted: 2017-02-08
• Last updated: 2017-10-18

Locations

1 site across 1 country: Spain