A Phase 4 interventional study of blind injection of Morton neuroma and blind injection of Mepivacaine in Morton Neuroma, sponsored by Complejo Hospitalario Universitario de Granada. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-18.
Sponsored by Complejo Hospitalario Universitario de Granada · Phase 4, Interventional, and Treatment
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
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
70 studies on the registry are indexed under Neuroma; 12 are open to participants now.
This study's planned enrollment of 100 is above the median of 33 across 49 interventional studies indexed under Neuroma.
Browse Neuroma studies →Complejo Hospitalario Universitario de Granada is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Percoutaneous blind injection in Morton neuroma by subcutaneous needle group 1 are going to be injected by an experimented orthopaedic surgeon based on anatomic landmark. There is no internal control of the needle placement. Mixture of 1 cc of 2% mepivacaine (Mepivacaina Normon 2%® )+ 40 mg of triamcinolone (Trigon Depot®) in each of the web spaces affected with Morton neuroma is injected. Up to 4 injections are allow in the first three months of follow-up
Device: blind injection of Morton neuroma · Drug: blind injection of Mepivacaine · Drug: blind injection of Triamcinolone
1 cc of 2% mepivacaine (Mepivacaina Normon 2%® )+ 40 mg of triamcinolone (Trigon Depot®) in each of the web spaces affected with Morton neuroma is injected. Up to 4 injections are allow in the first three months of follow-up
Device: blind injection of Morton neuroma · Drug: blind injection of Mepivacaine · Drug: blind injection of Triamcinolone
40 mg of triamcinolone (Trigon Depot®) in each of the web spaces affected with Morton neuroma is injected. Up to 4 injections are allow in the first three months of follow-up
Device: blind injection of Morton neuroma · Drug: blind injection of Mepivacaine · Drug: blind injection of Triamcinolone
US guided injection in Morton neuroma by subcutaneous needle. group 2 are going to be injected by an experimented musculoskeletal radiologist under ultrasound guidance. There is internal control of needle placement by ultrasound.
Device: ultrasound guided injection · Drug: guided injection of mepivacaine · Drug: guided injection of Triamcinolone
2% mepivacaine (Mepivacaina Normon 2%® ) in each of the web spaces affected with Morton neuroma is injected. Up to 4 injections are allow in the first three months of follow-up
Device: ultrasound guided injection · Drug: guided injection of mepivacaine · Drug: guided injection of Triamcinolone
40 mg of triamcinolone (Trigon Depot®) in each of the web spaces affected with Morton neuroma is injected. Up to 4 injections are allow in the first three months of follow-up
Device: ultrasound guided injection · Drug: guided injection of mepivacaine · Drug: guided injection of Triamcinolone
Introduction of a needle based in anatomical landmark
Also known as: Blind introduction of the needle
blind injection of 1 cc of Mepivacaine Normon 2% ®
blind injection of 40 mg of triamcinolone (trigon depot ®)
Also known as: Blind introduction of Triamcinolone
Introduction of a needle based guided by ultrasound
Also known as: guided introduction of the needle
ultrasound guided injection of 1 cc of Mepivacaine Normon 2% ®
Also known as: guided perineural injection
ultrasound guided injection of 40 mg of triamcinolone (trigon depot ®)
Also known as: guided perineural injection
Pain (VAS score)
Pain relieve
Time frame: 1 year
Manchester foot pain and disability index
Disability measurement
Time frame: 1 year
Generic quality-of-life instrument, the EQ-5D
Quality of life measurement
Time frame: 1 year
Plan to share: Yes — our idea is to publish the short term results and the long term results in order to influence management of this pathology. Tables and statistical analysis will be available for review and metaanalysis.
This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Complejo Hospitalario Universitario de Granada